title: A PHASE 4, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF CONTINUED ENZALUTAMIDE TREATMENT BEYOND PROGRESSION IN PATIENTS WITH CHEMOTHERAPY-NAÏVE METASTATIC CASTRATION-RESISTANT PROSTATE CANCER

acronym: PLATO

summary: The purpose of this study is to determine if continued treatment with Enzalutamide is effective in patients with metastatic prostate cancer.

ReferenceCitation: Attard G, Borre M, Gurney H, Loriot Y, Andresen-Daniil C, Kalleda R, Pham T, Taplin ME; PLATO collaborators. Abiraterone Alone or in Combination With Enzalutamide in Metastatic Castration-Resistant Prostate Cancer With Rising Prostate-Specific Antigen During Enzalutamide Treatment. J Clin Oncol. 2018 Sep 1;36(25):2639-2646. doi: 10.1200/JCO.2018.77.9827. Epub 2018 Jul 20.

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

lead_sponsor: Pfizer

location_country:
Denmark
Spain
Italy
United Kingdom
Australia
Finland
United States
France
Belgium
Sweden
Slovakia

location_facility: GAMMALAB, spol.s r.o., Oddelenie nuklearnej mediciny

location_facility: Farmacia, Azienda Ospedaliera "Istituti Ospitalieri" di Cremona

location_facility: Institut Gustave Roussy - Service d'Urologie

location_facility: Hospital Universitario Madrid Sanchinarro

location_facility: Medicina Nucleare, Azienda Ospedaliera "Istituti Ospitalieri" di Cremona

location_facility: Farmacia, Azienda Ospedaliera S. Camillo Forlanini

location_facility: Institut nuklearnej a molekularnej mediciny

location_facility: Servizio di Radiologia, Azienda Ospedaliera "Istituti Ospitalieri" di Cremona

location_facility: Farmacia Ospedaliera, A.O.U. San Luigi Gonzaga

location_facility: Azienda Ospedaliera S. Camillo Forlanini, UOC per il governo clinico in Oncologia Medica

location_facility: Port Macquarie Base Hospital,North Coast Cancer Institute

location_facility: SCDU Oncologia Medica II Pad, A.O.U. San Luigi Gonzaga

location_facility: U.O. Oncologia Medica, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura

location_facility: Helsingin yliopistollinen keskussairaala, Meilahden sairaala

location_facility: Epic Pharmacy Port Macquarie base hospital

location_facility: Concord Cancer Centre, Medical Oncology Department

location_facility: ALTAHIA, Xarxa Assistencial Universitaria de Manresa

location_facility: U.O di Oncologia-Presidio Ospedaliero di Cremona-Istituti Ospitalieri di Cremona

location_facility: CO Badalona-Instituto Germans Trias i Pujol

location_facility: Apoteket AB Kliniska Provningar Molnlycke

location_facility: SCDU Radiodiagnostica, A.O.U. San Luigi Gonzaga

location_facility: Tenpharm Pty Ltd trading as EPIC Pharmacy Tennyson

location_facility: Uroexam, spol. s r.o., Urologicka ambulancia

location_facility: Fakultna nemocnica s poliklinikou F.D. Roosevelta

location_facility: UOC Radiologia Piasta, Azienda Ospedaliera S. Camillo Forlanini

location_facility: SS Medicina Nucleare, A.O.U. San Luigi Gonzaga

location_facility: North Shore Radiology and Nuclear Medicine

location_facility: University College London Hospitals NHS Foundation Trust


status: Completed

primary_purpose: Treatment

intervention_type: Drug

title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Study to Assess the Safety and Efficacy of UX007 in Subjects With Glucose Transporter Type 1 Deficiency Syndrome

study_completion_date_type: Actual

lead_sponsor: Ultragenyx Pharmaceutical Inc

source: euctr

design_allocation: Randomized

study_start_date_type: Actual

study_type: Interventional

ReferenceType: derived

ReferenceCitation: Striano P, Auvin S, Collins A, Horvath R, Scheffer IE, Tzadok M, Miller I, Kay Koenig M, Lacy A, Davis R, Garcia-Cazorla A, Saneto RP, Brandabur M, Blair S, Koutsoukos T, De Vivo D. A randomized, double-blind trial of triheptanoin for drug-resistant epilepsy in glucose transporter 1 deficiency syndrome. Epilepsia. 2022 Jul;63(7):1748-1760. doi: 10.1111/epi.17263. Epub 2022 May 21.

enrollment_type: Actual

location_country:
Spain
Italy
United Kingdom
Australia
United States
Israel
France

location_facility: Children's Hospital Colorado - University of Colorado, Denver, School of Medicine

location_facility: University of Texas Neurometabolic Clinic

location_facility: Columbia University - Department of Neurology

location_facility: Service de Neurologie Pédiatrique et des Maladies Métaboliques - INSERM U1141 Hôpital Robert Debré - APHP

location_facility: Unita' Operativa Neurologia Pediatrica e Malattie Muscolari Istituto "Giannina Gaslini"

summary: The primary objectives of the study are to evaluate the efficacy of UX007 compared to placebo as measured by the reduction from randomization to Week 8 in frequency of seizures and to evaluate the safety of UX007 via adverse event (AE) rates, laboratory values, and electrocardiogram (ECG).

lead_sponsor_type: industriel

status_simplified: Completed


type: EudraCT Number

title: An Open-Label, Multicenter Study To Evaluate The Efficacy And Safety Of Sofosbuvir/Ledipasvir Fixed-Dose Combination ± Ribavirin For 12 or 24 Weeks In Chronic Genotype 1 HCV Infected Subjects Who Participated In A Prior Gilead-Sponsored HCV Treatment Study

summary: The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) with or without ribavirin (RBV) in participants with chronic genotype 1 hepatitis C virus (HCV) infection who have participated in a prior Gilead-sponsored HCV treatment study, and who did not achieve sustained virologic response (SVR24), defined as HCV RNA < lower limit of quantification (LLOQ) 24 weeks after last dose of study drug (SVR24).

design_allocation: Non-Randomized

ReferenceType: background

ReferenceCitation: Lawitz E, Pockros PJ, Yang JC, Pang PS, Zhu Y, Svarovskaia E, et al. Ledipasvir/sofosbuvir regimens for the retreatment of patients who failed sofosbuvir-based regimens [Abstract 10868]. Presented at: The 25th Conference of the Asian Pacific Association for the Study of Liver (APASL); 2016 February 20-24; Tokyo, Japan.

ReferenceCitation: Lawitz E, Flamm S, Yang JC, Pang PS, Zhu Y, Svarovskaia E, et al. Retreatment of patients who failed 8 or 12 weeks of ledipasvir/sofosbuvir-based regimens with ledipasvir/sofosbuvir for 24 weeks [Abstract 1627]. Presented at: The 50th Annual Congress of the European Association for the Study of Liver: The International Liver Congress (EASL); 2015 April 22-26; Vienna, Austria

ReferenceType: result

ReferenceCitation: Wyles D, Pockros P, Morelli G, Younes Z, Svarovskaia E, Yang JC, Pang PS, Zhu Y, McHutchison JG, Flamm S, Lawitz E. Ledipasvir-sofosbuvir plus ribavirin for patients with genotype 1 hepatitis C virus previously treated in clinical trials of sofosbuvir regimens. Hepatology. 2015 Jun;61(6):1793-7. doi: 10.1002/hep.27814. Epub 2015 Apr 27.

ipd_sharing: Yes

ipd_sharing_description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.

lead_sponsor: Gilead Sciences

location_country:
Spain
Australia
Puerto Rico
United States
France


intervention_type: Biological

title: A Phase 2, Prospective Study Of PRM-151 In Subjects With Primary Myelofibrosis (PMF), Post-Polycythemia Vera MF (Post-PV MF), Or Post-Essential Thrombocythemia MF (Post-ET MF)

lead_sponsor: Hoffmann-La Roche

type: Other Identifier

ipd_sharing_description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

location_country:
United Kingdom
Italy
Netherlands
Canada
United States
Israel
France
Germany

location_facility: Johannes Wesling Academic Medical Center

summary:
RO7490677 is an investigational drug that is being developed for possible use in the treatment of myelofibrosis (MF), a disease in which the bone marrow, which is the organ in the body that makes blood cells, is replaced by fibrosis, or excess scar tissue.

The purpose of this study is to gather information on whether RO7490677 has an effect on the MF disease, whether it is safe in patients with MF, and how well it is tolerated.


title: Natural History of Progression of Atrophy Secondary to Stargardt Disease: Retrospective, and Prospective Longitudinal Observational Study Incl. Ancillary SMART Study- Scotopic Microperimetric Assessment of Rod Function in Stargardt Disease

acronym: ProgSTAR

summary:
Stargardt disease is currently an incurable and untreatable macular dystrophy that causes severe visual loss in children and young adults, thereby causing enormous morbidity with economic, psychological, emotional, and social implications. There are no FDA approved therapeutic treatments for this disease. Therefore, the objective of this study is to collect natural history data from a large population of children and adults in order to evaluate possible efficacy measures for planned clinical trials.

Participants will be recruited from each Investigator's own patient population as the study requires the availability of both multiyear retrospective data, as well as ongoing prospectively collected data. A concurrent ancillary study (SMART study) is also being conducted with a subset of the prospective study patients during their regular ProgSTAR study visits to expand the collection of retinal images to include microperimetry measurements gathered under scotopic (low light) conditions.

study_type: Observational

time_perspective: Other

ReferenceCitation: Schönbach EM, Ibrahim MA, Strauss RW, Birch DG, Cideciyan AV, Hahn GA, Ho A, Kong X, Nasser F, Sunness JS, Zrenner E, Sadda SR, West SK, Scholl HPN; Progression of Stargardt Disease Study Group. Fixation Location and Stability Using the MP-1 Microperimeter in Stargardt Disease: ProgStar Report No. 3. Ophthalmol Retina. 2017 Jan - Feb;1(1):68-76. doi: 10.1016/j.oret.2016.08.009. Epub 2016 Oct 31.

ReferenceCitation: Kong X, West SK, Strauss RW, Munoz B, Cideciyan AV, Michaelides M, Ho A, Ahmed M, Schönbach EM, Cheetham JK, Ervin AM, Scholl HPN; ProgStar study group. Progression of Visual Acuity and Fundus Autofluorescence in Recent-Onset Stargardt Disease: ProgStar Study Report #4. Ophthalmol Retina. 2017 Nov - Dec;1(6):514-523. doi: 10.1016/j.oret.2017.02.008. Epub 2017 Apr 28.

ReferenceCitation: Strauss RW, Muñoz B, Ho A, Jha A, Michaelides M, Mohand-Said S, Cideciyan AV, Birch D, Hariri AH, Nittala MG, Sadda S, Scholl HPN; ProgStar Study Group. Incidence of Atrophic Lesions in Stargardt Disease in the Progression of Atrophy Secondary to Stargardt Disease (ProgStar) Study: Report No. 5. JAMA Ophthalmol. 2017 Jul 1;135(7):687-695. doi: 10.1001/jamaophthalmol.2017.1121.

ReferenceCitation: Schönbach EM, Wolfson Y, Strauss RW, Ibrahim MA, Kong X, Muñoz B, Birch DG, Cideciyan AV, Hahn GA, Nittala M, Sunness JS, Sadda SR, West SK, Scholl HPN; ProgStar Study Group. Macular Sensitivity Measured With Microperimetry in Stargardt Disease in the Progression of Atrophy Secondary to Stargardt Disease (ProgStar) Study: Report No. 7. JAMA Ophthalmol. 2017 Jul 1;135(7):696-703. doi: 10.1001/jamaophthalmol.2017.1162.

ReferenceCitation: Strauss RW, Ho A, Muñoz B, Cideciyan AV, Sahel JA, Sunness JS, Birch DG, Bernstein PS, Michaelides M, Traboulsi EI, Zrenner E, Sadda S, Ervin AM, West S, Scholl HP; Progression of Stargardt Disease Study Group. The Natural History of the Progression of Atrophy Secondary to Stargardt Disease (ProgStar) Studies: Design and Baseline Characteristics: ProgStar Report No. 1. Ophthalmology. 2016 Apr;123(4):817-28. doi: 10.1016/j.ophtha.2015.12.009. Epub 2016 Jan 16.

ReferenceCitation: Kong X, Strauss RW, Michaelides M, Cideciyan AV, Sahel JA, Muñoz B, West S, Scholl HP; ProgStar Study Group. Visual Acuity Loss and Associated Risk Factors in the Retrospective Progression of Stargardt Disease Study (ProgStar Report No. 2). Ophthalmology. 2016 Sep;123(9):1887-97. doi: 10.1016/j.ophtha.2016.05.027. Epub 2016 Jul 2.

ReferenceCitation: Kong X, Strauss RW, Cideciyan AV, Michaelides M, Sahel JA, Munoz B, Ahmed M, Ervin AM, West SK, Cheetham JK, Scholl HPN; ProgStar Study Group. Visual Acuity Change over 12 Months in the Prospective Progression of Atrophy Secondary to Stargardt Disease (ProgStar) Study: ProgStar Report Number 6. Ophthalmology. 2017 Nov;124(11):1640-1651. doi: 10.1016/j.ophtha.2017.04.026. Epub 2017 May 23.

ReferenceCitation: Strauss RW, Muñoz B, Ho A, Jha A, Michaelides M, Cideciyan AV, Audo I, Birch DG, Hariri AH, Nittala MG, Sadda S, West S, Scholl HPN; ProgStar Study Group. Progression of Stargardt Disease as Determined by Fundus Autofluorescence in the Retrospective Progression of Stargardt Disease Study (ProgStar Report No. 9). JAMA Ophthalmol. 2017 Nov 1;135(11):1232-1241. doi: 10.1001/jamaophthalmol.2017.4152.

ReferenceCitation: Kong X, Fujinami K, Strauss RW, Munoz B, West SK, Cideciyan AV, Michaelides M, Ahmed M, Ervin AM, Schönbach E, Cheetham JK, Scholl HPN; ProgStar Study Group. Visual Acuity Change Over 24 Months and Its Association With Foveal Phenotype and Genotype in Individuals With Stargardt Disease: ProgStar Study Report No. 10. JAMA Ophthalmol. 2018 Aug 1;136(8):920-928. doi: 10.1001/jamaophthalmol.2018.2198.

lead_sponsor: Foundation Fighting Blindness

location_country:
Germany
United States
United Kingdom
France

location_facility: Wilmer Eye Institute, Johns Hopkins University

location_facility: Scheie Eye Institute, University of Pennsylvania

location_facility: Center for Ophthalmic Research, University of Teubingen


title: A Randomized Double-blind, Placebo-controlled, Parallel-group, Multicenter, Phase 3 Study to Evaluate the Long-term Safety of Naldemedine for the Treatment of Opioid-induced Constipation in Subjects With Non-malignant Chronic Pain Receiving Opioid Therapy

summary: The purpose of this study is to evaluate the long-term safety of naldemedine for the treatment of constipation due to opioid therapy.

ReferenceCitation: Camilleri M, Hale M, Morlion B, Tack J, Webster L, Wild J. Naldemedine Improves Patient-Reported Outcomes of Opioid-Induced Constipation in Patients with Chronic Non-Cancer Pain in the COMPOSE Phase 3 Studies. J Pain Res. 2021 Jul 16;14:2179-2189. doi: 10.2147/JPR.S282738. eCollection 2021.

ReferenceCitation: Webster LR, Hale ME, Yamada T, Wild JE. A Renal Impairment Subgroup Analysis of the Safety and Efficacy of Naldemedine for the Treatment of Opioid-Induced Constipation in Patients with Chronic Non-Cancer Pain Receiving Opioid Therapy. J Pain Res. 2020 Mar 24;13:605-612. doi: 10.2147/JPR.S237833. eCollection 2020.

ReferenceCitation: Wild J, Webster L, Yamada T, Hale M. Safety and Efficacy of Naldemedine for the Treatment of Opioid-Induced Constipation in Patients with Chronic Non-Cancer Pain Receiving Opioid Therapy: A Subgroup Analysis of Patients ≥ 65 Years of Age. Drugs Aging. 2020 Apr;37(4):271-279. doi: 10.1007/s40266-020-00753-2.

lead_sponsor: Shionogi

location_country:
Denmark
Poland
Spain
Italy
Austria
Australia
United Kingdom
Canada
Sweden
Hungary
United States
France
Israel
South Africa
Germany
Czechia


title: Natural History Study of Children With Metachromatic Leukodystrophy

summary: The purpose of this study is evaluate the natural course of disease progression related to gross motor function in children with metachromatic leukodystrophy (MLD).

status: Terminated

time_perspective: Prospective

lead_sponsor: Shire

location_country:
Denmark
Brazil
Argentina
Canada
United States
France
Turkey
Belgium
Japan
Germany

location_facility: Hospital de Cllnicas de Porto Alegre (HCPA) / UFRGS

location_facility: Hacettepe Universitesi Tip Fakultesi Onkoloji Hastanesi

location_facility: Copenhagen University Hospital, Rigshospitalet

location_facility: The Jikei University School Of Medicine - Institute Of Dna Medicine

location_facility: Universitair Ziekenhuis Antwerpen (UZA) (University Hospital Antwerpen)

location_facility: Univesitatsklinikum Tubingen Klinik fur Kinder und Jugendmedizin

location_facility: Ann & Robert H. Lurie Children's Hospital of Chicago

location_facility: Faculty Of Medicine, Osaka University Graduate School Of Medicine

status_simplified: Unknown


title: A Phase II Study of Pazopanib GW786034, NSC# 737754 in Children, Adolescents and Young Adults With Refractory Solid Tumors

lead_sponsor: Novartis Pharmaceuticals

ipd_sharing_description:
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

location_country:
Spain
Canada
Hungary
United States
France
Slovakia
Czechia

summary: The study design was an open-label Phase II pediatric clinical study. The purpose of Study X2203 was to identify any efficacy signal in subjects with the disease subtypes under study, when treated with pazopanib monotherapy. Furthermore, it was to define the toxicities of pazopanib in children, as well as examine biological markers, e.g. cytokines and angiogenic factors, that could help further characterize any response of pazopanib in children. Pazopanib was administered as monotherapy in tablet and powder suspension formulations at daily doses of 450 mg/m2/dose or 225 mg/m2/dose, respectively. The first 6 enrolled subjects receiving oral suspension formulation were assessed for tolerability and extended PK sampling; and, only if pazopanib was tolerated, subsequent subjects were enrolled at the same starting dose with the suspension. Dose escalation was not permitted. For the tablet, a dosing nomogram was used based on the subject's BSA. Dose reduction was dependent upon the toxicity of pazopanib and disease status of the infants, toddlers, children, adolescents, and young adults. Subjects could be as young as 1 year-old infants to screen for enrollment. Subjects were assessed for initial response after 8 weeks of treatment prior to Cycle 3. A cycle was defined as 28 days of pazopanib treatment with no rest period between cycles. Treatment was administered continuously once daily. Treatment was to be discontinued if there was evidence of disease progression, unacceptable treatment-related toxicity, pregnancy. Histological classification was an important diagnostic inclusion in these subjects with a wide variety of refractory solid tumors, i.e. 7 different tumor types and each being a cohort.


title: A Controlled, Assessor-blind, Parallel Groups, Multicentre, Multinational Trial Evaluating the Immunogenicity of FE 999049 in Repeated Cycles of Controlled Ovarian Stimulation in Women Undergoing an Assisted Reproductive Technology Programme

summary: This trial investigates the immunogenicity of FE 999049 in repeated cycles.

ReferenceCitation: Havelock J, Aaris Henningsen AK, Mannaerts B, Arce JC; ESTHER-1 and ESTHER-2 Trial Groups. Pregnancy and neonatal outcomes in fresh and frozen cycles using blastocysts derived from ovarian stimulation with follitropin delta. J Assist Reprod Genet. 2021 Oct;38(10):2651-2661. doi: 10.1007/s10815-021-02271-5. Epub 2021 Jul 13.

ReferenceCitation: Nelson SM, Larsson P, Mannaerts BMJL, Nyboe Andersen A, Fauser BCJM. Anti-Müllerian hormone variability and its implications for the number of oocytes retrieved following individualized dosing with follitropin delta. Clin Endocrinol (Oxf). 2019 May;90(5):719-726. doi: 10.1111/cen.13956. Epub 2019 Mar 18.

lead_sponsor: Ferring Pharmaceuticals

location_country:
Denmark
Poland
Brazil
Spain
Italy
Russian Federation
United Kingdom
Canada
France
Belgium
Czechia

location_facility: Centro Natalità San Raffaele (there may be other sites in this country)

location_facility: Rigshospitalet Fertilitetsklinikken (there may be other sites in this country)

location_facility: Department of Endocrine Gynaecology and Reproductive Medicine, Hôpital Jeanne de Flandre (there may be other sites in this country)

location_facility: Fertilitat and PUC-RS (there may be other sites in this country)

location_facility: IVF CUBE SE (there may be other sites in this country)

location_facility: IVI Sevilla (there may be other sites in this country)

location_facility: The nOvum Clinic (there may be other sites in this country)

location_facility: Glasgow Centre for Reproductive Medicine Ltd. (there may be other sites in this country)

location_facility: Pacific Centre for Reproductive Medicine

location_facility: IVF & Reproductive Genetics Center (there may be other sites in this country)

location_facility: UZ Brussel (there may be other sites in this country)


title: A Randomised, Controlled, Assessor-blind, Parallel Groups, Multicentre, Multinational Trial Comparing the Efficacy and Safety of FE 999049 With Follitropin Alfa (GONAL-F) in Controlled Ovarian Stimulation in Women Undergoing an Assisted Reproductive Technology Programme

summary: This trial investigates the effects of FE 999049 compared to GONAL-F.

ReferenceCitation: Arce JC, Larsson P, García-Velasco JA. Establishing the follitropin delta dose that provides a comparable ovarian response to 150 IU/day follitropin alfa. Reprod Biomed Online. 2020 Oct;41(4):616-622. doi: 10.1016/j.rbmo.2020.07.006. Epub 2020 Jul 15.

ReferenceCitation: Ishihara O, Nelson SM, Arce JC. Comparison of ovarian response to follitropin delta in Japanese and White IVF/ICSI patients. Reprod Biomed Online. 2022 Jan;44(1):177-184. doi: 10.1016/j.rbmo.2021.09.014. Epub 2021 Sep 23.

ReferenceCitation: Nyboe Andersen A, Nelson SM, Fauser BC, García-Velasco JA, Klein BM, Arce JC; ESTHER-1 study group. Individualized versus conventional ovarian stimulation for in vitro fertilization: a multicenter, randomized, controlled, assessor-blinded, phase 3 noninferiority trial. Fertil Steril. 2017 Feb;107(2):387-396.e4. doi: 10.1016/j.fertnstert.2016.10.033. Epub 2016 Nov 29.


title: Phase II Randomized Double Blind Placebo Controlled Trial of Combination of Pimasertib With SAR245409 or of Pimasertib With SAR245409 Placebo in Subjects With Previously Treated Unresectable Low Grade Ovarian Cancer

summary: This is a double blind, randomized, placebo-controlled, 2-arm, Phase 2 trial investigating the efficacy and safety of combination therapy of pimasertib plus SAR245409 and pimasertib placebo administered once per day compared to pimasertib administered twice per day plus SAR245409 placebo administered once per day in participants with previously treated unresectable low-grade serous ovarian or peritoneal carcinoma or serous borderline ovarian or peritoneal tumors.

lead_sponsor: EMD Serono

location_country:
Poland
Spain
Australia
Canada
United States
France
Belgium


title: OPTIMIS - Outcomes of HCC Patients Treated With TACE Followed or Not Followed by Sorafenib and the Influence of Timing to Initiate Sorafenib

acronym: OPTIMIS

summary: This study will collect data of patients who are treated with TACE followed by sorafenib for hepatocellular carcinoma (HCC) or patients without Sorafenib after TACE. In contrast to a prior observational study on sorafenib (GIDEON study), where pre-treatment with TACE was documented retrospectively, this study will collect more detailed information about the TACE treatment and the status of a patient when treatment with sorafenib is started.

lead_sponsor: Bayer

location_country:
Spain
Kazakhstan
Japan
Czechia
Poland
Hong Kong
Austria
Russian Federation
Indonesia
India
Israel
Turkey
Mexico
Singapore
Sweden
Slovakia
Egypt
Brazil
Canada
Switzerland
Hungary
China
Denmark
Taiwan
Greece
Thailand
Vietnam
Korea, Republic of
France
Netherlands
Pakistan

intervention_type: Procedure


title: A Phase I/II, Multi-center, Dose-escalating Study of the Tolerability, Pharmacokinetics, and Clinical Activity of the Combined Administration of Oral Rigosertib With Azacitidine in Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia

summary: This study, is a Phase I/II clinical trial in three parts: Phase I Dose Escalation, Phase II, Part 1 RPTD Cohort, and Phase II, Part 2 Expansion. The first two parts have been completed. The Phase II, Part 2 Expansion will assess if treatment with rigosertib in combination with azacitidine, has measurable effects in patients with myelodysplastic syndrome (MDS). Safety of patients is an objective throughout all parts of the study.

ReferenceCitation: Navada SC, Silverman LR. The safety and efficacy of rigosertib in the treatment of myelodysplastic syndromes. Expert Rev Anticancer Ther. 2016 Aug;16(8):805-10. doi: 10.1080/14737140.2016.1209413. Epub 2016 Jul 15. Review.

ReferenceCitation: Chaurasia, P. et al. Rigosertib in Combination with Azacitidine Modulates Epigenetic Pathways and can Overcome Clinical Resistance to Hypomethylating Agents in Myelodysplastic Syndromes (MDS). Leukemia Research , Volume 55 , S121, April 2017; MDS 2017.

ReferenceCitation: Garcia-Manero G, Fenaux P. Comprehensive Analysis of Safety: Rigosertib in 557 Patients with Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML). Blood Dec 2016, 128 (22) 2011; ASH 2016.

ReferenceCitation: Navada S, Garcia-Manero G. Combination of Oral Rigosertib and Injectable Azacitidine in Patients with Myelodysplastic Syndromes (MDS): Results from a Phase II Study. Blood Dec 2016, 128 (22) 3167; ASH 2016.

ReferenceCitation: Navada, S. et al. Combination of Oral Rigosertib and Injectable Azacitidine in Patients with Myelodysplastic Syndromes (MDS). Leukemia Research , Volume 55 , S30, April 2017; MDS 2017.

ReferenceCitation: Navada SC, Garcia-Manero G, OdchimarReissig R, Pemmaraju N, Alvarado Y, Ohanian MN, John RB, Demakos EP, Zbyszewski PS, Maniar M, Woodman RC, Fruchtman SM, Silverman LR. Rigosertib in combination with azacitidine in patients with myelodysplastic syndromes or acute myeloid leukemia: Results of a phase 1 study. Leuk Res. 2020 Jul;94:106369. doi: 10.1016/j.leukres.2020.106369. Epub 2020 May 12.

lead_sponsor: Onconova Therapeutics, Inc.

location_country:
United States
France

location_facility: Desert Hematology Oncology Medical Group, Inc.

location_facility: White Plains Hospital Center for Cancer Care

location_facility: Carolina Blood and Cancer Care Associates

location_facility: Froedtert Hospital and the Medical College of Wisconsin

location_facility: The University of Texas MD Anderson Cancer Center


title: A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group, Dose-finding, Pivotal, Phase 2b/3 Study to Evaluate the Efficacy, Safety, and Tolerability of Intravenous BYM338 at 52 Weeks on Physical Function, Muscle Strength, and Mobility and Additional Long Term Safety up to 2 Years in Patients With Sporadic Inclusion Body Myositis

acronym: RESILIENT

summary: This study evaluated the efficacy, safety and tolerability of multiple doses of bimagrumab/BYM338 vs placebo, when administered intravenously (i.v.), on physical function, muscle strength, and mobility in patients with sporadic inclusion body myositis (sIBM).

ReferenceCitation: Hanna MG, Badrising UA, Benveniste O, Lloyd TE, Needham M, Chinoy H, Aoki M, Machado PM, Liang C, Reardon KA, de Visser M, Ascherman DP, Barohn RJ, Dimachkie MM, Miller JAL, Kissel JT, Oskarsson B, Joyce NC, Van den Bergh P, Baets J, De Bleecker JL, Karam C, David WS, Mirabella M, Nations SP, Jung HH, Pegoraro E, Maggi L, Rodolico C, Filosto M, Shaibani AI, Sivakumar K, Goyal NA, Mori-Yoshimura M, Yamashita S, Suzuki N, Katsuno M, Murata K, Nodera H, Nishino I, Romano CD, Williams VSL, Vissing J, Auberson LZ, Wu M, de Vera A, Papanicolaou DA, Amato AA; RESILIENT Study Group. Safety and efficacy of intravenous bimagrumab in inclusion body myositis (RESILIENT): a randomised, double-blind, placebo-controlled phase 2b trial. Lancet Neurol. 2019 Sep;18(9):834-844. doi: 10.1016/S1474-4422(19)30200-5.

location_country:
Denmark
United Kingdom
Italy
Australia
Switzerland
United States
France
Belgium
Japan
Netherlands


title: A Phase II Trial to Assess the Efficacy and Safety of Pasireotide s.c. Alone or in Combination With Cabergoline in Patients With Cushing's Disease

location_country:
Brazil
Belgium
Spain
Greece
Italy
Mexico
Netherlands
Argentina
Hungary
United States
France
India
Malaysia
Colombia
Turkey
Germany

location_facility: University of Alabama at Birmingham The Kirklin Clinic

location_facility: Oregon Health and Science University SOM230B2411

summary: The main purpose of this prospective, multicenter, open-label phase II study, was to evaluate the efficacy and safety of pasireotide alone or in combination with cabergoline in patients with Cushing's disease.


title: A 104-Week, Flexible-Dose, Open-Label, Multicenter, Extension Study to Evaluate the Long-Term Safety and Effectiveness of Lurasidone in Pediatric Subjects

lead_sponsor: Sunovion

ReferenceCitation: DelBello MP, Tocco M, Pikalov A, Deng L, Goldman R. Tolerability, Safety, and Effectiveness of Two Years of Treatment with Lurasidone in Children and Adolescents with Bipolar Depression. J Child Adolesc Psychopharmacol. 2021 Sep;31(7):494-503. doi: 10.1089/cap.2021.0040. Epub 2021 Jul 29.

location_country:
Poland
Romania
Spain
Russian Federation
Mexico
Ukraine
Hungary
Korea, Republic of
United States
France
Puerto Rico
Colombia
Philippines
Malaysia
Bulgaria

location_facility: Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu, Oddzial Kliniczmy VI Psychiatrii Mlodziezy

location_facility: University of California San Francisco Medical Center

location_facility: University of South Florida Rothman Center of Neuropychiatry

location_facility: West Visayas State University Medical Center

location_facility: Family Psychiatry of The Woodlands, P.A.

location_facility: CI Lviv Regional Clinical Psychiatric Hospital

location_facility: Centro de Investigaciones y Proyectos en Neurociencias CIPNA

location_facility: Ternopil RCCPH Dept of Psychiatry #9 (adolescent)& #8 (pediatric) Ternopil I.Ya. Gorbachevskyi SMU

location_facility: Centro de Investigaciones del Sistema Nervioso Limitada - Grupo CISNE Ltda

location_facility: Medical Research Group of Central Florida

location_facility: Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia

location_facility: Instituto de Investigaciones Aplicadas a la Neurociencia A.C.

location_facility: Reg. Psych. Hosp.n.a. O.Yuschenko, Dept. #121 VNMI

location_facility: University Hospitals Case Medical Center

location_facility: Spitalul Clinic de Urgenta pentru Copii "Louis Turcanu" Timisoara

location_facility: GUZ Lipetsk Regional psychoneurological Hospital #1

location_facility: Closed corporation "Scientific Center of Personalized Psychiatry"

location_facility: Centro para el Desarrollo de la Medicina y de Asistencia Medica Especializada S.C.

location_facility: Neuropsychiatric Research Center of Orange County

location_facility: The Ohio State University Nisonger Center

location_facility: Odesa Regional Psychoneurological Dispensary, Outpatient Dept.

location_facility: Sverdiovsk Regional Clinical Psychiatric Hospital

location_facility: Regional Clinical Mental Hospital of Saint Sofiya

location_facility: CI Kherson Regional Psychiatric Hospital of Kherson RC

location_facility: Centro de Investigacion Clinica Psiquiatrica

location_facility: SI Institute of Neurology, Psychiatry and Narcology of NAMSU

location_facility: O.F. Maltcev Poltava RCPsH Children Dept Ukrainian Medical Stomatological Academy

location_facility: Vadaskert Alapitvany a Gyermekek Lelki Egeszsegeert

location_facility: State Healthcare Institution of Nizhniy Novgordo region "Clinical Psychiatric Hospital #1 of City of Nizhniy Novgorod"

location_facility: Alexian Brothers Health and Wellness Center

location_facility: State Healthcare Institution of Yaroslavl Rgion "Yaroslavl Regional clinical Mental Hospital"

location_facility: Lake Charles Clinical Trials LLC,2770 3rd Avenue,Suite 340

location_facility: TMA Psychiatry in Kyiv Center of NT & Rehabilitation of Psychotic Conditions

location_facility: SI Institute of Children and Adolescents Healthcare of NAMSU

location_facility: SHI "City Psychoneurological dispensary #7 (with Hospital)"

location_facility: Instituto de Informacion de Investigacion en Salud Mental

location_facility: Center of Recovery Treatment "Pediatric Psychiatry" named after S.S. Mnukhin

location_facility: FSBSI "Scientific Research Institute of Mental Health"

location_facility: RPsH #3 Сhildren Dept SHEI Ivano-Frankivsk SMU

summary: This is an open-label, 104-week, multicenter, extension study designed to evaluate the long-term safety, tolerability and effectiveness of flexibly dosed lurasidone (20, 40, 60 or 80 mg/day) in pediatric subjects who have completed the 6-week treatment period in the preceding studies, D1050301, D1050325, and D1050326


title: A Single-arm Study to Assess the Efficacy and Safety of Oral Rigosertib in Transfusion-dependent, Low or Intermediate-1, Myelodysplastic Syndrome Patients Based on the International Prognostic Scoring System

publications_result: Garcia-Manero G, Fenaux P. Comprehensive Analysis of Safety: Rigosertib in 557 Patients with Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML). Blood Dec 2016, 128 (22) 2011; ASH 2016.

ReferenceCitation: Seetharam M, Fan AC, Tran M, Xu L, Renschler JP, Felsher DW, Sridhar K, Wilhelm F, Greenberg PL. Treatment of higher risk myelodysplastic syndrome patients unresponsive to hypomethylating agents with ON 01910.Na. Leuk Res. 2012 Jan;36(1):98-103. doi: 10.1016/j.leukres.2011.08.022. Epub 2011 Sep 14.

location_country:
Germany
United States
France

location_facility: Anschutz Cancer Pavilion University of Colorado

location_facility: Greenbaum Cancer Center University of Maryland

location_facility: Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden

location_facility: Hôpital Saint-Louis, Service d'Hématologie

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Washington Cancer Institute at Medstar Washington Hospital Center

summary: The study will enroll low risk MDS patients who need red blood cell transfusions and who are refractory to or are not using erythropoiesis-stimulating agents. The purpose of the study is to determine whether oral rigosertib treatment results in hematological improvements according to the 2006 International Working Group criteria in these patients. The study will also record any side effects that may occur during the study.


title: A Phase Ib, Open-Label, Multicenter Study to Investigate the Pharmacokinetics, Pharmacodynamics, and Safety of Tocilizumab Following Subcutaneous Administration to Patients With Systemic Juvenile Idiopathic Arthritis

summary: This open-label, multicenter study will evaluate the pharmacokinetics, pharmacodynamics, and safety of subcutaneously administered tocilizumab in participants with Systemic Juvenile Idiopathic Arthritis (sJIA). Participants with body weight less than (<) 30 kilograms (kg) will receive subcutaneous (SC) tocilizumab dose every 2 weeks (Q2W) and participants with body weight greater than or equal to (>=) 30 kg will receive weekly (QW), for 52 weeks. Tocilizumab was administered every 10 days until pre-planned interim analysis was performed and changed to Q2W in participants with body weight <30 kg.

ReferenceCitation: Ruperto N, Brunner HI, Ramanan AV, Horneff G, Cuttica R, Henrickson M, Anton J, Boteanu AL, Penades IC, Minden K, Schmeling H, Hufnagel M, Weiss JE, Pardeo M, Nanda K, Roth J, Rubio-Pérez N, Hsu JC, Wimalasundera S, Wells C, Bharucha K, Douglass W, Bao M, Mallalieu NL, Martini A, Lovell D, Benedetti F; Paediatric Rheumatology INternational Trials Organisation (PRINTO) and the Paediatric Rheumatology Collaborative Study Group (PRCSG). Subcutaneous dosing regimens of tocilizumab in children with systemic or polyarticular juvenile idiopathic arthritis. Rheumatology (Oxford). 2021 Oct 2;60(10):4568-4580. doi: 10.1093/rheumatology/keab047.

location_country:
Brazil
Spain
Italy
Russian Federation
Australia
United Kingdom
Argentina
Canada
United States
France
Mexico
Germany

location_facility: Hospital das Clinicas - FMUSP; Instituto da Crianca - Reumatologia

location_facility: FSBI "Scientific Research Institute of Rheumatology" of russian Academy of Medical Sciences

location_facility: Hospital Universitario la Fe: Servicio de Reumatologia Pediatrica

location_facility: Levine Children's Hospital; Divison of Pediatric Rheumatology; Department of Pediatrics

location_facility: Ann & Robert H. Lurie Children's Hospital of Chicago; Division of Rheumatology

location_facility: Nuovo Ospedale Pediatrico Meyer; Reumatologia - Clinica Pediatrica 1°

location_facility: Hospital de Ninos de la Santisima Trinidad; Reumatologia Infantil

location_facility: Hospital Sant Joan De Deu; Servicio de Reumatologia Pediatrica

location_facility: Royal Children'S Hospital; Paediatric Rheumatology

location_facility: The University of Chicago;Department of Pediatrics

location_facility: SI Sceintific children health center RAMS

location_facility: Hospital de La Paz; Unidad de Reumatologia Pediatrica

location_facility: Great Ormond Street Hospital; Somers Clinical Research Facility

location_facility: Istituto Giannina Gaslini-Ospedale Pediatrico IRCCS

location_facility: University of Utah; Immunology/Rheumatology/Allergy

location_facility: Arkansas Children's Hospital Research Institute

location_facility: Hackensack University Medical Center; Pediatric Rheumatology

location_facility: Universidade Federal de Sao Paulo - UNIFESP

location_facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez; Pediatria

location_facility: Alder Hey Children's NHS Foundation Trust

location_facility: Hospital das Clinicas - FMUSP Ribeirao Preto; Pediatria - Imunologia e Reumatologia

location_facility: Hospital Ramon y Cajal ; Servicio de Reumatologia

location_facility: Cincinnati Children'S Hospital Medical Center; Division of Rheumatology

location_facility: Hospital Infantil Universitario Niño Jesus, Servicio Reumatologia

location_facility: Westmead Hospital; Paediatric Rheumatology

location_facility: Asklepios Klinik; Zentrum fuer Allgemeine Paediatrie und Neonatologie

location_facility: Connecticut Children's Medical Center; 5E Clinical Trials Unit

location_facility: Uniklinikum Freiburg Zentrum für Kinder- und Jugendmedizin; Pädiatrische Infektio- u. Rheumatologie

location_facility: Hospital Infantil de México "Federico Gomez"; Rheumatology

location_facility: Irccs Ospedale Pediatrico Bambin Gesu - Dip. Di Medicina


title: A Phase Ib, Open-Label, Multicenter Study to Investigate the Pharmacokinetics, Pharmacodynamics, and Safety of Tocilizumab Following Subcutaneous Administration to Patients With Polyarticular Juvenile Idiopathic Arthritis

acronym: JIGSAW 117

summary: This open-label, multicenter study evaluated the pharmacokinetics, pharmacodynamics and safety of SC administered TCZ in participants with pJIA.


status: Active, not recruiting

acronym: PURSUIT PEDS PK

title: A Phase 1b Open-Label Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human Anti-TNFα Antibody, in Pediatric Subjects With Moderately to Severely Active Ulcerative Colitis

study_completion_date_type: Anticipated

lead_sponsor: Janssen Research & Development, LLC

location_country:
Denmark
Poland
Austria
Netherlands
Canada
United States
France
Israel
Belgium
Germany

summary: The purpose of this study is to evaluate the pharmacokinetics (what the body does to the study medication) and safety of subcutaneously (under the skin) administered golimumab in pediatric participants (aged 2 to 17 years) with moderately to severely active Ulcerative Colitis (UC).

status_simplified: Ongoing


acronym: The DIVERSITY study

title: Open-label, Randomized, Parallel-group, Active-controlled, Multi-centre Non-inferiority Study of Dabigatran Etexilate Versus Standard of Care for Venous Thromboembolism Treatment in Children From Birth to Less Than 18 Years of Age

lead_sponsor: Boehringer Ingelheim

ReferenceCitation: Brandão LR, Tartakovsky I, Albisetti M, Halton J, Bomgaars L, Chalmers E, Luciani M, Saracco P, Felgenhauer J, Lvova O, Simetzberger M, Sun Z, Mitchell LG. Dabigatran in the treatment and secondary prophylaxis of venous thromboembolism in children with thrombophilia. Blood Adv. 2022 Nov 22;6(22):5908-5923. doi: 10.1182/bloodadvances.2021005681.

ReferenceCitation: Halton J, Brandão LR, Luciani M, Bomgaars L, Chalmers E, Mitchell LG, Nurmeev I, Sharathkumar A, Svirin P, Gorbatikov K, Tartakovsky I, Simetzberger M, Huang F, Sun Z, Kreuzer J, Gropper S, Reilly P, Brueckmann M, Albisetti M; DIVERSITY Trial Investigators. Dabigatran etexilate for the treatment of acute venous thromboembolism in children (DIVERSITY): a randomised, controlled, open-label, phase 2b/3, non-inferiority trial. Lancet Haematol. 2021 Jan;8(1):e22-e33. doi: 10.1016/S2352-3026(20)30368-9. Epub 2020 Dec 5.

ReferenceCitation: Albisetti M, Biss B, Bomgaars L, Brandão LR, Brueckmann M, Chalmers E, Gropper S, Harper R, Huang F, Luciani M, Manastirski I, Mitchell LG, Tartakovsky I, Wang B, Halton JML. Design and rationale for the DIVERSITY study: An open-label, randomized study of dabigatran etexilate for pediatric venous thromboembolism. Res Pract Thromb Haemost. 2018 Mar 25;2(2):347-356. doi: 10.1002/rth2.12086. eCollection 2018 Apr.

location_country:
Spain
Italy
Lithuania
Ukraine
United States
Belgium
Czechia
Austria
Russian Federation
Argentina
Israel
Turkey
Mexico
Norway
Sweden
Brazil
Canada
Switzerland
Hungary
Germany
Denmark
Taiwan
Greece
Finland
Thailand
France

location_facility: HMCP - Hospital e Maternidade Celso Pierro - PUC-Campinas

location_facility: Rigshospitalet, København, Børneonkologisk Afsnit 5002

location_facility: Hospital Infantil Universitario Niño Jesus

location_facility: Reg Clin.Hosp.#1,Healthcare Tyumen Region,Cardiovas.Surgery

location_facility: University of Iowa Hospitals and Clinics

location_facility: Hospital Universitario Dr Jose Eleuterio Gonzalez

location_facility: Hospital General de Niños Pedro de Elizalde

location_facility: PenSI - Pesquisa e Ensino em Saude Infantil

location_facility: Children Intensive Care Hosp,Anaesthesiology Dept,Vilnius

location_facility: Oslo Universitetssykehus HF, Rikshospitalet

location_facility: University Hospital Plzen, Plzen-Lochotin

location_facility: Shaare Zedek Medical Center, Jerusalem 91031

location_facility: Izmilovskaya Child City ClinHosp,Haematological Dept, Moscow

location_facility: Child.CityClin.Hos.na.ZA Bashlyaeva MoscowHealth Dep,Cardiol

location_facility: St.Petersburg State Pediatric Univ.Ministry of Healthcare RF

location_facility: Ege Universitesi Tip Fakultesi Cocuk Hematolojisi Bilim Dali

location_facility: Necmettin Erbakan Universitesi Meram Tip Fakultesi

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi

location_facility: Children Rep.Clin.Hosp of MoH,Cardio Vas.surgery Dept, Kazan

location_facility: Instituto de Crianca / Hospital das Clínicas-FMUSP

location_facility: Science Res.Instit.CV Diseases,Scientific Res.Dept,Kemerovo

location_facility: Istanbul Saglik Bilimleri Uni. Kanuni Sultan Suleyman EAH

location_facility: Cukurova Universitesi Tip Fakultesi Cocuk Sagligi

location_facility: Providence Sacred Heart Medical Center and Children's Hospital

location_facility: Faculdade de Ciencias Medicas da UNICAMP

summary: The main objectives of this large phase IIb/III paediatric study are to assess the efficacy and safety of dabigatran etexilate relative to standard of care and to document the appropriateness of the proposed dabigatran etexilate dosing algorithm for use in patients from birth to less than 18 years of age.


title: Randomized, Double-blind, Placebo-controlled, Multicenter, Phase IIb Dose Finding Study of GLPG0634 Administered for 24 Weeks in Combination With Methotrexate to Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Alone

summary:
Participants suffering from active rheumatoid arthritis despite continued treatment with methotrexate were evaluated for improvement of disease activity (efficacy) when taking GLPG0634 (3 different doses - 50 milligram [mg], 100 mg and 200 mg daily -, each evaluated as once daily [QD] and twice daily [BID] regimen) or matching placebo for 24 weeks.

•During the course of the study, patients were also examined for any side effects that could occur (safety and tolerability), and the amount of GLPG0634 present in the blood (Pharmacokinetics) as well as the effects of GLPG0634 on disease- and mechanism of action-related parameters in the blood (Pharmacodynamics) were determined. Also, the effects of different doses and dose regiments of GLPG0634 administration on participants' disability, fatigue, and quality of life were evaluated.

ReferenceCitation: Combe B, Besuyen R, Gómez-Centeno A, Matsubara T, Sancho Jimenez JJ, Yin Z, Buch MH. Geographic Analysis of the Safety and Efficacy of Filgotinib in Rheumatoid Arthritis. Rheumatol Ther. 2022 Oct 7. doi: 10.1007/s40744-022-00494-1. [Epub ahead of print]

ReferenceCitation: Tarrant JM, Galien R, Li W, Goyal L, Pan Y, Hawtin R, Zhang W, Van der Aa A, Taylor PC. Filgotinib, a JAK1 Inhibitor, Modulates Disease-Related Biomarkers in Rheumatoid Arthritis: Results from Two Randomized, Controlled Phase 2b Trials. Rheumatol Ther. 2020 Mar;7(1):173-190. doi: 10.1007/s40744-019-00192-5. Epub 2020 Jan 7.

ReferenceCitation: Westhovens R, Taylor PC, Alten R, Pavlova D, Enríquez-Sosa F, Mazur M, Greenwald M, Van der Aa A, Vanhoutte F, Tasset C, Harrison P. Filgotinib (GLPG0634/GS-6034), an oral JAK1 selective inhibitor, is effective in combination with methotrexate (MTX) in patients with active rheumatoid arthritis and insufficient response to MTX: results from a randomised, dose-finding study (DARWIN 1). Ann Rheum Dis. 2017 Jun;76(6):998-1008. doi: 10.1136/annrheumdis-2016-210104. Epub 2016 Dec 19.

lead_sponsor: Galapagos NV

location_country:
Spain
Ukraine
United States
Belgium
Czechia
Poland
Austria
Australia
Russian Federation
Argentina
Israel
Mexico
Guatemala
Hungary
Germany
Bulgaria
Moldova, Republic of
Latvia
New Zealand
France
Chile
Colombia

location_facility: Centro de Estudios de Investigacion Basica y Clinica, SC

location_facility: Powiatowy Zakrad Opieki Zdrowotnej w Starachowicach

location_facility: "Multiprofile Hospital for Active Treatment - Kaspela" LTD

location_facility: Instituto Terapias Oncologicas Providencia

location_facility: Central regional polyclinic of Pechersk District

location_facility: National Transport Hospital "Tsar Boris" III

location_facility: Diagnostic Consultative Center "Sveta Anna" LTD

location_facility: Ambulance Revmatologie a Interniho Lekarstvi

location_facility: Instituto de Asistencia Reumatologia Integral

location_facility: Centro Integral de Reumatologia e Inmunologia SAS

location_facility: Wojewodzki Szpital Specjalistyczny we Wroclawiu

location_facility: Rheumatology Associates of North Alabama, PC

location_facility: Complejo Hospitalario Universitario A Coruña

location_facility: Hospital Regional "Guillermo Grant Benavente"

location_facility: State University of Medicine and Dentistry

location_facility: Centro de Alta Especialidad en Reumatología e Investigación del Potosí, S.C.

location_facility: Center for Innovative TherapyDivision of Rheumatology, UCSD

location_facility: Medical University/ AKH Vienna/ Dep.of Rheumatology 6J

location_facility: Artho Care, Arthritis Care & Research P.C.

location_facility: Municipal Institution Lutsk City Clinical Hospital

location_facility: Central Outpatient Hospital of Deanyanskyy Distric

location_facility: Bekes Megyei Pandy Kalman Korhaz, Reumatologiai Osztaly

location_facility: I.M. Sechenov First Moscow State Medical University

location_facility: Centro Integral de Reumatologia de Caribe

location_facility: Fundación del caribe para la investigación medica Fundación BIOS

location_facility: Centro de Investigacion Clínica del Sur Freire

location_facility: V. Gusak Institute of Urgent and Recovery Surgery

location_facility: Charite Mitte, Rheumatologie Neue Therapien

location_facility: Arizona Arthritis & Rheumatology Research PLLC

location_facility: Schlossparkklinik - Akad. Lehrkrankenhaus Charite

location_facility: Clinica Medica Especializada en Reumatologia


title: A Randomized Study Comparing the Safety and Efficacy of the InnFocus MicroShunt® Glaucoma Drainage System to Standard Trabeculectomy In Subjects With Primary Open Angle Glaucoma

acronym: IMS

summary: Assess the safety and effectiveness of the InnFocus MicroShunt when used to lower intraocular pressure (IOP) in subjects with primary open angle glaucoma where the IOP is not controlled when using maximum tolerated glaucoma medications.

ReferenceCitation: Baker ND, Barnebey HS, Moster MR, Stiles MC, Vold SD, Khatana AK, Flowers BE, Grover DS, Strouthidis NG, Panarelli JF; INN005 Study Group. Ab-Externo MicroShunt versus Trabeculectomy in Primary Open-Angle Glaucoma: One-Year Results from a 2-Year Randomized, Multicenter Study. Ophthalmology. 2021 Dec;128(12):1710-1721. doi: 10.1016/j.ophtha.2021.05.023. Epub 2021 May 27.

lead_sponsor: InnFocus Inc.

location_country:
Spain
Italy
United Kingdom
United States
France
Netherlands

location_facility: Ophthalmic Surgeons and Consultants of Ohio

location_facility: Rashid, Rice, Flynn and Reilley Eye Associates

location_facility: Glaucoma Consultants of the Capital Region

location_facility: Chicago Glaucoma Consultants and CGC Eye Center

location_facility: New York Eye and Ear Infirmary of Mt. Sinai

location_facility: University of California at Davis Eye Center

location_facility: Pole Ophtalmologique de la Clinique Mutualiste


acronym: tnAcity

title: A Phase 2/3, Multi-Center, Open-Label, Randomized Study of Weekly Nab®-Paclitaxel in Combination With Gemcitabine or Carboplatin, Compared to Gemcitabine/Carboplatin, as First Line Treatment in Subjects With ER, PgR, and HER2 Negative (Triple Negative) Metastatic Breast Cancer

lead_sponsor: Celgene

ReferenceCitation: Yardley DA, Brufsky A, Coleman RE, Conte PF, Cortes J, Glück S, Nabholtz JM, O'Shaughnessy J, Beck RM, Ko A, Renschler MF, Barton D, Harbeck N. Phase II/III weekly nab-paclitaxel plus gemcitabine or carboplatin versus gemcitabine/carboplatin as first-line treatment of patients with metastatic triple-negative breast cancer (the tnAcity study): study protocol for a randomized controlled trial. Trials. 2015 Dec 16;16:575. doi: 10.1186/s13063-015-1101-7. Erratum in: Trials. 2016;17:63.

ReferenceCitation: Liu MC, Janni W, Georgoulias V, Yardley DA, Harbeck N, Wei X, McGovern D, Beck R. First-Line Doublet Chemotherapy for Metastatic Triple-Negative Breast Cancer: Circulating Tumor Cell Analysis of the tnAcity Trial. Cancer Manag Res. 2019 Dec 12;11:10427-10433. doi: 10.2147/CMAR.S208712. eCollection 2019.

location_country:
Brazil
Portugal
Spain
Greece
Austria
Australia
Italy
Canada
United Kingdom
United States
France
Germany

location_facility: The Center for Cancer and Blood Disorders

location_facility: Hospital de Base Da Faculdade de Medicina de

location_facility: Fundacao Pio XII - Hospital de Cancer de Barretos

location_facility: Schwerpunktpraxis fur Gynakologische Onkologie

location_facility: Hospital das Clinicas da Faculdade de Medicina da USP

location_facility: Hospital Albert Einstein Sociedade Beneficente Israelita Brasileira

location_facility: Azienda Ospedaliero-Universitaria di Ferrara Arcispedale Sant' Anna

location_facility: University of California San Diego Moores Cancer Center

location_facility: University of South Alabama Mitchell Cancer Institute

location_facility: Associacao Hospitalar Moinhos de Vento Hospital Moinhos de Vento

location_facility: Cancer Care Centers of South Texas - Loop

location_facility: Azienda Ospedaliera Citta della Salute e della Scienza di Torino

location_facility: Alan Blair Cancer Centre at Pasqua Hosptial

location_facility: Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: Sociedade Beneficente de Senhoras Hospital Sirio Libanes

location_facility: Chattanooga Oncology Hematology Associates

location_facility: Investigative Clinical Research of Indiana, LLC

location_facility: Joliet Oncology-Hematology Associates, Ltd

location_facility: Facharztpraxis fur Gynakologie und Geburtshilfe

location_facility: Hospital Dr. Amaral Carvalho/ Hospital Amaral Carvalho Jaú

location_facility: Salzburger Landkliniken St. Johanns-Spital

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust

location_facility: Onkologikoa - Kutxaren Institutu Onkologikoa

location_facility: Central Coast Medical Oncology Corporation

location_facility: Center for Cancer and Blood Disorders, PC

location_facility: Hospital Clinico Universitario de Santiago

location_facility: Instituto Ribeiraopretano de Combate Ao Cancer

location_facility: Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi

location_facility: Krankenanstalt Mutterhaus der Borromaerinnen

location_facility: IRCCS AziendaOspedaliera Universitaria San Martino

location_facility: Praxis fur interdisziplinare Onkologie & Hamatologie

location_facility: Instituto Portugues de Oncologia do Porto, Francisco Gentil

location_facility: California Cancer Associates for Research and Excellence cCARE

location_facility: Azienda Ospedaliera Ospedali Riuniti Papardo-Piemonte

location_facility: Dartmouth Hitchcock Medical Center Norris Cotton Cancer Center

location_facility: Henry Ford Medical Center - New Center One

location_facility: The East and North Hertfordshire NHS Trust

location_facility: University General Hospital of Heraklion

location_facility: Hematology Oncology Associates of Fredericksburg

location_facility: Northwest Cancer Specialists, P.C. - Hoyt

location_facility: University of Athens Medical school - Regional General Hospital

location_facility: Hospital du Saint Scarement Sacrement Laboratory

location_facility: Instituto Brasileiro de Controle Do Cancer IBCC

summary: The purpose of this study is to compare the safety and efficacy of nab-paclitaxel in combination with either gemcitabine or carboplatin to the combination of gemcitabine and carboplatin as first line treatment in female subjects with triple negative metastatic breast cancer (TNMBC) or metastatic triple negative breast cancer.


title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Of The Efficacy And Safety Of 2 Doses Of Tofacitinib (CP-690,550) Or Adalimumab In Subjects With Active Psoriatic Arthritis

acronym: OPAL BROADEN

summary: This is a 12-month study investigating the effectiveness and safety of tofactinib in treating the signs and symptoms of active psoriatic arthritis and improving physical function and preserving bone structure in patients with an inadequate response to a traditional, nonbiologic disease-modifying antirheumatic drug. Adalimumab is used as a comparator.

ReferenceCitation: de Vlam K, Mease PJ, Bushmakin AG, Fleischmann R, Ogdie A, Azevedo VF, Merola JF, Woolcott J, Cappelleri JC, Fallon L, Taylor PC. Identifying and Quantifying the Role of Inflammation in Pain Reduction for Patients With Psoriatic Arthritis Treated With Tofacitinib: A Mediation Analysis. Rheumatol Ther. 2022 Oct;9(5):1451-1464. doi: 10.1007/s40744-022-00482-5. Epub 2022 Sep 8.

ReferenceCitation: Orbai AM, Mease PJ, Helliwell PS, FitzGerald O, Fleishaker DL, Mundayat R, Young P. Effect of tofacitinib on dactylitis and patient-reported outcomes in patients with active psoriatic arthritis: post-hoc analysis of phase III studies. BMC Rheumatol. 2022 Sep 1;6(1):68. doi: 10.1186/s41927-022-00298-4.

ReferenceCitation: Taylor PC, Bushmakin AG, Cappelleri JC, Young P, Germino R, Merola JF, Yosipovitch G. Relationships of dermatologic symptoms and quality of life in patients with psoriatic arthritis: analysis of two tofacitinib phase III studies. J Dermatolog Treat. 2022 Aug;33(5):2614-2620. doi: 10.1080/09546634.2022.2060924. Epub 2022 Apr 11.

ReferenceCitation: Gladman DD, Coates LC, Wu J, Fallon L, Bacci ED, Cappelleri JC, Bushmakin AG, Helliwell PS. Time to response for clinical and patient-reported outcomes in patients with psoriatic arthritis treated with tofacitinib, adalimumab, or placebo. Arthritis Res Ther. 2022 Feb 9;24(1):40. doi: 10.1186/s13075-022-02721-0.

ReferenceCitation: Dikranian A, Gold D, Bessette L, Nash P, Azevedo VF, Wang L, Woolcott J, Shapiro AB, Szumski A, Fleishaker D, Wollenhaupt J. Frequency and Duration of Early Non-serious Adverse Events in Patients with Rheumatoid Arthritis and Psoriatic Arthritis Treated with Tofacitinib. Rheumatol Ther. 2022 Apr;9(2):411-433. doi: 10.1007/s40744-021-00405-w. Epub 2021 Dec 17.

ReferenceCitation: Winthrop KL, Curtis JR, Yamaoka K, Lee EB, Hirose T, Rivas JL, Kwok K, Burmester GR. Clinical Management of Herpes Zoster in Patients With Rheumatoid Arthritis or Psoriatic Arthritis Receiving Tofacitinib Treatment. Rheumatol Ther. 2022 Feb;9(1):243-263. doi: 10.1007/s40744-021-00390-0. Epub 2021 Dec 6.

ReferenceCitation: Kivitz AJ, FitzGerald O, Nash P, Pang S, Azevedo VF, Wang C, Takiya L. Efficacy and safety of tofacitinib by background methotrexate dose in psoriatic arthritis: post hoc exploratory analysis from two phase III trials. Clin Rheumatol. 2022 Feb;41(2):499-511. doi: 10.1007/s10067-021-05894-2. Epub 2021 Sep 12.

ReferenceCitation: de Vlam K, Ogdie A, Bushmakin AG, Cappelleri JC, Fleischmann R, Taylor PC, Azevedo V, Fallon L, Woolcott J, Mease PJ. Median time to pain improvement and the impact of baseline pain severity on pain response in patients with psoriatic arthritis treated with tofacitinib. RMD Open. 2021 Jul;7(2). pii: e001609. doi: 10.1136/rmdopen-2021-001609.

ReferenceCitation: Coates LC, Bushmakin AG, FitzGerald O, Gladman DD, Fallon L, Cappelleri JC, Hsu MA, Helliwell PS. Relationships between psoriatic arthritis composite measures of disease activity with patient-reported outcomes in phase 3 studies of tofacitinib. Arthritis Res Ther. 2021 Mar 26;23(1):94. doi: 10.1186/s13075-021-02474-2.

ReferenceCitation: Ritchlin CT, Giles JT, Ogdie A, Gomez-Reino JJ, Helliwell P, Young P, Wang C, Wu J, Romero AB, Woolcott J, Stockert L. Tofacitinib in Patients With Psoriatic Arthritis and Metabolic Syndrome: A Post hoc Analysis of Phase 3 Studies. ACR Open Rheumatol. 2020 Oct;2(10):543-554. doi: 10.1002/acr2.11166. Epub 2020 Sep 10.

ReferenceCitation: Panaccione R, Isaacs JD, Chen LA, Wang W, Marren A, Kwok K, Wang L, Chan G, Su C. Characterization of Creatine Kinase Levels in Tofacitinib-Treated Patients with Ulcerative Colitis: Results from Clinical Trials. Dig Dis Sci. 2021 Aug;66(8):2732-2743. doi: 10.1007/s10620-020-06560-4. Epub 2020 Aug 20. Erratum in: Dig Dis Sci. 2020 Oct 10;:.

ReferenceCitation: Burmester GR, Curtis JR, Yun H, FitzGerald O, Winthrop KL, Azevedo VF, Rigby WFC, Kanik KS, Wang C, Biswas P, Jones T, Palmetto N, Hendrikx T, Menon S, Rojo R. An Integrated Analysis of the Safety of Tofacitinib in Psoriatic Arthritis across Phase III and Long-Term Extension Studies with Comparison to Real-World Observational Data. Drug Saf. 2020 Apr;43(4):379-392. doi: 10.1007/s40264-020-00904-9.

ReferenceCitation: Gladman DD, Charles-Schoeman C, McInnes IB, Veale DJ, Thiers B, Nurmohamed M, Graham D, Wang C, Jones T, Wolk R, DeMasi R. Changes in Lipid Levels and Incidence of Cardiovascular Events Following Tofacitinib Treatment in Patients With Psoriatic Arthritis: A Pooled Analysis Across Phase III and Long-Term Extension Studies. Arthritis Care Res (Hoboken). 2019 Oct;71(10):1387-1395. doi: 10.1002/acr.23930.

ReferenceCitation: Cella D, Wilson H, Shalhoub H, Revicki DA, Cappelleri JC, Bushmakin AG, Kudlacz E, Hsu MA. Content validity and psychometric evaluation of Functional Assessment of Chronic Illness Therapy-Fatigue in patients with psoriatic arthritis. J Patient Rep Outcomes. 2019 May 20;3(1):30. doi: 10.1186/s41687-019-0115-4.

ReferenceCitation: van der Heijde D, Gladman DD, FitzGerald O, Kavanaugh A, Graham D, Wang C, Fallon L. Radiographic Progression According to Baseline C-reactive Protein Levels and Other Risk Factors in Psoriatic Arthritis Treated with Tofacitinib or Adalimumab. J Rheumatol. 2019 Sep;46(9):1089-1096. doi: 10.3899/jrheum.180971. Epub 2019 Mar 1.

ReferenceCitation: Strand V, de Vlam K, Covarrubias-Cobos JA, Mease PJ, Gladman DD, Graham D, Wang C, Cappelleri JC, Hendrikx T, Hsu MA. Tofacitinib or adalimumab versus placebo: patient-reported outcomes from OPAL Broaden-a phase III study of active psoriatic arthritis in patients with an inadequate response to conventional synthetic disease-modifying antirheumatic drugs. RMD Open. 2019 Jan 11;5(1):e000806. doi: 10.1136/rmdopen-2018-000806. eCollection 2019.

ReferenceCitation: Cella D, Wilson H, Shalhoub H, Revicki DA, Cappelleri JC, Bushmakin AG, Kudlacz E, Hsu MA. Content validity and psychometric evaluation of Functional Assessment of Chronic Illness Therapy-Fatigue in patients with psoriatic arthritis. J Patient Rep Outcomes. 2019 Jan 24;3(1):5. doi: 10.1186/s41687-019-0094-5. Corrected and republished in: J Patient Rep Outcomes. 2019 May 20;3(1):30. Retraction in: J Patient Rep Outcomes. 2019 May 28;3(1):32.

RetractionSource: J Patient Rep Outcomes. 2019 May 28;3(1):32

ReferenceCitation: Nash P, Coates LC, Fleischmann R, Papp KA, Gomez-Reino JJ, Kanik KS, Wang C, Wu J, Menon S, Hendrikx T, Ports WC. Efficacy of Tofacitinib for the Treatment of Psoriatic Arthritis: Pooled Analysis of Two Phase 3 Studies. Rheumatol Ther. 2018 Dec;5(2):567-582. doi: 10.1007/s40744-018-0131-5. Epub 2018 Nov 9.

ReferenceCitation: Helliwell P, Coates LC, FitzGerald O, Nash P, Soriano ER, Elaine Husni M, Hsu MA, Kanik KS, Hendrikx T, Wu J, Kudlacz E. Disease-specific composite measures for psoriatic arthritis are highly responsive to a Janus kinase inhibitor treatment that targets multiple domains of disease. Arthritis Res Ther. 2018 Oct 29;20(1):242. doi: 10.1186/s13075-018-1739-0.

ReferenceCitation: Mease P, Hall S, FitzGerald O, van der Heijde D, Merola JF, Avila-Zapata F, Cieślak D, Graham D, Wang C, Menon S, Hendrikx T, Kanik KS. Tofacitinib or Adalimumab versus Placebo for Psoriatic Arthritis. N Engl J Med. 2017 Oct 19;377(16):1537-1550. doi: 10.1056/NEJMoa1615975.

ipd_sharing_description:
Information relating to our policy on data sharing and the process for requesting data can be found at the following link:

http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests

lead_sponsor: Pfizer

location_country:
Poland
Taiwan
Spain
United Kingdom
Russian Federation
Australia
Mexico
Canada
Hungary
United States
France
Belgium
Germany
Bulgaria
Slovakia
Czechia

location_facility: Klinika Ambroziak Estederm Sp. z o.o. ,S.K.A

location_facility: University Hospital Leuven, Department of Rheumatology

location_facility: Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan

location_facility: Hospital Star Medica Merida (For Emergencies Only)

location_facility: Revmatologicky Ustav - Lekarna (pharmacy only)

location_facility: Hopital Erasme - Clinique Universitaire de Bruxelles

location_facility: Przychodnia Specjalistyczna Lekarskiej Spoldzielni Pracy "Medica"

location_facility: Instituto Medico Panamericano, S.A. de C.V. (For Emergencies Only)

location_facility: Prywatna Praktyka Lekarska Prof. UM dr hab. Pawel Hrycaj

location_facility: ROMJAN s.r.o., Reumatologicka ambulancia

location_facility: State Budget Educational Institution of Highest Professional Education

location_facility: Chang Gung Medical Foundation-Kaohsiung Branch

location_facility: Rheumatology Associates of North Alabama, PC

location_facility: State Institution of Healthcare "Regional Clinical Hospital"

location_facility: Centre Hospitalier Sud-Francilien - Secretariat de Rhumatologie

location_facility: MC "New rehabilitation center" EOOD, Rheumatology Cabinet

location_facility: Csolnoky Ferenc Korhaz, Radiologiai Osztaly X-Ray Only

location_facility: Paramount Medical Research & Consulting, LLC

location_facility: NZOZ Centrum Reumatologiczne Indywidualna Specjalistyczna Praktyka Lekarska Lek. Med. Barbara Bazela

location_facility: Investigational Drug Service Pharmacy, Swedish Medical Center.

location_facility: Dartmouth-Hitchcock Medical Center (DHMC)

location_facility: State Budgetary Institution of Healthcare of Moscow City Clinical Hospital

location_facility: Centro de Investigacion Clinica Pensiones

location_facility: Barking Havering and Redbridge University Hospital NHS Trust-King George Hospital

location_facility: Regional State Budgetary Healthcare Institution of Karelia Republic

location_facility: Synexus Polska Sp. z o.o. Oddz. we Wroclawiu

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej Przychodnia Chirurgiczna dla Dzieci "PriamaMed" Sp.P.,"

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Complexo Hospitalario Universitario A Coruna

location_facility: ZDROWIE OSTEO-MEDIC s.c. L. i A. Racewicz, A. i J. Supronik

location_facility: Hospital Universitario y Politecnico La Fe

location_facility: Bradford Teaching Hospitals NHS Foundation Trust

location_facility: Sanatorio CEMSI Chapultepec (For Emergencies Only)

location_facility: State Healthcare Institution of Yaroslavl Region Clinical Emergency Hospital n.a. N.V. Solovyev

location_facility: Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy,

location_facility: Investigacion y Biomedicina de Chihuahua SC

location_facility: MEDMAN s.r.o. - reumatologicka ambulancia

location_facility: Dynacare Laboratories (Specimen processing for shipment)

location_facility: State Institution of Healthcare of Yaroslavl Region

location_facility: Drug Shipment/Storage: Huntsman Cancer Hospital at the University of Utah

location_facility: Unidad Reumatologica Las Americas, S.C.P.

location_facility: Wirral University Teaching Hospital NHS Foundation Trust

location_facility: York Teaching Hospital NHS Foundation Trust

location_facility: Limited Liability Company Consultative Diagnostic Rheumatology Center "Healthy Joints"

location_facility: Arizona Arthritis & Rheumatology Associates, P.C.

location_facility: ClinicMed Badurski i wspolnicy Spolka Jawna

location_facility: NZOZ Nasz Lekarz Praktyka Grupowa Lekarzy Rodzinnych z Przychodnia Specjalistyczna w Toruniu

location_facility: West Island Rheumatology Research Associates

location_facility: Magyar Honvedseg Egeszsegugyi Kozpont,Reumatologiai osztaly

location_facility: Hospital General de Culiacán Dr. Bernardo J. Gastélum

location_facility: Zespol Poradni Specjalistycznych Reumed Filia Onyksowa

location_facility: Centro Integral en Reumatologia SA de CV

location_facility: Centrum Kliniczno-Badawcze J.Brzezicki, B.Gornikiewicz-Brzezicka Lekarze Spolka Partnerska

location_facility: Centro de Investigacion de Tratamientos Innovadores de Sinaloa, S.C.

location_facility: Barking, Havering and Redbridge University Hospitals NHS Trust

location_facility: HOSPITAL STAR MEDICA S.A DE C.V- (emergencies only)

location_facility: OOO City Neurological Centre "Sibneiromed"

location_facility: Csolnoky Ferenc Korhaz, Reumatologiai Osztaly

location_facility: Medical Plus s.r.o. Lekarna Hradebni s. r.o


ipd_sharing: No

title: A Phase Ib Trial of LEE011 in Combination With Everolimus (RAD001) and Exemestane in the Treatment of Postmenopausal Women With Hormone Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer

location_country:
Hong Kong
Spain
United States
France
Belgium

location_facility: Oregon Health and Science University SC-5

location_facility: University of Texas MD Anderson Cancer Center Onc Dept

location_facility: Sylvester Comprehensive Cancer Center Main Center

summary:
Dose Escalation part of the study: To estimate the MTD(s) and/ or RP2D of LEE011 in combination with everolimus + exemestane, and LEE011 in combination with exemestane, and to characterize the safety and tolerability of the combinations of everolimus + exemestane + LEE011 and LEE011 + exemestane in patients with ER+ HER2- advanced breast cancer

Dose Expansion part of the study: To characterize the safety and tolerability of the triplet combination of LEE011 + everolimus + exemestane in patients naïve or refractory to CDK4/6 inhibitor based therapy, and the safety and tolerability of the doublet combination of LEE011 + exemestane in patients refractory to CDK4/6 inhibitor based therapy (except patients treated with prior LEE011 are not allowed in Group 3).


title: A Multicenter, Parallel-group Study of Long-term Safety and Efficacy of CNTO 136 (Sirukumab) for Rheumatoid Arthritis in Subjects Completing Treatment in Studies CNTO136ARA3002 (SIRROUND-D) and CNTO136ARA3003 (SIRROUND-T)

acronym: SIRROUND-LTE

summary: The purpose of this study is to evaluate the long-term safety and efficacy of CNTO 136 (sirukumab) in participants with rheumatoid arthritis (RA) who are unresponsive to treatment with modifying antirheumatic drugs (DMARDs) or anti-TNF alpha agents.

ReferenceCitation: Aletaha D, Bingham CO, Karpouzas GA, Takeuchi T, Thorne C, Bili A, Agarwal P, Hsu B, Rao R, Brown K, Tanaka Y. Long-term safety and efficacy of sirukumab for patients with rheumatoid arthritis who previously received sirukumab in randomised controlled trials (SIRROUND-LTE). RMD Open. 2021 Jan;7(1). pii: e001465. doi: 10.1136/rmdopen-2020-001465.

location_country:
Croatia
Serbia
Spain
United Kingdom
Lithuania
Ukraine
United States
Belgium
Japan
Romania
South Africa
Poland
Portugal
Austria
Australia
Russian Federation
Argentina
Puerto Rico
Mexico
Malaysia
Canada
Germany
Bulgaria
Taiwan
Korea, Republic of
France
Chile
Colombia
Netherlands


title: An Open-label, Multicenter Protocol Providing Pegylated Interferon Alfa-2a (Pegasys®) as Monotherapy or in Combination With Ribavirin (Copegus®) for Patients With Chronic Hepatitis C Who Have Participated in Previous Roche or Roche Partner Protocols

summary: This open-label, non-randomized, single arm study will provide treatment or re-treatment with Pegasys (peginterferon alfa-2a) as monotherapy or in combination with Copegus (ribavirin) to patients with chronic hepatitis C infection. Patients who have received prior Pegasys monotherapy or combination therapy or who were considered eligible for treatment with Pegasys in previous donor protocols will be eligible to participate in this study. Treatment will be on investigator's decision according to the approved label for up to 48 weeks, with a 24-week safety follow-up.

location_country:
Poland
Taiwan
Brazil
Spain
Greece
Italy
Australia
United Kingdom
Puerto Rico
United States
France


ipd_sharing: Undecided

title: Double Blind, Placebo Controlled Study Assessing the Efficacy of Buparlisib (BKM120) Plus Paclitaxel Versus Placebo Plus Paclitaxel in Patients With Platinum Pre-treated Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)

ReferenceCitation: Soulières D, Faivre S, Mesía R, Remenár É, Li SH, Karpenko A, Dechaphunkul A, Ochsenreither S, Kiss LA, Lin JC, Nagarkar R, Tamás L, Kim SB, Erfán J, Alyasova A, Kasper S, Barone C, Turri S, Chakravartty A, Chol M, Aimone P, Hirawat S, Licitra L. Buparlisib and paclitaxel in patients with platinum-pretreated recurrent or metastatic squamous cell carcinoma of the head and neck (BERIL-1): a randomised, double-blind, placebo-controlled phase 2 trial. Lancet Oncol. 2017 Mar;18(3):323-335. doi: 10.1016/S1470-2045(17)30064-5. Epub 2017 Jan 26.

location_country:
Poland
Taiwan
Spain
Ireland
Italy
Australia
Russian Federation
Canada
Thailand
Switzerland
United Kingdom
Hungary
Korea, Republic of
United States
France
India
Japan
Germany

location_facility: Washington U School of Medicine Center for Clinical Studies SC - BKM120H2201

location_facility: University of N.C. at Chapel Hill Lineberger Comp. Cancer Ctr.

location_facility: The Mount Sinai Hospital Dept of Oncology

location_facility: University Hospitals Case Medical Center Univ. Hospitals of Cleveland

summary: Phase II Study of efficacy and safety of buparlisib (BKM120) plus paclitaxel versus placebo plus paclitaxel in recurrent or metastatic Head and Neck cancer previously pre-treated with a platinum therapy.The primary endpoint was PFS and the key secondary endpoint was Overall Survival.


title: A Phase II, Multicenter, Single-arm Study of MPDL3280A in Patients With PD-L1-Positive Locally Advanced or Metastatic Non-small Cell Lung Cancer

lead_sponsor: Genentech, Inc.

ReferenceCitation: Shemesh CS, Chan P, Legrand FA, Shames DS, Das Thakur M, Shi J, Bailey L, Vadhavkar S, He X, Zhang W, Bruno R. Pan-cancer population pharmacokinetics and exposure-safety and -efficacy analyses of atezolizumab in patients with high tumor mutational burden. Pharmacol Res Perspect. 2020 Dec;8(6):e00685. doi: 10.1002/prp2.685.

location_country:
United Kingdom
United States
France
Belgium
Netherlands

location_facility: Penn Presbyterian Medical Center; Abramson Cancer Center

location_facility: HonorHealth Research Institute - Pima Center

location_facility: Stanford University/Lucile Packard Children's Hospital

location_facility: Penn State Univ. Milton S. Hershey Medical Center; MSHMC Cardiology

location_facility: The University of Chicago Medical Center

location_facility: Huntsman Cancer Institute; University of Utah

location_facility: Dartmouth Hitchcock Med Center; Norris Cotton Cancer Ctr

location_facility: Royal Marsden Hospital - Fulham; Oncology Department

location_facility: The Angeles Clinic and Research Institute, Santa Monica Office

location_facility: Hematology Oncology Associates of the Treasure Coast

location_facility: H. Lee Moffitt Cancer Center and Research Inst.

location_facility: University of Washington Seattle Cancer Care Alliance

location_facility: Carolina BioOncology Institute; Can Therapy & Res Ctr

summary:
This multicenter, single-arm study will evaluate the efficacy and safety of atezolizumab (MPDL3280A) in participants with PD-L1-positive locally advanced or metastatic NSCLC. Participants will receive an intravenous (IV) dose of 1200 milligrams (mg) atezolizumab (MPDL3280A) on Day 1 of 21-day cycles until disease progression.

Eligible participants will be categorized in to three groups as follows:

Participants with no prior chemotherapy for advanced disease;
Participants who progress during or following a prior-platinum based chemotherapy regimen for advanced disease (2L+participants);
Participants who are 2L+ and previously treated for brain metastases.


title: Frailty Assessment Before Cardiac Surgery & Transcatheter Interventions

summary: Frailty is a state of decreased physiologic reserves and vulnerability to stressors. Several tools exist to measure frailty, some based on physical tests and others on questionnaires, yet there is no agreement on which tool to recommend. This multi-center prospective cohort study is aimed at comparing various frailty assessment tools to determine which best predicts death or major complications after cardiac surgery or transcatheter intervention. The population of interest is elderly patients with severe aortic stenosis undergoing surgical or transcatheter aortic valve replacement. The frailty assessment tools under investigation include composite frailty scales, physical performance tests, muscle mass, and biomarker expression. The overall objective is to improve our ability to predict risk by measuring frailty using the optimal tool in elderly cardiovascular patients.

enrollment_type: Anticipated

ReferenceCitation: Shi SM, Sung M, Afilalo J, Lipsitz LA, Kim CA, Popma JJ, Khabbaz KR, Laham RJ, Guibone K, Lee J, Marcantonio ER, Kim DH. Delirium Incidence and Functional Outcomes After Transcatheter and Surgical Aortic Valve Replacement. J Am Geriatr Soc. 2019 Jul;67(7):1393-1401. doi: 10.1111/jgs.15867. Epub 2019 Mar 18.

ReferenceCitation: Afilalo J, Lauck S, Kim DH, Lefèvre T, Piazza N, Lachapelle K, Martucci G, Lamy A, Labinaz M, Peterson MD, Arora RC, Noiseux N, Rassi A, Palacios IF, Généreux P, Lindman BR, Asgar AW, Kim CA, Trnkus A, Morais JA, Langlois Y, Rudski LG, Morin JF, Popma JJ, Webb JG, Perrault LP. Frailty in Older Adults Undergoing Aortic Valve Replacement: The FRAILTY-AVR Study. J Am Coll Cardiol. 2017 Aug 8;70(6):689-700. doi: 10.1016/j.jacc.2017.06.024. Epub 2017 Jul 7.

lead_sponsor: Jewish General Hospital

location_country:
United States
Canada
France

location_facility: Centre Hospitalier Universite de Montreal

lead_sponsor_type: academique


title: A Phase 3, Randomized, Double-Blind, Double-Dummy, Multicenter, Prospective Study to Assess the Efficacy and Safety of Eravacycline Compared With Ertapenem in Complicated Intra-abdominal Infections

summary: This is a Phase 3, randomized, double-blind, double-dummy, multicenter, prospective study to assess the efficacy, safety, and pharmacokinetics of eravacycline compared with ertapenem in the treatment of adult complicated intra-abdominal infections (cIAI).

ReferenceCitation: Solomkin JS, Sway A, Lawrence K, Olesky M, Izmailyan S, Tsai L. Eravacycline: a new treatment option for complicated intra-abdominal infections in the age of multidrug resistance. Future Microbiol. 2019 Oct;14:1293-1308. doi: 10.2217/fmb-2019-0135. Epub 2019 Oct 1.

ReferenceCitation: Solomkin JS, Gardovskis J, Lawrence K, Montravers P, Sway A, Evans D, Tsai L. IGNITE4: Results of a Phase 3, Randomized, Multicenter, Prospective Trial of Eravacycline vs Meropenem in the Treatment of Complicated Intraabdominal Infections. Clin Infect Dis. 2019 Aug 30;69(6):921-929. doi: 10.1093/cid/ciy1029.

ReferenceCitation: Solomkin J, Evans D, Slepavicius A, Lee P, Marsh A, Tsai L, Sutcliffe JA, Horn P. Assessing the Efficacy and Safety of Eravacycline vs Ertapenem in Complicated Intra-abdominal Infections in the Investigating Gram-Negative Infections Treated With Eravacycline (IGNITE 1) Trial: A Randomized Clinical Trial. JAMA Surg. 2017 Mar 1;152(3):224-232. doi: 10.1001/jamasurg.2016.4237.

lead_sponsor: Tetraphase Pharmaceuticals, Inc.

location_country:
Latvia
Russian Federation
Estonia
Argentina
Lithuania
Ukraine
United States
France
South Africa
Romania
Germany
Bulgaria
Czechia


title: An Open Label Study to Assess the Safety and Efficacy of COR-003 (Levoketoconazole) in the Treatment of Endogenous Cushing's Syndrome

acronym: SONICS

summary: The primary objectives of this study are to evaluate the clinical responder rate, defined as the proportion of subjects with normal UFC after 6 months of treatment with COR-003 in the Maintenance Phase without dose increase, and to evaluate the range of effective doses in subjects with various levels of hypercortisolism.

ReferenceCitation: Fleseriu M, Pivonello R, Elenkova A, Salvatori R, Auchus RJ, Feelders RA, Geer EB, Greenman Y, Witek P, Cohen F, Biller BMK. Efficacy and safety of levoketoconazole in the treatment of endogenous Cushing's syndrome (SONICS): a phase 3, multicentre, open-label, single-arm trial. Lancet Diabetes Endocrinol. 2019 Nov;7(11):855-865. doi: 10.1016/S2213-8587(19)30313-4. Epub 2019 Sep 18. Erratum in: Lancet Diabetes Endocrinol. 2019 Nov;7(11):e22.

ReferenceCitation: Geer EB, Salvatori R, Elenkova A, Fleseriu M, Pivonello R, Witek P, Feelders RA, Bex M, Borresen SW, Puglisi S, Biller BMK, Cohen F, Pecori Giraldi F. Levoketoconazole improves clinical signs and symptoms and patient-reported outcomes in patients with Cushing's syndrome. Pituitary. 2021 Feb;24(1):104-115. doi: 10.1007/s11102-020-01103-6. Epub 2020 Nov 20. Erratum in: Pituitary. 2020 Dec 14;:.

ReferenceCitation: Pivonello R, Elenkova A, Fleseriu M, Feelders RA, Witek P, Greenman Y, Geer EB, Perotti P, Saiegh L, Cohen F, Arnaldi G. Levoketoconazole in the Treatment of Patients With Cushing's Syndrome and Diabetes Mellitus: Results From the SONICS Phase 3 Study. Front Endocrinol (Lausanne). 2021 Apr 7;12:595894. doi: 10.3389/fendo.2021.595894. eCollection 2021.

lead_sponsor: Cortendo AB

location_country:
Denmark
Poland
Serbia
Spain
Italy
Netherlands
Canada
United States
France
Israel
Turkey
Belgium
Germany
Bulgaria
Czechia

location_facility: Azienda Ospedaliero - Universitaria Città della Salute e della Scienza di Torino

location_facility: Erasmus MC, Dpt. Of Internal Medicine, Division of Endocrinology

location_facility: St. Pauls Hospital/Vancouver General Hospital

location_facility: Hôpital de la CONCEPTION, Service d'Endocrinologie, Diabète et Maladies Métaboliques

location_facility: University Hospitals Leuven Department of Endocrinology

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1

location_facility: Bnail Zion Medical Center Institute of Endocrinology & Metabolism

location_facility: Institute of Endocrinology & Metabolism, Rabin Medical Center

location_facility: Vseobecna fakultni nemocnice v Praze - III. Interni klinika VFN a 1. LF UK

location_facility: Bezmi Alem Vakıf Üniversitesi Endokrinoloji Bölümü Adnan

location_facility: Sourasky Medical Center, Endocrinology & Metabolism

location_facility: UOC di Endocrinologia, Dipartimento di Medicina Clinica e Sperimentale

location_facility: Leiden University, Leiden University Medical Center, Dept. of Endocrinology

location_facility: University Specialized Hospital for Active Treatment in Endocrinology (USHATE)

location_facility: SCDU Medicina Interna I Università di Torino Dipartimento di Scienze Cliniche e Biologiche

location_facility: Szpital Kliniczny im. Heliodora Swiecickiego

location_facility: Endocrinologia, Hospital Sant Pau,Universitat Autònoma de Barcelona


title: A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group Study of JNJ-38518168 in Symptomatic Adult Subjects With Uncontrolled, Persistent Asthma

summary: The purpose of this study is to evaluate the efficacy, safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of JNJ-38518168 compared with placebo in participants with persistent asthma that is inadequately controlled despite current treatment.

ReferenceCitation: Kollmeier AP, Barnathan ES, O'Brien C, Chen B, Xia YK, Zhou B, Loza MJ, Silkoff PE, Ge M, Thurmond RL. A phase 2a study of toreforant, a histamine H(4) receptor antagonist, in eosinophilic asthma. Ann Allergy Asthma Immunol. 2018 Nov;121(5):568-574. doi: 10.1016/j.anai.2018.08.001. Epub 2018 Aug 11.

location_country:
United Kingdom
Canada
United States
Israel
France
Germany


title: An Open-Label, Single and Repeat Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-17299425 in Patients With Traumatic Brain Injury

lead_sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

location_country: France Belgium

summary: The purpose of this study is to evaluate safety, tolerability, pharmacokinetics (explores what the body does to the drug) and pharmacodynamics (the study of the action or effects a drug has on the body) of JNJ-17299425 in participants with traumatic brain injury (acute and chronic injuries to the brain, including the cerebral hemispheres, cerebellum, and brain stem).


title: International Study for Treatment of Standard Risk Childhood Relapsed ALL 2010 A Randomized Phase III Study Conducted by the Resistant Disease Committee of the International BFM Study Group

summary: The main goal of this study is to improve the outcome of children and adolescents with standard risk (SR) first relapsed acute lymphoblastic leukemia. Furthermore, goal is to set up a large international study group platform allowing for optimization of standard treatment strategies and integration of new agents.

lead_sponsor: Charite University, Berlin, Germany

location_country:
Denmark
Poland
Portugal
United Kingdom
Italy
Austria
Australia
Netherlands
Finland
Switzerland
France
Israel
Norway
Belgium
Japan
Germany
Czechia

location_facility: Dpt. SCT and Hematology/Oncology University Wroclaw

location_facility: Copenhagen University Hospital (Rigshospitalet)

location_facility: Instituto Português de Oncologia de Lisboa

location_facility: Australian & New Zealand Childhood Hematology & Oncology Group

location_facility: Hòpital Universitaire des Enfants Reine Fabiola


title: A Single-Arm, Multicenter, Open-Label, Phase 2 Study of Gemcitabine-Cisplatin Chemotherapy Plus Necitumumab (IMC-11F8) in the First-Line Treatment of Patients With Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC)

summary: The purpose of this study is to see how participants with late stage lung cancer do on gemcitabine-cisplatin chemotherapy plus necitumumab. The study will also see how safe the drugs are in combination and to see how long the medicine stays in the body. The study will last approximately 2 years.

lead_sponsor: Eli Lilly and Company

location_country:
Taiwan
Spain
Canada
United States
France
Mexico
Netherlands

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.


title: A Phase Ib/II, Open-label, Multi-center, Dose-finding Study to Assess the Safety and Efficacy of the Oral Combination of LDE225 and INC424 (Ruxolitinib) in Patients With Myelofibrosis

lead_sponsor: Novartis Pharmaceuticals

ReferenceCitation: Gupta V, Wolleschak D, Hasselbalch H, Vannucchi AM, Koschmieder S, Cervantes F, Li Y, Dong T, Wroclawska M, Bharathy S, Harrison C. Safety and efficacy of the combination of sonidegib and ruxolitinib in myelofibrosis: a phase 1b/2 dose-finding study. Blood Adv. 2020 Jul 14;4(13):3063-3071. doi: 10.1182/bloodadvances.2019001212.

ipd_sharing_description:
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.

location_country:
Denmark
Spain
Ireland
Italy
Australia
Netherlands
Canada
United Kingdom
France
Belgium
Germany

summary: The purpose of this phase Ib/II clinical trial was to: a) evaluate the safety of the co-administration of LDE225 and INC424 in myelofibrosis patients and establish a maximum tolerated dose and/or Recommended Phase II dose of the combination and b) to assess the efficacy of the co-administration of LDE225 and INC424 on spleen volume reduction.


acronym: OCTAVE

title: A 24-month, Phase IIIb, Randomized, Double-masked, Multicenter Study Assessing the Efficacy and Safety of Two Treatment Regimens of 0.5 mg Ranibizumab Intravitreal Injections Guided by Functional and/or Anatomical Criteria, in Patients With Neovascular Age-related Macular Degeneration

ReferenceCitation: Staurenghi G, Garweg JG, Gerendas BS, Macfadden W, Gekkiev B, Margaron P, Dunger-Baldauf C, Kolar P. Functional versus functional and anatomical criteria-guided ranibizumab treatment in patients with neovascular age-related macular degeneration - results from the randomized, phase IIIb OCTAVE study. BMC Ophthalmol. 2020 Jan 9;20(1):18. doi: 10.1186/s12886-019-1251-6.

location_country:
Spain
Italy
United Kingdom
Lithuania
Czechia
Portugal
Austria
Argentina
Turkey
Panama
Mexico
Sweden
Slovakia
Canada
Switzerland
Guatemala
Hungary
Germany
Greece
Ireland
Finland
France
Colombia
Netherlands

summary:
This study will evaluate and compare two individualized ranibizumab treatment regimens in patients with neovascular (wet) AMD aiming to achieve and to maintain a maximum visual function benefit, while aiming to avoid unnecessary intravitreal injections.

The results will be used to generate further recommendations on functional and anatomical monitoring of the disease and timing of treatment administration for patients with neovascular AMD. In this context, the study will investigate the utility of optical coherence tomography (OCT) to aid retreatment decisions with ranibizumab.


title: The Premature Infants Resuscitated With Oxygen or Air (PRESOX) Trial

acronym: PRESOX

summary: The most appropriate initial oxygen concentration for the resuscitation of the extremely low birth weight infant has not been established using large well designed, randomized, blinded, prospective trials and the level of oxygen utilized by practitioners in this situation is highly variable. This proposed trial will use targeted oxygen saturation levels over the first 15 to 20 minutes of life to compare a low and a higher initial oxygen level for the resuscitation of such infants, and will be large enough to evaluate short term outcomes of survival without oxygen at 36 weeks and survival without retinopathy of prematurity, and the long term outcome of survival without significant neurodevelopmental impairment at 2 years of age. Such information is urgently required to provide an evidence basis for the initial oxygen concentration for resuscitation of these very preterm infants.

lead_sponsor: Sharp HealthCare

location_country:
Poland
Slovenia
Ireland
Austria
Italy
Russian Federation
Spain
United Kingdom
Sweden
United States
France
Germany

location_facility: Oklahoma University Health Sciences Center

location_facility: University of Miami Miller School of Medicine

location_facility: Sharp Mary Birch Hospital for Women and Newborns

location_facility: St. Petersberg State Pediatric Medical University

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

intervention_type: Other


title: A Multi-Center, Open-Label, Phase 1/1b Study of Escalating Doses of RO5503781 Administered Orally as 1) a Single Agent, 2) In Combination With Cytarabine, or 3) With Cytarabine and Anthracycline and 4) Assessing PK and Safety of New Optimized Formulation of RO5503781 With Cytarabine in Patients With Acute Myelogenous Leukemia (AML)

summary: This Phase 1/1b, open-label study will evaluate the safety and pharmacokinetics of escalating doses of RO5503781 as a single agent or in combination with cytarabine in participants with acute myelogenous leukemia. In Part 1, RO5503781 will be administered in escalating doses as a single agent, and in Part 2, RO5503781 will be administered in combination with cytarabine. An optional Part 3 in which RO5503781 will be administered with cytarabine and anthracycline may be considered . In Part 4, the safety and pharmacokinetic profile of an optimized formulation of RO5503781 in combination with cytarabine will be assessed.

ReferenceCitation: Yee K, Papayannidis C, Vey N, Dickinson MJ, Kelly KR, Assouline S, Kasner M, Seiter K, Drummond MW, Yoon SS, Lee JH, Blotner S, Jukofsky L, Pierceall WE, Zhi J, Simon S, Higgins B, Nichols G, Monnet A, Muehlbauer S, Ott M, Chen LC, Martinelli G. Murine double minute 2 inhibition alone or with cytarabine in acute myeloid leukemia: Results from an idasanutlin phase 1/1b study⋆. Leuk Res. 2021 Jan;100:106489. doi: 10.1016/j.leukres.2020.106489. Epub 2020 Dec 1.

lead_sponsor: Hoffmann-La Roche

location_country:
United Kingdom
Italy
Australia
Canada
Korea, Republic of
United States
France

location_facility: Institut J Paoli I Calmettes; Onco Hematologie 2

location_facility: Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology

location_facility: The Beatson West of Scotland Cancer Centre; Cancer Clinical Trials Unit

location_facility: Cancer Therapy & Research Ctr; Dept Institute for Drug Development

location_facility: University Health Network; Princess Margaret Hospital; Medical Oncology Dept

location_facility: McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology

location_facility: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpigh


title: A Prospective Natural History Study of Progression of Physical Impairment, Activity Limitation and Quality of Life in Duchenne Muscular Dystrophy.

summary: To characterize the natural history and progression of Duchenne Muscular Dystrophy (DMD) to help inform the design of future studies, to capture biomarkers of safety and disease progression and to provide comparative data for the development of rare exons for which formal controlled trials are not feasible.

lead_sponsor: BioMarin Pharmaceutical

location_country:
Brazil
Italy
Netherlands
Argentina
Sweden
France
United States
Turkey
Belgium
Germany

location_facility: Azienda Ospedaliera Universitaria Policlinico G. Martino

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Policlinico Univsersitario Agostino Gemelli

location_facility: Hospital das Clinicas da Faculdade de Medicina da USP

location_facility: Drottning Silvias Barn- ochungdomssjukhus

location_facility: Hospital de Pediatria Prof Dr Juan P Garrahan


title: Vascutek Anaconda™ Stent Graft System for Infra-Renal Abdominal Aortic Aneurysm Repair

summary: The purpose of this observational Post-Market Surveillance Registry is to gather post-market data on the performance of the CE marked Vascutek Anaconda™ Stent Graft System for the repair of Abdominal Aortic Aneurysms (AAA). The Study population consists of patients suitable for endovascular repair of AAA. Patients will be followed at 1, 3, 6, 12, 18, 24, 36, 48 and 60 months post-implantation.

lead_sponsor: Vascutek Ltd.

location_country:
Spain
Italy
United Kingdom
New Zealand
Australia
France
Germany

location_facility: Hospital Universitario Madrid Monteprincipe

intervention_type: Device


title: An Open-label, Multicenter, Follow-up Study to Evaluate the Long-term Safety and Efficacy of Brivaracetam Used as Adjunctive Treatment in Subjects Aged 16 Years or Older With Epilepsy Phase 3b

summary: N01372 study is to evaluate the long-term safety, tolerability, maintenance of efficacy of Brivaracetam (BRV); as well as the effect of BRV on subjects' health-related quality of life and to explore the direct medical resource use for BRV (for subjects entering N01372 from a study where pharmacoeconomic data was collected). BRV will be used at doses up to maximum of 200 mg/day, as adjunctive treatment in subjects aged 16 years or older with Epilepsy.

ReferenceCitation: Markham A. Brivaracetam: First Global Approval. Drugs. 2016 Mar;76(4):517-22. doi: 10.1007/s40265-016-0555-6. Review.

lead_sponsor: UCB Pharma SA

location_country:
Germany
United States
Spain
France


title: Screening Platform of the EORTC for Clinical Trials in Advanced Colorectal Cancer "SPECTAcolor"

acronym: SPECTAcolor

summary:
The EORTC GastroIntestinal Tract Cancer Group and the EORTC HeadQuarters wish to set up a European screening platform for advanced colo-rectal cancer (CRC) patients. The goal of this screening platform is to provide quick access to new drugs to patients by offering a new structure for clinical trials.

Currently some of the most challenging clinical questions arise from the molecular sub-division of CRC that would theoretically allow to inhibit the specific, altered pathways in the patients.

A major problem for trials in this "personalized medicine" is that the low frequency of the different mutations requires a high effort for screening and identifying the patients.

The EORTC CRC screening platform will hopefully offer a feasible and efficient way to characterize the patients on the molecular basis of their tumors and allow to offer them rapid and preferential participation in clinical studies with new drugs targeted to their specific pathway alterations.

lead_sponsor: European Organisation for Research and Treatment of Cancer - EORTC

location_country: Poland Portugal Spain Greece Italy Switzerland Sweden France Belgium Germany Cyprus

location_facility: Seconda Universita Degli Studi Di Napoli

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: IRCCS Azienda Ospedaliera Universitaria San Martino "IST" Istituto Nazionale per la Ricerca sul Cancro

location_facility: Maria Sklodowska-Curie Memorial Cancer Centre

location_facility: Hôpitaux universitaires de Genève - HUG - site de Cluse-Roseraie

location_facility: Hopitaux Universitaires Bordet-Erasme - Hopital Universitaire Erasme

location_facility: Ludwig-Maximilians-Universitaet Muenchen - Klinikum der Universitaet Muenchen - Campus Grosshadern

location_facility: Hopitaux Universitaires Bordet-Erasme - Institut Jules Bordet

location_facility: Institut Catala d'Oncologia - ICO L'Hospitalet - Hospital Duran i Reynals

location_facility: I.P.O. Francisco Gentil - Centro De Lisboa

intervention_type: Genetic


title: A Phase 2 Exploratory Study of Mavrilimumab Versus Anti-tumor Necrosis Factor in Subjects With Rheumatoid Arthritis

summary: The primary objectives of this study is to explore the efficacy of mavrilimumab compared with golimumab in the treatment of adult subjects 18-80 years of age with moderate-to-severe active rheumatoid arthritis (RA) who have an inadequate response to one or more conventional disease-modifying anti-rheumatic drugs (DMARDs) and/or one or two anti-tumor necrosis factor (TNF) agents (excluding golimumab) for efficacy or safety reasons.

lead_sponsor: MedImmune LLC

location_country:
Portugal
Serbia
Spain
Greece
Russian Federation
Mexico
United Kingdom
Argentina
Czech Republic
Hungary
France
Israel
Colombia
Slovakia