title: TARGIT-C(Consolidation) Prospective Phase IV Study of Intraoperative Radiotherapy (IORT) in Patients With Small Breast Cancer

acronym: TARGIT-C

summary:
This prospective, multicentric single arm phase IV study is based on the protocol of the international TARGIT-A and TARGIT-E study.

Patients ≥ 50 years with small, low-risk breast cancer who are operated but not irradiated show local relapse rates around 6% after 5 years. With adjuvant whole breast radiotherapy (WBRT) the local relapse rate drops to under 1% after 5 years under Tamoxifen (4).

It has been demonstrated (6, 9, 10) that the efficacy of radiation of the tumor bed only in a selected group can be non-inferior to WBRT.

The TARGIT C study should confirm the efficacy of a single dose of intraoperative radiotherapy (IORT) in a well selected group of patients with small breast cancer and absence of risk factors. In presence of risk factors postoperative WBRT will be added to complete the radiotherapeutic treatment according to international guidelines.

Endpoints are the local relapse rate (within 2 cm of the tumor bed), ipsilateral relapse, cancer-specific and overall survival and contralateral breast cancer as well as documentation of quality of life and cosmetic outcome.

The expected local relapse rates are 0.825/1.375% after 3/5 years, respectively. Discontinuation of the trial is scheduled if rates of local relapse rates rise to 1.55/2.4/4% after 1/3/5 years. Power calculations result in 387 patients with a calculated dropout and loss to follow-up rate of 10%, an alpha of 0.05 and a beta of 0.10. There will be only a pre-pathology stratum.

It is a pragmatic trial in which each participating centre has the option to modify entry criteria and criteria for WBRT according to this core protocol after consultation with the steering committee and local ethics committee (e.g. size, free margins). Only centers with access to the Intrabeam® system (Carl Zeiss) can recruit patients into the trial.

ReferenceCitation: Fisher B, Anderson S, Redmond CK, Wolmark N, Wickerham DL, Cronin WM. Reanalysis and results after 12 years of follow-up in a randomized clinical trial comparing total mastectomy with lumpectomy with or without irradiation in the treatment of breast cancer. N Engl J Med. 1995 Nov 30;333(22):1456-61.

ReferenceCitation: Veronesi U, Cascinelli N, Mariani L, Greco M, Saccozzi R, Luini A, Aguilar M, Marubini E. Twenty-year follow-up of a randomized study comparing breast-conserving surgery with radical mastectomy for early breast cancer. N Engl J Med. 2002 Oct 17;347(16):1227-32.

ReferenceCitation: Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: an overview of the randomised trials. Lancet. 2005 May 14-20;365(9472):1687-717.

ReferenceCitation: Fyles AW, McCready DR, Manchul LA, Trudeau ME, Merante P, Pintilie M, Weir LM, Olivotto IA. Tamoxifen with or without breast irradiation in women 50 years of age or older with early breast cancer. N Engl J Med. 2004 Sep 2;351(10):963-70.

ReferenceCitation: Hughes KS, Schnaper LA, Berry D, Cirrincione C, McCormick B, Shank B, Wheeler J, Champion LA, Smith TJ, Smith BL, Shapiro C, Muss HB, Winer E, Hudis C, Wood W, Sugarbaker D, Henderson IC, Norton L; Cancer and Leukemia Group B; Radiation Therapy Oncology Group; Eastern Cooperative Oncology Group. Lumpectomy plus tamoxifen with or without irradiation in women 70 years of age or older with early breast cancer. N Engl J Med. 2004 Sep 2;351(10):971-7.

ReferenceCitation: Polgár C, Fodor J, Major T, Németh G, Lövey K, Orosz Z, Sulyok Z, Takácsi-Nagy Z, Kásler M. Breast-conserving treatment with partial or whole breast irradiation for low-risk invasive breast carcinoma--5-year results of a randomized trial. Int J Radiat Oncol Biol Phys. 2007 Nov 1;69(3):694-702. Epub 2007 May 25.

ReferenceCitation: Kraus-Tiefenbacher U, Bauer L, Kehrer T, Hermann B, Melchert F, Wenz F. Intraoperative radiotherapy (IORT) as a boost in patients with early-stage breast cancer -- acute toxicity. Onkologie. 2006 Mar;29(3):77-82. Epub 2006 Mar 3.

ReferenceCitation: Kraus-Tiefenbacher U, Bauer L, Scheda A, Fleckenstein K, Keller A, Herskind C, Steil V, Melchert F, Wenz F. Long-term toxicity of an intraoperative radiotherapy boost using low energy X-rays during breast-conserving surgery. Int J Radiat Oncol Biol Phys. 2006 Oct 1;66(2):377-81. Epub 2006 Aug 2.

ReferenceCitation: Vaidya JS, Joseph DJ, Tobias JS, Bulsara M, Wenz F, Saunders C, Alvarado M, Flyger HL, Massarut S, Eiermann W, Keshtgar M, Dewar J, Kraus-Tiefenbacher U, Sütterlin M, Esserman L, Holtveg HM, Roncadin M, Pigorsch S, Metaxas M, Falzon M, Matthews A, Corica T, Williams NR, Baum M. Targeted intraoperative radiotherapy versus whole breast radiotherapy for breast cancer (TARGIT-A trial): an international, prospective, randomised, non-inferiority phase 3 trial. Lancet. 2010 Jul 10;376(9735):91-102. doi: 10.1016/S0140-6736(10)60837-9. Erratum in: Lancet. 2010 Jul 10;376(9735):90.

ReferenceCitation: Vaidya JS, Wenz F, Bulsara M, Tobias JS, Joseph DJ, Keshtgar M, Flyger HL, Massarut S, Alvarado M, Saunders C, Eiermann W, Metaxas M, Sperk E, Sütterlin M, Brown D, Esserman L, Roncadin M, Thompson A, Dewar JA, Holtveg HM, Pigorsch S, Falzon M, Harris E, Matthews A, Brew-Graves C, Potyka I, Corica T, Williams NR, Baum M; TARGIT trialists' group. Risk-adapted targeted intraoperative radiotherapy versus whole-breast radiotherapy for breast cancer: 5-year results for local control and overall survival from the TARGIT-A randomised trial. Lancet. 2014 Feb 15;383(9917):603-13. doi: 10.1016/S0140-6736(13)61950-9. Epub 2013 Nov 11. Erratum in: Lancet. 2014 Feb 15;383(9917):602.

ReferenceCitation: Vaidya JS, Bulsara M, Baum M, Wenz F, Massarut S, Pigorsch S, Alvarado M, Douek M, Saunders C, Flyger HL, Eiermann W, Brew-Graves C, Williams NR, Potyka I, Roberts N, Bernstein M, Brown D, Sperk E, Laws S, Sütterlin M, Corica T, Lundgren S, Holmes D, Vinante L, Bozza F, Pazos M, Le Blanc-Onfroy M, Gruber G, Polkowski W, Dedes KJ, Niewald M, Blohmer J, McCready D, Hoefer R, Kelemen P, Petralia G, Falzon M, Joseph DJ, Tobias JS. Long term survival and local control outcomes from single dose targeted intraoperative radiotherapy during lumpectomy (TARGIT-IORT) for early breast cancer: TARGIT-A randomised clinical trial. BMJ. 2020 Aug 19;370:m2836. doi: 10.1136/bmj.m2836.

lead_sponsor: Universitätsmedizin Mannheim

location_facility: Department of Radiotherapy University Hospital Mannheim

location_facility: Institut régional du Cancer de Montpellier

intervention_type: Radiation


title: Postoperative Patient-controlled Perineural Analgesia After Orthopedic Surgery: A Medico-economic Comparative Evaluation of Patient Management by Remote Control Versus Bedside Care

acronym: MICREL

summary: Perineural injection of local anesthesic is currently the reference method for the treatment of post operative pain in a patient undergoing major orthopedic surgery. Postoperative pain is a dynamic phenomena in every patient. It is classified as intense during the first postoperative hours after surgery, and decreases in a non-linear manner over the days following the procedure. PCA (patient control analgesia) infusion of local anesthesic allows an adaptation of the local analgesia doses to the evaluated pain scores, as well as permit a decrease in adverse events related to the continuous infusion technique (motor or sensory blockade, paresthesia, etc.). The physician can also modify the pump settings according to the postoperative rehabilitation plan.The use of new communication techniques such as "telemedecine" may be of interest in reducing treatment onset time and optimizing pain management. The remote control consists to change the settings of the pump after if the anesthesiologist was informed in real time (via a smartphone or a tablet) on patient pain level, sensory and motor blockades. The physician goes to a dedicated website (Micrel CareTM). and makes the necessary changes by remote control via a GPRS (General Packet Radio Service) connexion. The aim of this prospective, comparative, multicentric trial is to compare the effectiveness of patient management through two communication modalities: remote control versus bedside care.

study_start_date_type: Actual

status: Terminated

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Other

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Capdevila X, Macaire P, Bernard N, Biboulet P, Cuvillon P, Choquet O, Bringuier S. Remote transmission monitoring for postoperative perineural analgesia after major orthopedic surgery: A multicenter, randomized, parallel-group, controlled trial. J Clin Anesth. 2022 May;77:110618. doi: 10.1016/j.jclinane.2021.110618. Epub 2021 Dec 1.

lead_sponsor: University Hospital, Montpellier

location_country:
Netherlands
France
United Arab Emirates

location_facility: Department of Anesthesiology and critical care, Lapeyronie University Hospital

location_facility: Anesthesia Réanimation Department, Hôpital Saint Roch

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Unknown


title: A One Year Longitudinal Therapeutically Non-Interventional Study of MSRV-Env Burden in Multiple Sclerosis Patients (RRMS - SPMS - PPMS - CIS) as Assessed by PCR and ELISA in Blood

acronym: LOMBARD

summary: This study intends to explore evolution of MSRV expression by analyzing the levels of MSRV transcripts in blood, as well as the levels of the MSRV-Env protein in serum of MS patients. The study will be conducted over one year in four cohorts of patients with different forms of MS (remitting-relapsing MS i.e. RRMS, primary-progressive MS i.e. PPMS and secondary-progressive MS i.e. SPMS) and in clinically isolated syndrome (CIS) patients who have suffered a single clinical event but do not comply with diagnosis criteria for definite MS. The MSRV RNA and MSRV-Env protein levels will be correlated with the clinical evolution of patients and with the reverse transcriptase activity, inflammatory markers assessed by cytokines levels. A control group of healthy subjects will be included (the study, GN-E-003, is performed in parallel and is part of another dedicated protocol).

status: Completed

study_type: Observational

time_perspective: Prospective

lead_sponsor: GeNeuro Innovation SAS

location_country: France Switzerland Spain

location_facility: Hospital Universitari and Research Institute Vall d'Hebron - Servicio de Neuroimunologia de Nuestro Centro - Pg. Vall d'Hebron 119-129

location_facility: CHU Timone - Service de Neurologie et CRMBM CNRS 7339 - 264, rue Saint Pierre

location_facility: Centre Hospitalier Universitaire Vaudois - Dpt of Clinical Neurosciences - Neurology /Batiment 10-131 - Rue du Bugnon 46 -

location_facility: Hospices civils de Lyon - Service de Neurologie A - 59 Boulevard Pinel

lead_sponsor_type: industriel

status_simplified: Completed


title: A Randomized, Double-blind, Placebo-controlled, First-in-human, 3-Part Study of Orally Administered ALS-002200 to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Dosing and Food-effect in Healthy Volunteers, and Multiple Ascending Dosing in Subjects With Chronic Hepatitis C Genotype 1 Infection

summary:
This randomized, double-blind, placebo-controlled, 3-part study will assess the safety, tolerability, and pharmacokinetics of orally administered ALS-002200 in healthy volunteers (HV) and subjects with chronic hepatitis C (CHC) genotype 1 infection.

Part 1 will assess single ascending dosing pharmacokinetics and safety in HV. Part 2 will assess food effects on pharmacokinetics in HV. Part 3 will assess multiple ascending dosing pharmacokinetics and safety in subjects with CHC genotype 1 infection.

primary_purpose: Treatment

lead_sponsor: Alios Biopharma Inc.

location_country:
France
Moldova, Republic of
Romania

location_facility: Biotrial Arensia

intervention_type: Drug


type: Other Identifier

type: EudraCT Number

title: An Open-label, Multicenter, Phase 1/2 Study of JNJ-40346527, an FMS Inhibitor, in Subjects With Relapsed or Refractory Hodgkin Lymphoma

summary: The purpose of this study is to determine the safety, pharmacokinetics, and preliminary efficacy information of JNJ-40346527 in patients with relapsed or refractory Hodgkin lymphoma.

lead_sponsor: Janssen Research & Development, LLC

location_country: Germany France


title: Analgesic Profile of 3 New Ibuprofen Lozenges (V0498TA01A 15 mg, 25 mg, 35 mg) After Single Administration in Acute Sore Throat Pain

lead_sponsor: Pierre Fabre Medicament

source: euctr

location_country:
Germany
France
United Kingdom

location_facility:
Eurofins Optimed Lyon
Eurofins Optimed

summary:
"Sore throat is one of the most common complaints encountered in clinical practice. And in 65% of cases, the infection is thought to be viral in nature.

The aim of this study is to evaluate the analgesic profile of 3 Ibuprofen lozenges after single administration in acute sore throat pain."


title: An Open-Label, Dose-escalation, Phase I/IIa Study to Determine the Maximum Tolerated Dose, Recommended Dose, Efficacy, Pharmacokinetics and Pharmacodynamics of the Dual VEGFR-FGFR Tyrosine Kinase Inhibitor, E-3810, Given Orally as Single Agent to Patients With Advanced Solid Tumours

summary:
Co-selective inhibition of VEGFRs and FGFR has the potential benefit of blocking the two most relevant players in tumor angiogenesis and simultaneously targeting proliferation in FGF-driven tumors. Lucitanib is a novel dual-targeted small molecule inhibitor of VEGFR1, 2, 3 and FGFR1 showing strong anti-angiogenic and anti-tumor activity in preclinical models at well-tolerated oral doses, with a favorable pharmacokinetic profile. These properties make it an attractive candidate for development in humans.

This is an open-label, uncontrolled, non-randomized, PhaseI/IIa study and its primary objective is to determine the Maximum Tolerated Dose (MTD) of Lucitanib administered orally, once daily, on a continuous schedule over the initial 28-day cycle.

Secondary objectives are to determine the safety profile, pharmacokinetics, pharmacodynamics and antitumour activity of Lucitanib, given as a single agent to adult patients with advanced solid tumours.

The study consists of two phases, a dose escalation phase followed by a dose-expansion phase at the identified Recommended Dose (RD). Eligible patients have histologically or cytologically confirmed locally advanced or metastatic solid tumours, relapsed or refractory to standard therapy. For the dose expansion, patients should have tumours bearing FGFR1 or 11q 12-14 amplification, assessed by FISH or CGH array, or "sensitive" to antiangiogenic treatment. These latter are defined as patients who have relapsed after having experienced stable disease (lasting at least six months) or partial response with prior treatment with an approved antiangiogenic regimen or patients with tumour types known to be potentially responsive to antiangiogenic agents but without such pretreatment if no antiangiogenic agents were approved and/or available for that specific condition (e.g thyroid cancer, thymic carcinoma).

Serial safety assessments, including evaluation of symptoms, physical examination and blood and urine laboratory analyses are performed throughout the study. Cardiac functions and blood pressure are monitored in consultation with a cardiologist. PK parameters are determined on plasma samples collected during the first 4-week cycle and analyzed using a validated LC-MS/MS method. Correlative studies include: (i) quantitative assessment of the effects of E-3810 on tumor vasculature by DCE-MRI and DCE-US imaging; (ii) assay of angiogenesis biomarkers i.e. soluble VEGFR2, VEGFR1, VEGF, bFGF, Collagen IV, FGF23 and PIGF(by ELISA) and circulating endothelial and progenitors cells (CEC and CEP). Tumor response is based on imaging according to RECIST; circulating tumor cells (CTC) are measured by the immunomagnetic CellSearch method.

In patients with tumours bearing FGFR1 amplifications the efficacy of Lucitanib will be formally tested according to a phase IIa design (one-stage Flaming design, H0=0.05, H1=0,30, power 0,80.

ReferenceCitation: Liao M, Zhou J, Wride K, Lepley D, Cameron T, Sale M, Xiao J. Population Pharmacokinetic Modeling of Lucitanib in Patients with Advanced Cancer. Eur J Drug Metab Pharmacokinet. 2022 Sep;47(5):711-723. doi: 10.1007/s13318-022-00773-w. Epub 2022 Jul 18.

ipd_sharing: Yes

ipd_sharing_description:
Researchers can ask for a study protocol, patient-level and/or study-level clinical trial data including clinical study reports (CSRs).

They can ask all interventional clinical studies:

submitted for new medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
Where Servier or an affiliate are the Marketing Authorization Holders (MAH). The date of the first Marketing Authorization of the new medicine (or the new indication) in one of the EEA Member States will be considered within this scope.

lead_sponsor: Institut de Recherches Internationales Servier

location_country: France Spain Italy

location_facility:
Institute Gustave Roussy
Hopital Louis Pradel
Vall d' Hebron University Hospital
European Institute of Oncology


title: Open Label Treatment of Patients With Chronic Hand Dermatitis Who Have Participated in a Previous Clinical Trial Involving Oral Alitretinoin

summary: The purpose of the study is to investigate the safety and efficacy of alitretinoin in chronic hand eczema that is refractory to topical corticosteroids.

enrollment_type: Anticipated

lead_sponsor: Basilea Pharmaceutica


summary: Part 1: The primary purpose is to determine the recommended dose of E7070 in combination with capecitabine by dose adjustment. Part 2: The primary purpose is to determine the safety and efficacy of the combination in patients with metastatic CRC resistant to 5-fluorouracil and irinotecan.

design_allocation: Non-Randomized

lead_sponsor: Eisai Limited

location_country: Germany France Netherlands

location_facility:
Centre Léon Bérard
Institut Curie
Universitätsklinikum der GHS-Essen
Netherlands Cancer Institute


title: A Randomized, Eight-week Double-blind, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of the Combination of Aliskiren / Amlodipine (300/5 mg and 300/10 mg) in Comparison With Aliskiren 300 mg in Patients With Essential Hypertension Not Adequately Responsive to Aliskiren 300 mg Monotherapy

summary: This study will assess the safety and efficacy of combination aliskiren/amlodipine in patients not adequately controlled with aliskiren alone

ReferenceCitation: Glorioso N, Thomas M, Troffa C, Argiolas G, Patel S, Baek I, Zhang J. Antihypertensive efficacy and tolerability of aliskiren/amlodipine single- pill combinations in patients with an inadequate response to aliskiren monotherapy. Curr Vasc Pharmacol. 2012 Nov;10(6):748-55.

lead_sponsor: Novartis

location_country:
Spain
Italy
Estonia
Lithuania
Venezuela
Korea, Republic of
India
France
Iceland

location_facility:
Investigative Site
Investigative site


title: A Phase 1 Study of TAS2940 in Patients With Locally Advanced or Metastatic Solid Tumors With EGFR and / or HER2 Aberrations

summary: This is a first-in-human, open label, multicenter study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and the preliminary antitumor activity of TAS2940 in patients with advanced or metastatic solid tumors who are not candidates for approved or available therapies.

status: Recruiting

study_completion_date_type: Anticipated

ipd_sharing: No

lead_sponsor: Taiho Oncology, Inc.

location_country:
United States
France

location_facility: University of Texas MD Anderson Cancer Center

status_simplified: Ongoing


title: Multicenter Phase 3 Pivotal Study to Evaluate the Safety and Efficacy of TOOKAD (Padeliporfin) Vascular Targeted Photodynamic Therapy in the Treatment of Low Grade Upper Tract Urothelial Cancer

summary: This is a phase 3, open label, single arm study of padeliporfin in the treatment of Upper Tract Urothelial Carcinoma (UTUC). The ENLIGHTED study will recruit patients with low-grade non-invasive upper tract urothelial carcinoma in either the kidney or the ureter. Patients will be treated with padeliporfin VTP in two phases: an Induction Treatment Phase and a Maintenance Treatment Phase and will be followed up for up to an additional 48 months in the long term (non intervention) follow up phase with the specific duration depending on the patient's response to treatment

lead_sponsor: Steba Biotech S.A.

location_facility:
Hôpital Pitié Salpêtrière
Carolina Urologic Research Center
Memorial Sloan Kettering Cancer Center


title: Comparing Impact of Operation and Fertility Treatment on Fertility for Women With Deep Infiltrating Endometriosis: A Multicenter Randomized Controlled Trial

acronym: EFFORT

summary: The EFFORT study compares the impact on fertility of operation or fertility treatment (IVF, in vitro fertilization) in a multicenter randomized controlled trial. The study population consists of women with colorectal deep infiltrating endometriosis and a pregnancy intention. These women will be randomized to either of the two treatment groups: Group A = Operation or Group B = fertility treatment (IVF). Group A will be further divided postoperatively into spontaneous conception or IVF depending on the Endometriosis Fertility Index score.

ReferenceCitation: Raos M, Roman H, Seyer-Hansen M, Kesmodel US, Knudsen UB. EFFORT study: Comparing impact of operation and assisted reproductive technologies on fertility for women with deep infiltrating endometriosis - study protocol for a multicentre randomised trial. BMJ Open. 2022 Apr 11;12(4):e052877. doi: 10.1136/bmjopen-2021-052877.

lead_sponsor: Horsens Hospital

location_country: Denmark France

location_facility: The Endometriosis Center, Clinique Tivoli-Ducos

intervention_type: Procedure


title: Artificial Intelligence for Real-time Detection and Monitoring of Colorectal Polyps

summary: The investigators hypothesize that the clinical implementation of a deep learning AI system is an optimal tool to monitor, audit and improve the detection and classification of polyps and other anatomical landmarks during colonoscopy. The objectives of this study are to generate preliminary data to evaluate the effectiveness of AI-assisted colonoscopy on: a) the rate of detection of adenomas; b) the automatic detection of the anatomical landmarks (i.e., ileocecal valve and appendiceal orifice).

primary_purpose: Diagnostic

lead_sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

location_country: Canada France

location_facility: Centre Hospitalier Universitaire de Montréal

intervention_type: Diagnostic Test


title: A Phase 1 Study of TAS0612 in Patients With Locally Advanced or Metastatic Solid Tumors

summary: The purpose of this study is to see if TAS0612 is safe in participants with advanced or metastatic solid tumor cancer.

location_facility: Centre de Lutte Contre le Cancer Gustave Roussy


title: Multicenter International Observational Study to Identify Trajectories of Cardiac Allograft Vasculopathy After Heart Transplantation and Their Specific Determinants

acronym: TRAJ-CAV

summary: This project aims: i) to identify Cardiac Allograft Vasculopathy (CAV) trajectories after heat transplantation using latent class mixed modeling, ii) to characterize the global and specific determinants of different trajectories and iii) to provide an easily accessible tool to project individual probability of CAV trajectory belonging.

ReferenceCitation: Loupy A, Coutance G, Bonnet G, Van Keer J, Raynaud M, Aubert O, Bories MC, Racapé M, Yoo D, Duong Van Huyen JP, Bruneval P, Taupin JL, Lefaucheur C, Varnous S, Leprince P, Guillemain R, Empana JP, Levine R, Naesens M, Patel JK, Jouven X, Kobashigawa J. Identification and Characterization of Trajectories of Cardiac Allograft Vasculopathy After Heart Transplantation: A Population-Based Study. Circulation. 2020 Jun 16;141(24):1954-1967. doi: 10.1161/CIRCULATIONAHA.119.044924. Epub 2020 May 4.

lead_sponsor: Paris Translational Research Center for Organ Transplantation

location_country:
United States
France
Belgium

location_facility:
Maarten Naesens
Jon Kobashigawa
Paris Transplant Group


title: In Vivo Determination of Knee Kinematics for Subjects Having a Zimmer-Biomet Persona PCR or PS TKA

acronym: PCR PS TKA

summary: 25 subjects implanted with a Zimmer-Biomet Posterior Cruciate Retaining (PCR) total knee arthroplasty (TKA) and 25 subjects implanted with a Zimmer-Biomet Posterior Stabilizing (PS) TKA will be asked to perform stepping up and deep knee bend activities while under fluoroscopic surveillance (x-ray video). The movements between the two different types of TKAs will be compared.

time_perspective: Retrospective

ipd_sharing_description: Researchers would like to retain this study data in our secure database so as to continue to add relevant, current data to our digital collection to help us work with manufacturers in the future to create better implants that last longer and will not require revision surgery. Participants will be asked if their study data may remain a part of the University of Tennessee's Center for Musculoskeletal Research data collection for use in future studies in the IC. Identifiers are automatically removed from the database upon entry into the secure server. Data shared with sponsors is de-identified.

lead_sponsor: The University of Tennessee, Knoxville

location_facility: The Institute for Locomotion, Aix-Marseille University, Hopital Sainte-Marguerite

intervention_type: Device


title: A Phase 1, Multicenter, Open-label, Dose-Escalation, Safety, Pharmacokinetic and Pharmacodynamic Study of TRK-950 Given Intravenously in Patients With Advanced Solid Tumors

summary:
To determine the maximum tolerated dose (MTD) and the dose limiting toxicities (DLTs) of TRK-950 as single agent
To establish the dose of TRK-950 recommended for future phase 2 studies

lead_sponsor: Toray Industries, Inc

location_facility:
Mayo Clinic
HonorHealth Research Institute
Centre Léon Bérard

intervention_type: Biological


title: An Open-Label Multicenter Phase 1 Study of E7046 in Subjects With Selected Advanced Malignancies

summary: This is an open label, multicenter, Phase 1 study of E7046 to assess the safety and tolerability of E7046 and to determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of E7046.

ReferenceCitation: Hong DS, Parikh A, Shapiro GI, Varga A, Naing A, Meric-Bernstam F, Ataman Ö, Reyderman L, Binder TA, Ren M, Liu M, Dayal S, Siu AY, Sachdev P, Xu L, Bhagawati-Prasad V, Tchakov I, Ooi CE, Bao X, Marabelle A. First-in-human phase I study of immunomodulatory E7046, an antagonist of PGE(2)-receptor E-type 4 (EP4), in patients with advanced cancers. J Immunother Cancer. 2020 Jun;8(1). pii: e000222. doi: 10.1136/jitc-2019-000222.

lead_sponsor: Eisai Inc.


title: A Simple Approach to Estimate Alveolar Recruitability in Patients With Acute Respiratory Distress Syndrome: a Validation Study

summary: This study will test the validity of a new approach to assess alveolar recruitability at the bedside in comparison to direct measurements of lung volume and derecruitment.

ReferenceType: background

ReferenceCitation: Chen L, Brochard L. Lung volume assessment in acute respiratory distress syndrome. Curr Opin Crit Care. 2015 Jun;21(3):259-64. doi: 10.1097/MCC.0000000000000193. Review.

ReferenceCitation: Ashbaugh DG, Bigelow DB, Petty TL, Levine BE. Acute respiratory distress in adults. Lancet. 1967 Aug 12;2(7511):319-23.

ReferenceCitation: Gattinoni L, Caironi P, Cressoni M, Chiumello D, Ranieri VM, Quintel M, Russo S, Patroniti N, Cornejo R, Bugedo G. Lung recruitment in patients with the acute respiratory distress syndrome. N Engl J Med. 2006 Apr 27;354(17):1775-86.

ReferenceCitation: Maggiore SM, Jonson B, Richard JC, Jaber S, Lemaire F, Brochard L. Alveolar derecruitment at decremental positive end-expiratory pressure levels in acute lung injury: comparison with the lower inflection point, oxygenation, and compliance. Am J Respir Crit Care Med. 2001 Sep 1;164(5):795-801.

ReferenceCitation: Dellamonica J, Lerolle N, Sargentini C, Beduneau G, Di Marco F, Mercat A, Richard JC, Diehl JL, Mancebo J, Rouby JJ, Lu Q, Bernardin G, Brochard L. PEEP-induced changes in lung volume in acute respiratory distress syndrome. Two methods to estimate alveolar recruitment. Intensive Care Med. 2011 Oct;37(10):1595-604. doi: 10.1007/s00134-011-2333-y. Epub 2011 Aug 25.

ReferenceCitation: Chen L, Del Sorbo L, Grieco DL, Junhasavasdikul D, Rittayamai N, Soliman I, Sklar MC, Rauseo M, Ferguson ND, Fan E, Richard JM, Brochard L. Potential for Lung Recruitment Estimated by the Recruitment-to-Inflation Ratio in Acute Respiratory Distress Syndrome. A Clinical Trial. Am J Respir Crit Care Med. 2020 Jan 15;201(2):178-187. doi: 10.1164/rccm.201902-0334OC.

lead_sponsor: Unity Health Toronto

location_country: Canada China France

location_facility: Beijing Tiantan Hospital, Capital Medical University

location_facility: Centre Hospitalier Universitaire - CHU Angers


title: Assessment of Diagnostic Accuracy and Performance of Digital Breast Tomosynthesis Compared to Mammography (ADAPT Trial) ADAPT-BX: Recruitment Plan for Initially Asymptomatic Women Referred for Breast Biopsy

acronym: ADAPT

summary: The aim of this recruitment plan (ADAPT-BX) is to collect image and technical data on both digital breast tomosynthesis (DBT) and full-field digital mammography (FFDM), along with other subject data including histology results from biopsy specimen examination and cancer classification data from initially asymptomatic women referred for biopsy after recall from screening and diagnostic work-up. These data will be included in a subsequent and prospectively planned pooled analysis described in a separate protocol (ADAPT-BIE) examining superiority of DBT to FFDM for breast cancer diagnosis and other clinical performance measures.

lead_sponsor: GE Healthcare

location_facility: Boca Raton Regional Hospital Christine E. Lynn Women's Health and Wellness Institute

location_facility: Cooper Health - Cooper Breast Imaging Centers


type: Other Grant/Funding Number

title: Impact of Nasal Mask/Oronasal Mask on Compliance to Treatment With Continuous Positive Airway Pressure (CPAP) in Patients With Obstructive Sleep Apnea

summary: CPAP is the most effective treatment of obstructive sleep apnea. Oro-nasal masks may be used in case of mouth leaks but these are associated with higher positive pressure needs and lower compliance to treatment. The present investigation evaluates if CPAP compliance would increase when an oral appliance is used in combination with a nasal mask compared to the use of an oro-nasal mask. Eligible patients are those demonstrating a low compliance when using an oro-nasal mask during CPAP therapy. Patients will be treated with automatic CPAP with one of the above-detailed interfaces for 4 weeks and data will be extracted from the machine report in each condition.

ReferenceCitation: Borel JC, Tamisier R, Dias-Domingos S, Sapene M, Martin F, Stach B, Grillet Y, Muir JF, Levy P, Series F, Pepin JL; Scientific Council of The Sleep Registry of the French Federation of Pneumology (OSFP). Type of mask may impact on continuous positive airway pressure adherence in apneic patients. PLoS One. 2013 May 15;8(5):e64382. doi: 10.1371/journal.pone.0064382. Print 2013.

ReferenceCitation: Léotard A, Lesgoirres M, Daabek N, Lebret M, Bailly S, Verain A, Series F, Pépin JL, Borel JC. Adherence to CPAP with a nasal mask combined with mandibular advancement device versus an oronasal mask: a randomized crossover trial. Sleep Breath. 2019 Sep;23(3):885-888. doi: 10.1007/s11325-018-01772-5. Epub 2019 Jan 28.

lead_sponsor: Laval University

location_facility: CHUM IUCPQ AGIRADOM


title: Determination of Glycaemic Index and Insulinaemic Index Values of 6 Cereal Products in 3 Separate Research Centers

summary: The purpose of this study is to determine and compare the glycaemic index values and response parameters of 6 food products between 3 laboratories.

primary_purpose: Basic Science

lead_sponsor: Mondelēz International, Inc.

location_country: Australia Canada France

location_facility: Human Nutrition Unit, The University of Sydney


title: Cone Beam CT (CS 9300) for Diagnosis of Select Otorhinolaryngology (ENT) Indications at Lower Dose

acronym: CBCT-ENT

summary: The study objective is to compare the CBCT images generated by the CS 9300 to those generated by conventional CT.

lead_sponsor: Carestream Health, Inc.

location_facility:
Johns Hopkins Medical Center
C.H.U Bicetre
Sint-Augustinus Hospital


title: A Pilot Study to Investigate Filiation Between Primary and Secondary Lesions in Acne Patients

summary: Exploratory, international, multi-centre, randomized, investigator blinded study in acne

lead_sponsor: Galderma R&D


title: An Open-Label, Phase I, Dose Escalation Study Evaluating the Safety, Tolerability, and Pharmacokinetics of GDC-0425 Administered With and Without Gemcitabine in Patients With Refractory Solid Tumors or Lymphoma

summary: This is an open-label, multicenter, Phase I, dose-escalation study to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of GDC-0425 administered with and without gemcitabine.

lead_sponsor: Genentech, Inc.

location_facility: Institut Gustave Roussy; Ser. de Med. Nucleaire; Cancerologie Endo


title: Post-Implant Performance of the EC-3 IOL ADDENDUM TO THE PROTOCOL: Clinical Evaluation of the EC-3 Hydrophobic Acrylic Posterior Chamber Aphakic Intraocular Lens

summary: The purpose of this study is to obtain data on the performance of the EC-3 lens at an interval of two years (and beyond) from subjects who were implanted. The primary aim of the study will be to evaluate the presence, if any, of PCO, lens glistening, and other anomalies in the subjects.

status: Unknown status

time_perspective: Cross-Sectional

lead_sponsor: Aaren Scientific Inc.

location_facility:
Cabinet d'Ophtalmologie du Dr. Pey
Stephenson Eye Associates
Eyesight Ophthalmic Services


title: An Open-Label, Dose-Escalation, Phase IB II Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of the MEK Inhibitor GSK1120212 in Combination With Oral Everolimus in Subjects With Solid Tumors

acronym: Cancer

summary: The purpose of this study is to determine the recommended dose and regimen for the orally administered MEK inhibitor GSK1120212 dosed in combination with everolimus in subjects with solid tumors. The escalation part of the study will determine the MTD. The combination will be further explored in the expansion part in subjects with metastatic pancreatic cancer. In addition, subjects with KRAS mutant non-small cell lung cancer will be enrolled.

ReferenceCitation: Tolcher AW, Bendell JC, Papadopoulos KP, Burris HA 3rd, Patnaik A, Jones SF, Rasco D, Cox DS, Durante M, Bellew KM, Park J, Le NT, Infante JR. A phase IB trial of the oral MEK inhibitor trametinib (GSK1120212) in combination with everolimus in patients with advanced solid tumors. Ann Oncol. 2015 Jan;26(1):58-64. doi: 10.1093/annonc/mdu482. Epub 2014 Oct 24.

lead_sponsor: GlaxoSmithKline


title: A PhaseI/II, Open Label Multi-Centre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the JAK2 Inhibitor AZD1480 Administered Orally to Patients With Primary Myelofibrosis (PMF) and Post-Polycythaemia Vera/Essential Thrombocythaemia Myelofibrosis (Post-PV/ET MF

summary: This study is being conducted to test study drug AZD1480 to see how it may work to treat myeloproliferative diseases. The main purpose of this study is to determine the safety and tolerability of AZD1480. This is the first time the drug has been given to humans and is classed as a first time in man study. Its main purpose is to establish a safe dosage of the drug and provide additional information on any potential side effects this drug may cause. The study will also assess the blood levels and action of AZD1480 in the body over a period of time and will indicate whether the drug has a therapeutic effect on myeloproliferative diseases.

lead_sponsor: AstraZeneca


title: A Prospective Descriptive, Multi-National, Multi-Centre Observational Study of Burden of Upper GI-Symptoms in Subjects With Cardiovascular Risk or Disease Receiving Treatment With Low-Dose Aspirin

summary: The purpose of this study is to investigate the burden of upper gastrointestinal symptoms in patients with cardiovascular disease taking low dose aspirin

ReferenceCitation: Bytzer P, Pratt S, Elkin E, Næsdal J, Sörstadius E. Burden of upper gastrointestinal symptoms in patients receiving low-dose acetylsalicylic acid for cardiovascular risk management: a prospective observational study. Am J Cardiovasc Drugs. 2013 Feb;13(1):27-35. doi: 10.1007/s40256-012-0001-4.

ReferenceCitation: Pratt S, Thompson VJ, Elkin EP, Næsdal J, Sörstadius E. The impact of upper gastrointestinal symptoms on nonadherence to, and discontinuation of, low-dose acetylsalicylic acid in patients with cardiovascular risk. Am J Cardiovasc Drugs. 2010;10(5):281-8. doi: 10.2165/11584410-000000000-00000.

location_country:
United States
Canada
France


title: A Phase 2 Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic Fibrosis

summary: In some participants with cystic fibrosis (CF), the disease is caused by a nonsense mutation (premature stop codon) in the gene that makes the cystic fibrosis transmembrane regulator (CFTR) protein. Ataluren has been shown to partially restore CFTR production in animals with CF due to a nonsense mutation. The main purpose of this study is to understand whether ataluren can safely increase functional CFTR protein in the cells of participants with CF due to a nonsense mutation.

ReferenceCitation: Sermet-Gaudelus I, Boeck KD, Casimir GJ, Vermeulen F, Leal T, Mogenet A, Roussel D, Fritsch J, Hanssens L, Hirawat S, Miller NL, Constantine S, Reha A, Ajayi T, Elfring GL, Miller LL. Ataluren (PTC124) induces cystic fibrosis transmembrane conductance regulator protein expression and activity in children with nonsense mutation cystic fibrosis. Am J Respir Crit Care Med. 2010 Nov 15;182(10):1262-72. doi: 10.1164/rccm.201001-0137OC. Epub 2010 Jul 9.

lead_sponsor: PTC Therapeutics

location_country: France Belgium

location_facility:
Reine Fabiola Hospital
Hopital Necker Enfants Malades
UZ Gasthuisberg Leuven


title: A Multicenter, Open-label, Single-arm, Two-stage Study of the Efficacy and Safety of AVE0005 (VEGF Trap) Administered Intravenously Every 2 Weeks in Patients With Platinum- and Erlotinib-resistant Locally Advanced or Metastatic Non-small-cell Lung Adenocarcinoma

summary:
This study evaluated the efficacy and safety of aflibercept in the treatment of participants with advanced chemoresistant non-small cell lung adenocarcinoma (NSCLA).

Primary objective:

To determine the overall objective response rate (ORR) of AVE0005 (ziv-aflibercept, aflibercept, VEGF trap, ZALTRAP®) 4.0 mg/kg intravenously (IV) every 2 weeks in participants with platinum- and erlotinib-resistant, locally advanced or metastatic NSCLA.

Secondary objective:

To assess duration of response (DR), progression-free survival (PFS), and overall survival (OS) in this participant population
To evaluate the safety profile of IV AVE0005 (ziv-aflibercept, aflibercept, VEGF trap, ZALTRAP®).

This study employed an Independent Review Committee (IRC) for radiological tumor assessments. For all tumor assessment-related efficacy variables, two analyses were performed: the primary analysis was based on Independent Review Committee (IRC) reviewed data and the secondary analysis was based on Investigator evaluation.

In addition, both Response Evaluation Criteria In Solid Tumors (RECIST) and Modified Response Evaluation Criteria In Solid Tumors (mRECIST) were used to assess tumors. Where as RECIST criteria only consider the longest diameter of the tumors for calculations pertaining to changes in tumor size, mRECIST assessments also account for the differences in the cavities of lesions observed in non-small-cell lung cancer (NSCLC). Responses based on RECIST and mRECIST are reported.

ReferenceType: result

ReferenceCitation: Leighl NB, Raez LE, Besse B, Rosen PJ, Barlesi F, Massarelli E, Gabrail N, Hart LL, Albain KS, Berkowitz L, Melnyk O, Shepherd FA, Sternas L, Ackerman J, Shun Z, Miller VA, Herbst RS. A multicenter, phase 2 study of vascular endothelial growth factor trap (Aflibercept) in platinum- and erlotinib-resistant adenocarcinoma of the lung. J Thorac Oncol. 2010 Jul;5(7):1054-9.

lead_sponsor: Sanofi


title: Utility of Recombinant Human Thyrotropin (rTSH) PET-CT Fusion Scanning to Identify Residual Well-differentiated Epithelial Thyroid Cancer

summary: The purpose of this study is to determine [for patients with previously treated well-differentiated thyroid cancer and evidence of residual disease based on serum thyroglobulin (Tg) level] whether positron emission tomography-computed tomography (PET-CT) fusion scanning performed after recombinant thyroid-stimulating hormone (TSH) (rTSH, thyrotropin alfa for injection) will be more sensitive for the detection of disease sites than PET-CT scanning without rTSH. The study will also determine if this information will significantly alter the therapeutic approach in some patients.

ReferenceCitation: Chin BB, Patel P, Cohade C, Ewertz M, Wahl R, Ladenson P. Recombinant human thyrotropin stimulation of fluoro-D-glucose positron emission tomography uptake in well-differentiated thyroid carcinoma. J Clin Endocrinol Metab. 2004 Jan;89(1):91-5.

ReferenceCitation: Pacini F, Ladenson PW, Schlumberger M, Driedger A, Luster M, Kloos RT, Sherman S, Haugen B, Corone C, Molinaro E, Elisei R, Ceccarelli C, Pinchera A, Wahl RL, Leboulleux S, Ricard M, Yoo J, Busaidy NL, Delpassand E, Hanscheid H, Felbinger R, Lassmann M, Reiners C. Radioiodine ablation of thyroid remnants after preparation with recombinant human thyrotropin in differentiated thyroid carcinoma: results of an international, randomized, controlled study. J Clin Endocrinol Metab. 2006 Mar;91(3):926-32. Epub 2005 Dec 29.

ReferenceCitation: Leboulleux S, Schroeder PR, Busaidy NL, Auperin A, Corone C, Jacene HA, Ewertz ME, Bournaud C, Wahl RL, Sherman SI, Ladenson PW, Schlumberger M. Assessment of the incremental value of recombinant thyrotropin stimulation before 2-[18F]-Fluoro-2-deoxy-D-glucose positron emission tomography/computed tomography imaging to localize residual differentiated thyroid cancer. J Clin Endocrinol Metab. 2009 Apr;94(4):1310-6. doi: 10.1210/jc.2008-1747. Epub 2009 Jan 21.

lead_sponsor: Johns Hopkins University

location_facility: Johns Hopkins Division of Endocrinology & Metabolism


title: A Phase I Study Of Seven Day Continuous Intrathecal/Intraventricular Infusion Of Topotecan For Patients With Recurrent, Progressive Or Refractory Leptomingeal Disease

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of intrathecal or intraventricular topotecan in treating recurrent, progressive, or refractory cancer that is metastatic to the lining around the brain.

lead_sponsor: NYU Langone Health

location_facility: Herbert Irving Comprehensive Cancer Center

location_facility: NYU School of Medicine's Kaplan Comprehensive Cancer Center


title: A Phase 1, Open-Label, Single-Dose, Non-Randomized Study to Evaluate Pharmacokinetics and Pharmacodynamics of Edoxaban in Pediatric Patients

lead_sponsor: Daiichi Sankyo, Inc.

ipd_sharing_description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

location_country:
Spain
Italy
United Kingdom
Lebanon
Canada
India
United States
France
Turkey

location_facility: University of California, Los Angeles (UCLA)

location_facility: Lucile Packard Children's Hospital Stanford University

location_facility: Hammoud Hospital University Medical Center

location_facility: Indiana Hemophilia and Thrombosis Center

location_facility: St. Jude Children's Research Hospital, Inc.

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

location_facility: Ege University Medical Faculty - Department of Pediatric Hematology

location_facility: University of Louisville ; Kosair Charities Pediatric Clincial Research Unit

location_facility: University Hospitals Case Medical Center - Rainbow Babies and Children's Hospital

location_facility: A O Universita degli Studi di Padova ; Dipartimento di Salute della Donna e del Bambino-Universita di Padova

location_facility: Istituto Giannina Gaslini - UOSD Emostasi e Trombosi

summary: This is the first evaluation of edoxaban in pediatric subjects. In this Phase 1 study, a single dose of edoxaban will be given to pediatric subjects who require anticoagulant therapy to see what the body does to the drug (pharmacokinetics) and what the drug does to the body (pharmacodynamics), and to compare if these effects are similar to those observed in adults.


title: Pregnancy Outcomes According to the Gestational Age of Acquiring COVID-19 : an International Case-control Study

summary:
A new coronavirus, called severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) appeared in Wuhan, China and it arrived to Europe 2-3 months later. It infected millions of persons and led to the death of thousands until May 2020 where numbers of infections per week decreased significantly. However, starting September, number of infections started to escalate again and continued to rise until now.

Hundreds of good quality articles were published during this period to study the relationship and effects of this virus on pregnancy and vice versa, as well as to determine the adverse neonatal and obstetrical outcomes following the infection. In a case-control study using propensity score matching at the level of age, body mass index and comorbidities (diabetes, hypertension, asthma), pregnant women over 20 week's gestation had significantly higher risk for intensive care unit stay, endotracheal intubation, hospitalization for disease related symptoms and need for oxygen therapy. A new systematic review also demonstrated increased risk for ICU admission in pregnant women compared to non-pregnant women and to non-infected pregnant women.

On the other hand, many researchers have demonstrated that the rates of preterm delivery and cesarean delivery have increased as well, others reported a close relation between SARS-CoV2 infection and preeclampsia or preeclampsia like condition. Enormous effort was done in order to understand adverse outcomes related to this infection, however, most studies included patients in the third or late second trimester. Few studies stratified adverse outcomes of the patients according to the trimester of infection.

ReferenceCitation: Badr DA, Mattern J, Carlin A, Cordier AG, Maillart E, El Hachem L, El Kenz H, Andronikof M, De Bels D, Damoisel C, Preseau T, Vignes D, Cannie MM, Vauloup-Fellous C, Fils JF, Benachi A, Jani JC, Vivanti AJ. Are clinical outcomes worse for pregnant women at ≥20 weeks' gestation infected with coronavirus disease 2019? A multicenter case-control study with propensity score matching. Am J Obstet Gynecol. 2020 Nov;223(5):764-768. doi: 10.1016/j.ajog.2020.07.045. Epub 2020 Jul 27.

ReferenceCitation: Allotey J, Stallings E, Bonet M, Yap M, Chatterjee S, Kew T, Debenham L, Llavall AC, Dixit A, Zhou D, Balaji R, Lee SI, Qiu X, Yuan M, Coomar D, Sheikh J, Lawson H, Ansari K, van Wely M, van Leeuwen E, Kostova E, Kunst H, Khalil A, Tiberi S, Brizuela V, Broutet N, Kara E, Kim CR, Thorson A, Oladapo OT, Mofenson L, Zamora J, Thangaratinam S; for PregCOV-19 Living Systematic Review Consortium. Clinical manifestations, risk factors, and maternal and perinatal outcomes of coronavirus disease 2019 in pregnancy: living systematic review and meta-analysis. BMJ. 2020 Sep 1;370:m3320. doi: 10.1136/bmj.m3320. Update in: BMJ. 2022 May 30;377:o1205.

ReferenceCitation: Khalil A, von Dadelszen P, Draycott T, Ugwumadu A, O'Brien P, Magee L. Change in the Incidence of Stillbirth and Preterm Delivery During the COVID-19 Pandemic. JAMA. 2020 Jul 10. doi: 10.1001/jama.2020.12746. [Epub ahead of print]

ReferenceCitation: Prabhu M, Cagino K, Matthews KC, Friedlander RL, Glynn SM, Kubiak JM, Yang YJ, Zhao Z, Baergen RN, DiPace JI, Razavi AS, Skupski DW, Snyder JR, Singh HK, Kalish RB, Oxford CM, Riley LE. Pregnancy and postpartum outcomes in a universally tested population for SARS-CoV-2 in New York City: a prospective cohort study. BJOG. 2020 Nov;127(12):1548-1556. doi: 10.1111/1471-0528.16403. Epub 2020 Aug 13.

ReferenceCitation: Berghella V, Boelig R, Roman A, Burd J, Anderson K. Decreased incidence of preterm birth during coronavirus disease 2019 pandemic. Am J Obstet Gynecol MFM. 2020 Nov;2(4):100258. doi: 10.1016/j.ajogmf.2020.100258. Epub 2020 Oct 15.

ReferenceCitation: Mendoza M, Garcia-Ruiz I, Maiz N, Rodo C, Garcia-Manau P, Serrano B, Lopez-Martinez RM, Balcells J, Fernandez-Hidalgo N, Carreras E, Suy A. Pre-eclampsia-like syndrome induced by severe COVID-19: a prospective observational study. BJOG. 2020 Oct;127(11):1374-1380. doi: 10.1111/1471-0528.16339. Epub 2020 Jun 21.

ReferenceCitation: Cosma S, Carosso AR, Cusato J, Borella F, Carosso M, Bovetti M, Filippini C, D'Avolio A, Ghisetti V, Di Perri G, Benedetto C. Coronavirus disease 2019 and first-trimester spontaneous abortion: a case-control study of 225 pregnant patients. Am J Obstet Gynecol. 2021 Apr;224(4):391.e1-391.e7. doi: 10.1016/j.ajog.2020.10.005. Epub 2020 Oct 8.

ipd_sharing: Undecided

lead_sponsor: Brugmann University Hospital

location_country: France Italy Belgium

location_facility: Fondazione Policlinico Universitario Agostino Gemelli


title: Evaluation of the Hypoallergenicity of a New Formula Based on Hydrolyzed Rice Proteins (TRHF 2017) in Children With Confirmed Immunoglobulin E (IgE) or Non-immunoglobulin E-mediated Cow's Milk Allergy (CMA)

summary: The aim of this study is to show the hypoallergenicity of a new thickened rice based formula (TRHF) through a double blind placebo controlled food challenge (DBPCFC), as recommended by the American Academy of Pediatrics, in subjects with IgE-mediated CMA and in subjects with non-IgE-mediated CMA.

lead_sponsor: United Pharmaceuticals

location_facility:
CHR Namur
University of Naples Federico II
Hopital Trousseau
Hôpital Saint Vincent de Paul - GHICL

intervention_type: Dietary Supplement


summary: The purpose of the MASS2 is to characterize accelerometer signals of Micra implantable device during different postures and activities and to understand the source of the sensed motion, in order to test feasibility for future enhancements in device functionalities.

primary_purpose: Health Services Research

ReferenceCitation: Chinitz L, Ritter P, Khelae SK, Iacopino S, Garweg C, Grazia-Bongiorni M, Neuzil P, Johansen JB, Mont L, Gonzalez E, Sagi V, Duray GZ, Clementy N, Sheldon T, Splett V, Stromberg K, Wood N, Steinwender C. Accelerometer-based atrioventricular synchronous pacing with a ventricular leadless pacemaker: Results from the Micra atrioventricular feasibility studies. Heart Rhythm. 2018 Sep;15(9):1363-1371. doi: 10.1016/j.hrthm.2018.05.004. Epub 2018 May 11.

lead_sponsor: Medtronic Cardiac Rhythm and Heart Failure

location_country: Austria France Spain

location_facility:
Hôpital cardiologique du Haut-Lévêque
Kepler Universitätsklinikum
Hospital Clinic
CHRU Tours - Hopital Trousseau


title: The Paradigm IIca/III Trial: PFx Closure System in Subjects With Cryptogenic Stroke, Transient Ischemic Attack, Migraine or Decompression Illness

summary: The primary objective of this study is to demonstrate the safety and performance of the PFx Closure System when utilized for patients with PFOs suffering from cryptogenic stroke, transient ischemic attack, migraine or decompression illness.

status: Suspended

lead_sponsor: Cierra

location_country: Germany France Belgium

location_facility: Cardiovascular Center Frankfurt Sankt katharinen


title: A Phase 2 Efficacy And Safety Study Of SU011248 Administered In A Continuous Daily Regimen In Patients With Advanced Gastrointestinal Stromal Tumor

summary: To evaluate the antitumor activity of SU011248 in advanced, imatinib mesylate-resistant gastrointestinal stromal tumor (GIST) when administered on a continuous daily dosing schedule

lead_sponsor: Pfizer

location_country:
United States
Italy
France


title: F2-PROTOCOL: Prospective Collection of Data of Possible Prognostic Relevance in Patients With Follicular Lymphoma

summary:
The F2-study is a complement of the previous studies of the Follicular Lymphoma Prognostic Factors Project which permitted the development of the Follicular Lymphoma International Prognostic Index (FLIPI).

The F2-study is designed as a prospective collection of information potentially useful to predict the prognosis of newly diagnosed Follicular Lymphoma patients, and its purposes are to validate the FLIPI and to verify whether a prognostic collection of data would allow the development of a more accurate prognostic index.

ReferenceCitation: Federico M, Bellei M, Pro B, Lopez-Guillermo A, Marcheselli L, Trneny M, Soubeyran P, MCLaughlin P, Pileri S, Solal-Céligny P on behalf of the F2 study. Revalidation of FLIPI in patients with Follicular Lymphoma (FL) registered in the F2 study and treated upfront with immunochemotherapy. J Clin Oncol 25(18s), 2007. Abstr 8008.

ReferenceCitation: Federico M, Bellei M, Marcheselli L, Luminari S, Lopez-Guillermo A, Vitolo U, Pro B, Martelli M, Soubeyran P, Cortelazzo S, Martinelli G, Pileri S, McLaughlin P, Solal-Céligny P on behalf of International Follicular Lymphoma Prognostic factor Project (IFLPFP) F2-study group. F2 prognostic index. Ann Oncol 19(suppl 4):101-102, 2008. Abstr 058.

ReferenceCitation: Federico M, Bellei M, Marcheselli L, Luminari S, Lopez-Guillermo A, Vitolo U, Pro B, Pileri S, Pulsoni A, Soubeyran P, Cortelazzo S, Martinelli G, Martelli M, Rigacci L, Arcaini L, Di Raimondo F, Merli F, Sabattini E, McLaughlin P, Solal-Céligny P. Follicular lymphoma international prognostic index 2: a new prognostic index for follicular lymphoma developed by the international follicular lymphoma prognostic factor project. J Clin Oncol. 2009 Sep 20;27(27):4555-62. doi: 10.1200/JCO.2008.21.3991. Epub 2009 Aug 3.

ReferenceCitation: Solal-Céligny P, Bellei M, Marcheselli L, Pesce EA, Pileri S, McLaughlin P, Luminari S, Pro B, Montoto S, Ferreri AJ, Deconinck E, Milpied N, Gordon LI, Federico M. Watchful waiting in low-tumor burden follicular lymphoma in the rituximab era: results of an F2-study database. J Clin Oncol. 2012 Nov 1;30(31):3848-53. doi: 10.1200/JCO.2010.33.4474. Epub 2012 Sep 24.

lead_sponsor: Associazione Angela Serra per la ricerca sul cancro

location_country:
Spain
Italy
United Kingdom
Argentina
Switzerland
United States
France
Czechia

location_facility: Ospedale Casa Sollievo della Sofferenza IRCCS

location_facility: Academia Nacional de Medicina - Oncohematology Department, Instituto de Investigaciones Hematologicas

location_facility: Ospedale E. Morelli - Divisione di Medicina Generale, Ematologia

location_facility: Azienda Ospedaliera Universitaria San Giovanni Battista

location_facility: Fondazione IRCCS Policlinico San Matteo - Clinica Ematologica

location_facility: Northwestern University Feinberg School of Medicine - Department of Hematology/Oncology

location_facility: Dipartimento di Oncologia, Ematologia e Patologie dell'Apparato Respiratorio, Univ. di Modena e Reggio Emilia - Oncologia II

location_facility: Centre Hospitalier Univeristaire - Hématologie clinique

location_facility: Azienda Ospedaliera Maggiore della Carità

location_facility: Centre Jean Bernard, Clinique Victor Hugo

location_facility: Institut Bergonié Comprehensive Cancer Center

location_facility: Ospedale Santo Spirito, USL di Pescara - Dipartimento di Oncologia

location_facility: Centro de Internacion e Investigacion Clinica "Angelica Ocampo" - Hematologia

location_facility: Institu Catala d'Oncologia - Servei d'Hematologia

location_facility: Ospedale civile Guglielmo da Saliceto - Medicina Oncologica ed Ematologica

location_facility: Ospedale Civile SS. Giovanni e Paolo - UO di Ematologia

location_facility: Azienda Ospedaliera Ospedali Riuniti Papardo-Piemonte

location_facility: Azienda Ospedaliera S. Carlo - Oncologia Medica

location_facility: Dipartimento di Oncologia, Ematologia e Patologie dell'Apparato Respiratorio, Univ. di Modena e Reggio Emilia - Ematologia

location_facility: Università la Sapienza, Dip. di Biotecnologie Cellulari ed Ematologia, Sez. Ematologia

location_facility: Hospital Universitario Vall de Hebron - Servei d'Hematologia Clinica

location_facility: Hospital Clinic - Institut d'Hematologia i Oncologia

location_facility: Hopital caremeau - Service de Medecine Interne B

location_facility: Policlinico Universitario a gestione diretta - Divisione di Ematologia

location_facility: Hospital Universitari Germans Trias i Pujol - Institut Català d'Oncologia

location_facility: Charles University General Hospital - Ist Dept Medicine

location_facility: Istituto Scientifico Universitario San Raffaele

location_facility: Ospedale San Vincenzo - Ematologia e Immunologia

location_facility: Azienda Ospedaliera Sant'Andrea - UOC Ematologia

location_facility: Centre Hospitalier Universitaire - Hématologie

location_facility: Ospedale unico Versilia USL 12 - Divisione di Medicina II, DH Oncoematologico

location_facility: Dipartimento di Oncologia, Ematologia e Patologie dell'Apparato Respiratorio, Univ. di Modena e Reggio Emilia - Medicina Interna

location_facility: Azienda O.U. Vittorio Emanuele-Ferrarotto-S. Bambino

location_facility: Policlinico Monteluce - Divisione di Clinica Medica

location_facility: Azienda Ospedaliera Universitaria Pisana - UO di Ematologia


title: A Phase 3, Multicenter, Randomized, Double-blind, Active Comparator-Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Adults Living With HIV

summary: This study will evaluate the safety, tolerability, and immunogenicity of a pneumococcal 21-valent conjugate vaccine (V116) in persons living with human immunodeficiency virus (HIV), for the prevention of pneumococcal disease caused by the serotypes in the vaccine.

primary_purpose: Prevention

lead_sponsor: Merck Sharp & Dohme LLC

location_country:
Belgium
Thailand
France
United States
Chile
South Africa

location_facility: Insituut voor tropische Geneeskunde ( Site 0501)

location_facility: Right To Care Research - Esizayo ( Site 0904)

location_facility: Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 0601)

location_facility: Hospital hernan henriquez aravena de temuco-Unidad de Investigación Clínica ( Site 0101)

location_facility: Universidad San Sebastian - Providencia ( Site 0111)

location_facility: Perinatal HIV Research Unit (PHRU)-Adult Treatment and Research ( Site 0906)

location_facility: Research Institute for Health Sciences-Research Institute for Health Sciences Building 1 ( Site 1101

location_facility: North Texas Infectious Diseases Consultants, P.A ( Site 0001)

location_facility: Faculty of Medicine Siriraj Hospital-Preventive and social ( Site 1100)

location_facility: Texas Center for Infectious Disease Associates ( Site 0011)

location_facility: Midway Immunology and Research Center ( Site 0003)


title: A Phase 2 Study of Pembrolizumab (MK-3475) Every 6 Weeks (Q6W) in Participants With Relapsed or Refractory Classical Hodgkin's Lymphoma (rrcHL) or Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL)

summary: The primary objective of the study is to evaluate the objective response rate (ORR), by cohort, rrcHL and rrPMBCL, as assessed by the investigator according to Lugano classification criteria 2014 in participants treated with pembrolizumab Q6W.

status: Active, not recruiting

location_country:
Poland
Brazil
Italy
Russian Federation
Canada
Ukraine
France
United States
Turkey
South Africa
Czechia

location_facility: Ege University Medicine of Faculty ( Site 1105)

location_facility: Fundação Pio XII - Hospital de Câncer de Barretos ( Site 1701)

location_facility: Almazov National Medical Research Centre ( Site 0807)

location_facility: The National Medico-Surgical Center N.I. Pirogov ( Site 0801)

location_facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 0503)

location_facility: CNPE Regional Center of Oncology ( Site 1305)

location_facility: Fakultni nemocnice Hradec Kralove-IV. interni hematologicka klinika ( Site 0304)

location_facility: Fondazione IRCCS Policlinico San Matteo ( Site 0509)

location_facility: Moscow City Clinical Hospital S.P. Botkin ( Site 0803)

location_facility: Ankara University Department of Hematology, Clinical Research Unit ( Site 1101)

location_facility: Szpital Kliniczny im. Przemienienia Panskiego Uniwersytetu M-Oddzial Hematologii i Transplantacji S

location_facility: Lundquist Institute for Biomedical Innovation at Harbor-UCLA-Hematology and Medical Oncology ( Site

location_facility: Az. Osp. Ospedali Riuniti VILLA SOFIA-CERVELLO-EMATOLOGIA I ( Site 0507)

location_facility: Netcare Pretoria East Hospital-Albert Alberts Stem Cell Transplant Centre ( Site 0902)

location_facility: Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand ( Site 0401)

location_facility: Fakultni nemocnice Brno Bohunice-Interni hematologicka a onkologicka klinika ( Site 0302)

location_facility: Fakultni nemocnice Kralovske Vinohrady-Interni hematologicka klinika ( Site 0303)

location_facility: Anne Arundel Medical Center-Anne Arundel Oncology and Hematology ( Site 0125)

location_facility: Uniwersyteckie Centrum Kliniczne-Klinika Hematologii i Transplantologii ( Site 0063)


title: A Multicenter, Open-Label, Extension Study Intended to Evaluate the Long-term Safety of Ecopipam Tablets in Children and Adolescent Subjects With Tourette's Syndrome

summary: This study is an international, multicenter, open-label, long term extension study evaluating the safety of ecopipam tablets for the treatment of children and adolescent subjects with Tourette Syndrome.

lead_sponsor: Emalex Biosciences Inc.

location_country:
Poland
Italy
Canada
Hungary
United States
France
Germany

location_facility: Eastside Therapeutic Resource Inc dba Core Clinical Research

location_facility: Azienda Ospedaliero-Universitaria di Cagliari

location_facility: Zentralinstitut fuer Seelische Gesundheit

location_facility: NZOZ Wielospecjalistyczna Poradnia Lekarska Synapsis

location_facility: Cincinnati Childrens Hospital Medical Center

location_facility: Centrum Bada Klinicznych PI-House Sp. z o.o.

location_facility: St. Charles Psychiatric Associates dba Midwest Research Group

location_facility: Dept. Child Adolescent Psychiatry Uni. Freiburg

location_facility: Pharmakologisches Studienzentrum Chemnitz GmbH

location_facility: Pediatric Epilepsy and Neurology Specialists

location_facility: Helen DeVos Children's Hospital / Spectrum Health Medical Group

location_facility: Vadaskert Alapitvany a Gyermekek Lelki Egeszsegeert

location_facility: University Hospitals Cleveland Medical Center

location_facility: Northwest Florida Clinical Research Group, LLC

location_facility: Department of Psychiatry, Socialpsychiatry and Psychotherapy, Hannover Medical School

location_facility: Ospedaliera Universitaria Policlinico Umberto I

location_facility: Wojewdzki Specjalistyczny Szpital Dziecicy im. sw. Ludwika w Krakowie

location_facility: Psychiatric Clinic of Ludwig Maximilians Universitaet Muenchen

location_facility: Center for Psychiatry and Behavioral Medicine Inc.

location_facility: Azienda Ospedaliera Vittorio Emanuele Policlinico


title: Multicenter, Placebo-Controlled, Double-Blind, Randomized, Parallel-Group, Phase 2b Study to Evaluate the Efficacy and Safety of Ecopipam in Children and Adolescents With Tourette's Syndrome

location_country:
Poland
Canada
United States
France
Germany

location_facility: Eastside Therapeutic Resource Inc dba Core Clinical Research

location_facility: NZOZ Wielospecjalistyczna Poradnia Lekarska Synapsis

location_facility: Zentralinstitut fuer Seelische Gesundheit

summary: This study evaluates the effect of ecopipam tablets in children and adolescents in the treatment of Tourette's Syndrome (TS). Half of the participants will receive ecopipam tablets, while the other half will receive matching placebo tablets


title: Physiologic Pacing Registry

summary: The Physiologic Pacing Registry is a prospective, observational, multi-center registry performed to gain a broader understanding of 1) physiologic pacing implant and follow-up workflows, including pacing and sensing measurements and 2) the clinical utility in creating a 3-dimensional electro-anatomical map of cardiac structures prior to physiologic pacing device implants based on the clinical site's routine care.

lead_sponsor: Abbott Medical Devices

location_country:
Poland
Hong Kong
Spain
Italy
Austria
Australia
Netherlands
Canada
Switzerland
United States
France
India
Singapore
South Africa
Germany
Czechia

location_facility: Gornoslaskie Centrum Medyczne im.prof. Leszka Gieca

location_facility: Donald Guthrie Foundation for Education and Research

location_facility: Hospital Universitario Virgen de la Nieves

location_facility: Asian Institute of Gastroenterology (AIG) Hospital

location_facility: University of Vermont College of Medicine

location_facility: University of California at San Diego (UCSD) Medical Center


acronym: PKAN

title: Efficacy, Safety, and Tolerability of Fosmetpantotenate (RE-024), a Phosphopantothenate Replacement Therapy, in Pantothenate Kinase-Associated Neurodegeneration (PKAN) Patients: A Randomized, Double-Blind, Placebo-Controlled Study With an Open-Label Extension

lead_sponsor: Travere Therapeutics, Inc.

ReferenceCitation: Klopstock T, Escolar ML, Marshall RD, Perez-Dueñas B, Tuller S, Videnovic A, Greblikas F. The FOsmetpantotenate Replacement Therapy (FORT) randomized, double-blind, Placebo-controlled pivotal trial: Study design and development methodology of a novel primary efficacy outcome in patients with pantothenate kinase-associated neurodegeneration. Clin Trials. 2019 Aug;16(4):410-418. doi: 10.1177/1740774519845673. Epub 2019 May 6.

location_country:
Poland
Spain
Italy
Canada
United States
France
Norway
Germany
Czechia

summary: This study investigated whether fosmetpantotenate (RE-024), a phosphopantothenate replacement therapy, was safe and effective in treating participants with PKAN.


title: A Phase 4, Double-blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety and Efficacy of Adalimumab Used in Conjunction With Surgery in Subjects With Moderate to Severe Hidradenitis Suppurativa

acronym: SHARPS

summary: The objective of this study was to assess the safety and efficacy of adalimumab prior to surgery in participants with moderate to severe Hidradenitis Suppurativa (HS) who were surgical candidates.

ReferenceCitation: Bechara FG, Podda M, Prens EP, Horváth B, Giamarellos-Bourboulis EJ, Alavi A, Szepietowski JC, Kirby J, Geng Z, Jean C, Jemec GBE, Zouboulis CC. Efficacy and Safety of Adalimumab in Conjunction With Surgery in Moderate to Severe Hidradenitis Suppurativa: The SHARPS Randomized Clinical Trial. JAMA Surg. 2021 Nov 1;156(11):1001-1009. doi: 10.1001/jamasurg.2021.3655.

ipd_sharing_description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

lead_sponsor: AbbVie

location_country:
Saudi Arabia
Italy
Spain
United Kingdom
United States
Belgium
Romania
Czechia
Poland
Portugal
Russian Federation
Turkey
Mexico
Norway
Sweden
Canada
Germany
Denmark
Greece
Ireland
France
Colombia
Netherlands

location_facility: NewLab Clinical Research Inc. /ID# 151315

location_facility: Staedtisches Klinikum Dessau /ID# 150876

location_facility: Genl Hospital Andreas Syggros /ID# 150840

location_facility: Fakult Nem Kralovske Vinohrady /ID# 169173

location_facility: Universitaetsklinikum Erlangen /ID# 167251

location_facility: Universitair Medisch Centrum Groningen /ID# 150662

location_facility: Centro Hospitalar de Sao Joao, EPE /ID# 150885

location_facility: Penn State Hershey Medical Ctr /ID# 168447

location_facility: Hospital General Universitario Gregorio Maranon /ID# 150788

location_facility: University of Michigan Hospitals /ID# 200667

location_facility: Spitalul Municipal de Urgenta Timisoara /ID# 151073

location_facility: Hospital Univ Germans Trias I Pujol /ID# 150787

location_facility: Prywatny Osrodek Chirurgii Plastycznej Andrzej Bieniek /ID# 169413

location_facility: York Dermatology Clinic and Research Centre /ID# 151314

location_facility: Policlinico Univ Tor Vergata /ID# 150142

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico /ID# 150069

location_facility: Encino Research Center / T. Jo /ID# 171347

location_facility: Uludag University Medical Faculty /ID# 150831

location_facility: Radboud Universitair Medisch Centrum /ID# 152157

location_facility: King Faisal Specialist Hospital and Research Centre /ID# 153769

location_facility: Spitalul Universitar de Urgenta Elias /ID# 151072

location_facility: Haukeland University Hospital /ID# 152662

location_facility: Charité Universitätsmedizin Campus Mitte /ID# 150875

location_facility: St Vincent's University Hosp /ID# 150043

location_facility: Corporac Sanitaria Parc Tauli /ID# 150789

location_facility: University General Hospital Attikon /ID# 150841

location_facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez /ID# 151027

location_facility: Sjaellands Universitets Hospit /ID# 150795

location_facility: Beth Israel Deaconess Medical Center /ID# 168438

location_facility: NW State Med Univ NA Mechnikov /ID# 151197

location_facility: Genl Hospital Andreas Syggros /ID# 150842

location_facility: Hospital Santa Creu i Sant Pau /ID# 152742

location_facility: Hacettepe University Medical Faculty /ID# 150829

location_facility: University of California Irvine /ID# 170054


acronym: CREDIBLE - CR

title: A Multicenter, Randomized, Open-label Clinical Study of S-649266 or Best Available Therapy for the Treatment of Severe Infections Caused by Carbapenem-resistant Gram-negative Pathogens

lead_sponsor: Shionogi

ReferenceCitation: Nordmann P, Shields RK, Doi Y, Takemura M, Echols R, Matsunaga Y, Yamano Y. Mechanisms of Reduced Susceptibility to Cefiderocol Among Isolates from the CREDIBLE-CR and APEKS-NP Clinical Trials. Microb Drug Resist. 2022 Apr;28(4):398-407. doi: 10.1089/mdr.2021.0180. Epub 2022 Jan 24.

ReferenceCitation: Wenzler E, Butler D, Tan X, Katsube T, Wajima T. Pharmacokinetics, Pharmacodynamics, and Dose Optimization of Cefiderocol during Continuous Renal Replacement Therapy. Clin Pharmacokinet. 2022 Apr;61(4):539-552. doi: 10.1007/s40262-021-01086-y. Epub 2021 Nov 18. Erratum in: Clin Pharmacokinet. 2022 Jul;61(7):1069.

ReferenceCitation: Naseer S, Weinstein EA, Rubin DB, Suvarna K, Wei X, Higgins K, Goodwin A, Jang SH, Iarikov D, Farley J, Nambiar S. US Food and Drug Administration (FDA): Benefit-Risk Considerations for Cefiderocol (Fetroja®). Clin Infect Dis. 2021 Jun 15;72(12):e1103-e1111. doi: 10.1093/cid/ciaa1799.

ReferenceCitation: Bassetti M, Echols R, Matsunaga Y, Ariyasu M, Doi Y, Ferrer R, Lodise TP, Naas T, Niki Y, Paterson DL, Portsmouth S, Torre-Cisneros J, Toyoizumi K, Wunderink RG, Nagata TD. Efficacy and safety of cefiderocol or best available therapy for the treatment of serious infections caused by carbapenem-resistant Gram-negative bacteria (CREDIBLE-CR): a randomised, open-label, multicentre, pathogen-focused, descriptive, phase 3 trial. Lancet Infect Dis. 2021 Feb;21(2):226-240. doi: 10.1016/S1473-3099(20)30796-9. Epub 2020 Oct 12.

ReferenceCitation: Bassetti M, Ariyasu M, Binkowitz B, Nagata TD, Echols RM, Matsunaga Y, Toyoizumi K, Doi Y. Designing A Pathogen-Focused Study To Address The High Unmet Medical Need Represented By Carbapenem-Resistant Gram-Negative Pathogens - The International, Multicenter, Randomized, Open-Label, Phase 3 CREDIBLE-CR Study. Infect Drug Resist. 2019 Nov 21;12:3607-3623. doi: 10.2147/IDR.S225553. eCollection 2019.

location_country:
Croatia
Taiwan
Brazil
Spain
Greece
Italy
United Kingdom
Thailand
Guatemala
Korea, Republic of
United States
France
Israel
Turkey
Japan
Germany

summary: This study is designed to provide evidence of efficacy of cefiderocol in the treatment of serious infections in adult patients caused by carbapenem-resistant Gram-negative pathogens.


title: A Phase 2, Open Label, Randomized, Dose Ranging, Safety, Efficacy, Pharmacokinetic and Pharmacodynamic Study of AG-348 in Adult Patients With Pyruvate Kinase Deficiency

lead_sponsor: Agios Pharmaceuticals, Inc.

ReferenceCitation: Grace RF, Rose C, Layton DM, Galactéros F, Barcellini W, Morton DH, van Beers EJ, Yaish H, Ravindranath Y, Kuo KHM, Sheth S, Kwiatkowski JL, Barbier AJ, Bodie S, Silver B, Hua L, Kung C, Hawkins P, Jouvin MH, Bowden C, Glader B. Safety and Efficacy of Mitapivat in Pyruvate Kinase Deficiency. N Engl J Med. 2019 Sep 5;381(10):933-944. doi: 10.1056/NEJMoa1902678.

ReferenceCitation: Rab MAE, Van Oirschot BA, Kosinski PA, Hixon J, Johnson K, Chubukov V, Dang L, Pasterkamp G, Van Straaten S, Van Solinge WW, Van Beers EJ, Kung C, Van Wijk R. AG-348 (Mitapivat), an allosteric activator of red blood cell pyruvate kinase, increases enzymatic activity, protein stability, and ATP levels over a broad range of PKLR genotypes. Haematologica. 2021 Jan 1;106(1):238-249. doi: 10.3324/haematol.2019.238865.

location_country:
United Kingdom
Italy
Canada
United States
France
Netherlands

location_facility: Wayne State University School of Medicine - Children's Hospital of Michigan

location_facility: UOC Oncoematologia Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: New York Presbyterian Hospital- Weil Cornell Medical College

location_facility: Children Hospital of Philadelphia (CHOP)

summary: Study AG348-C-003 is a multicenter study designed to evaluate the safety and efficacy of different dose levels of AG-348 (mitapivat) in participants with PK deficiency.


title: Multicenter Study of Metastatic Lung Tumors Targeted by Interventional Cryoablation Evaluation

acronym: SOLSTICE

summary: The purpose of this study is to evaluate the safety and efficacy of cryoablation therapy used to treat tumors in participants with pulmonary metastatic disease. This study is to enroll participants who will undergo cryoablation of at least 1 metastatic pulmonary tumor that is less than or equal to 3.5 centimeter (cm). Participants will be followed 24 months post their cryoablation procedure.

ReferenceCitation: Gillams A. Lung tumour ablation - where are we now? Cancer Imaging. 2008 Apr 22;8:116-7. doi: 10.1102/1470-7330.2008.0015.

ReferenceCitation: Ahmed A, Littrup P. Percutaneous cryotherapy of the thorax: safety considerations for complex cases. AJR Am J Roentgenol. 2006 Jun;186(6):1703-6.

ReferenceCitation: Kawamura M, Izumi Y, Tsukada N, Asakura K, Sugiura H, Yashiro H, Nakano K, Nakatsuka S, Kuribayashi S, Kobayashi K. Percutaneous cryoablation of small pulmonary malignant tumors under computed tomographic guidance with local anesthesia for nonsurgical candidates. J Thorac Cardiovasc Surg. 2006 May;131(5):1007-13.

ReferenceCitation: Asimakopoulos G, Beeson J, Evans J, Maiwand MO. Cryosurgery for malignant endobronchial tumors: analysis of outcome. Chest. 2005 Jun;127(6):2007-14.

ReferenceCitation: Wang H, Littrup PJ, Duan Y, Zhang Y, Feng H, Nie Z. Thoracic masses treated with percutaneous cryotherapy: initial experience with more than 200 procedures. Radiology. 2005 Apr;235(1):289-98.

ReferenceCitation: Inoue M, Nakatsuka S, Yashiro H, Ito N, Izumi Y, Yamauchi Y, Hashimoto K, Asakura K, Tsukada N, Kawamura M, Nomori H, Kuribayashi S. Percutaneous cryoablation of lung tumors: feasibility and safety. J Vasc Interv Radiol. 2012 Mar;23(3):295-302; quiz 305. doi: 10.1016/j.jvir.2011.11.019. Epub 2012 Jan 20.

ReferenceCitation: Yamauchi Y, Izumi Y, Kawamura M, Nakatsuka S, Yashiro H, Tsukada N, Inoue M, Asakura K, Nomori H. Percutaneous cryoablation of pulmonary metastases from colorectal cancer. PLoS One. 2011;6(11):e27086. doi: 10.1371/journal.pone.0027086. Epub 2011 Nov 9.

ReferenceCitation: Pusceddu C, Sotgia B, Fele RM, Melis L. CT-guided thin needles percutaneous cryoablation (PCA) in patients with primary and secondary lung tumors: a preliminary experience. Eur J Radiol. 2013 May;82(5):e246-53. doi: 10.1016/j.ejrad.2012.12.010. Epub 2013 Feb 8.

lead_sponsor: Boston Scientific Corporation

location_country:
United States
France

location_facility: State University of New York at Stony Brook

location_facility: Cancer Treatment Centers of America at Southeastern Regional Medical Center

location_facility: New York Presbyterian Hospital - Cornell Medical Center


title: European All-comers' Multicentric Prospective REGISTRY on LUMINOR© Drug Eluting Balloon in the Superficial Femoral Artery and Popliteal Artery With 5 Years Follow-up.

acronym: LUMIFOLLOW

summary: The objective of this all-comers registry is to explore the safety, efficacy, and cost-efficiency of the LUMINOR© DEB in de-novo and restenotic-FP lesions. For de-novo and restenotic lesions, especially for calcified and/or long lesions/occlusions, the use of debulking devices to improve recalibration and drug penetration will be evaluated in a specific sub-group.

lead_sponsor: iVascular S.L.U.

location_facility: Centre Hospitalier Régional Universitaire Morvan de Brest

location_facility: Centre Hospitalier Universitaire Pellegrin


title: Randomized, Double-blind, Placebo-controlled Study With Open-label Extension Phase to Evaluate the Efficacy and Safety of Avatrombopag for the Treatment of Thrombocytopenia in Pediatric Subjects With Immune Thrombocytopenia for ≥6 Months

summary: A Phase 3b Study to Evaluate the Efficacy and Safety of Avatrombopag for the Treatment of Thrombocytopenia in Pediatric Subjects with Immune Thrombocytopenia for ≥6 Months

lead_sponsor: Sobi, Inc.

location_country:
Poland
United Kingdom
Russian Federation
Ukraine
Hungary
United States
France
Turkey
Germany

location_facility:
Site 502
Site 701
Site 120
Site 304
Site 504
Site 952
Site 702
Site 113
Site 115
Site 104
Site 709
Site 102
Site 112
Site 118
Site 301
Site 904
Site 710
Site 801
Site 103
Site 110
Site 954
Site 402
Site 406
Site 107
Site 106
Site 905
Site 802
Site 902
Site 903
Site 706
Site 703
Site 503
Site 405
Site 302
Site 705
Site 101
Site 407
Site 116
Site 501
Site 901
Site 708
Site 906
Site 401
Site 121
Site 410
Site 119
Site 114
Site 303
Site 117
Site 408
Site 704
Site 403
Site 202
Site 907
Site 105
Site 109
Site 201
Site 707
Site 803
Site 108
Site 505
Site 111


title: A Phase 1b Study Evaluating the Safety and Pharmacokinetics of ABT-199 in Relapsed or Refractory Multiple Myeloma Subjects Who Are Receiving Bortezomib and Dexamethasone as Their Standard Therapy

summary: The primary objectives of this study are to assess the safety profile, characterize pharmacokinetics (PK) and determine the dosing schedule, maximum tolerated dose (MTD), and the recommended phase two dose (RPTD) of ABT-199 when administered in subjects with relapsed /refactory multiple myeloma who are receiving bortezomib and dexamethasone as their standard therapy.

ReferenceCitation: Moreau P, Chanan-Khan A, Roberts AW, Agarwal AB, Facon T, Kumar S, Touzeau C, Punnoose EA, Cordero J, Munasinghe W, Jia J, Salem AH, Freise KJ, Leverson JD, Enschede SH, Ross JA, Maciag PC, Verdugo M, Harrison SJ. Promising efficacy and acceptable safety of venetoclax plus bortezomib and dexamethasone in relapsed/refractory MM. Blood. 2017 Nov 30;130(22):2392-2400. doi: 10.1182/blood-2017-06-788323. Epub 2017 Aug 28.

ReferenceCitation: Matulis SM, Gupta VA, Nooka AK, Hollen HV, Kaufman JL, Lonial S, Boise LH. Dexamethasone treatment promotes Bcl-2 dependence in multiple myeloma resulting in sensitivity to venetoclax. Leukemia. 2016 May;30(5):1086-93. doi: 10.1038/leu.2015.350. Epub 2015 Dec 28.

location_country:
Australia
United States
France

location_facility: University of Arizona Cancer Center - North Campus /ID# 117876

location_facility: CHU de Nantes, Hotel Dieu -HME /ID# 78773

location_facility: CHRU Lille - Hôpital Claude Huriez /ID# 77234

location_facility: University of Michigan Hospitals /ID# 80353

location_facility: Northwestern University Feinberg School of Medicine /ID# 117477


title: Observational Study to Evaluate Clinical Practice and Satisfaction With Metvix® Daylight Photodynamic Therapy (PDT) in the Treatment of Mild and/or Moderate Actinic Keratosis of the Face and/or the Scalp

acronym: SESAME

summary: Prospective non-interventional study conducted in Australia, Brazil, Mexico and Europe to evaluate clinical practice with Metvix Daylight PDT in the treatment of mild to moderate actinic keratosis of the face/scalp and to assess physician and patient satisfaction.

ReferenceCitation: See JA, Gebauer K, Wu JK, Manoharan S, Kerrouche N, Sullivan J. High Patient Satisfaction with Daylight-Activated Methyl Aminolevulinate Cream in the Treatment of Multiple Actinic Keratoses: Results of an Observational Study in Australia. Dermatol Ther (Heidelb). 2017 Dec;7(4):525-533. doi: 10.1007/s13555-017-0199-9. Epub 2017 Sep 13.

lead_sponsor: Galderma R&D

location_country:
Spain
Italy
United Kingdom
Australia
Switzerland
France
Netherlands

location_facility:
Bern
Italy
See Jo-Ann
France
Manchester
Madrid
Alkmaar


title: INGEVITY(TM) Active Fixation and Passive Fixation Pace/ Sense Lead Clinical Study

summary: The objective of this study is to gather data to establish the safety, performance and effectiveness of the INGEVITY pace/ sense leads.

location_country:
Denmark
Hong Kong
Portugal
Spain
Italy
Austria
Australia
United Kingdom
Canada
Thailand
Sweden
United States
France
Malaysia
Belgium
Germany

location_facility: Cardiology Associates of Fairfield County

location_facility: University of Iowa Hospitals and Clinics

location_facility: Kardiologische Gemeinschaftspraxis Kaltofen Schubert Gerner

location_facility: Hopital Hotel Dieu du Centre Hospitalier de l'Universite de Montreal

location_facility: Centro Hospitalar do Porto - Hospital de Santo Antonio

location_facility: Lindner Center for Research and Education at Christ Hosp

location_facility: Azienda Ospedaliera Universitaria Integrata di Verona

location_facility: Indiana University Health La Porte Hospital

location_facility: Chiang Mai Heart Center Medical School Hospital

location_facility: Hospital Universitario Nuestra Senora de Candelaria

location_facility: Cardiovascular Associates of the Delaware Valley

location_facility: Basildon and Thurrock University Hospitals NHS


title: A Phase 1, Multicentre, Open-label, Dose-escalation Study to Determine a Recommended Clinical Dose (RCD) of DT 9081, Followed by an Expansion Study of DT-9081 at RCD in Participants With Advanced, Recurrent or Metastatic Solid Tumours

acronym: EPRAD

summary: This is a Phase 1, multicentre, open-label, dose-escalation study to determine a recommended clinical dose (RCD) of DT-9081, followed by an expansion study of DT-9081 at RCD in participants with advanced, recurrent or metastatic solid tumours

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: Domain Therapeutics SA

location_country: France Belgium

location_facility:
Institut Claudius Regaud
Université Catholique de Louvain
Institut Curie
Institut Jules Bordet


title: A Phase 1, Open-Label Study to Assess the Pharmacokinetics, and Safety and Tolerability of a Single Intravenous Injection of rFVIIIFc-VWF-XTEN (BIVV001) in Adults With Type 2N and 3 Von Willebrand Disease (VWD)

summary:
Primary Objective:

-To characterize the pharmacokinetics (PK) of BIVV001 after a single intravenous (IV) administration, as assessed by factor VIII (FVIII) activity determined by the one-stage activated partial thromboplastin time (aPPT) clotting assay, as well as, BIVV001 capture chromogenic Coatest FVIII activity assay

Secondary Objective:

-To assess the safety and tolerability of a single IV dose of BIVV001 in adult patients with type 2N and 3 VWD

ipd_sharing_description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

lead_sponsor: Bioverativ, a Sanofi company

location_facility: University of Iowa_Investigational Site Number :8400002

location_facility: Hemophilia Center of Western Pennsylvania_Investigational Site Number :8400001


title: A Phase 1b Trial of LY2606368 in Combination With Chemoradiation in Patients With Locally Advanced Head and Neck Squamous Cell Cancer

summary: The main purpose of this study is to investigate the safety of prexasertib in combination with other anti-cancer drugs (cisplatin or cetuximab) and radiation therapy in participants with locally advanced head and neck cancer. The study has two parts (A and B). Participants will only enroll in one part.

ReferenceCitation: Zeng L, Nikolaev A, Xing C, Della Manna DL, Yang ES. CHK1/2 Inhibitor Prexasertib Suppresses NOTCH Signaling and Enhances Cytotoxicity of Cisplatin and Radiation in Head and Neck Squamous Cell Carcinoma. Mol Cancer Ther. 2020 Jun;19(6):1279-1288. doi: 10.1158/1535-7163.MCT-19-0946. Epub 2020 May 5.

ReferenceCitation: Zeng L, Beggs RR, Cooper TS, Weaver AN, Yang ES. Combining Chk1/2 Inhibition with Cetuximab and Radiation Enhances In Vitro and In Vivo Cytotoxicity in Head and Neck Squamous Cell Carcinoma. Mol Cancer Ther. 2017 Apr;16(4):591-600. doi: 10.1158/1535-7163.MCT-16-0352. Epub 2017 Jan 30.

lead_sponsor: Eli Lilly and Company

location_facility: University of Texas MD Anderson Cancer Center

location_facility: University of Alabama at Birmingham Medical Center


title: Determinants of the Progression and Outcome of Mitral Regurgitation-PROGRAM STUDY

acronym: PROGRAM

summary: Mitral regurgitation (MR) is one of the most frequent valve lesions, both in North America and in Europe, and its prevalence is increasing with the aging of the population. Organic Mitral Regurgitation (OMR) and Ischemic Mitral Regurgitation are the 2 main categories of MR. Organic or primary MR is caused by an anatomic alteration of the valvular or subvalvular mitral apparatus and refers to rheumatic MR and degenerative MR that includes mitral leaflet prolapse and flail leaflet. In the past 20 years, degenerative MR has become, by far, the most frequent cause of severe MR leading to surgery in the western world. However, the best current treatment for OMR remains uncertain and controversial. We have obtained preliminary data showing that OMR is a dynamic lesion. Hence, the echocardiographic evaluation of MR at rest, as generally performed during routine clinical exam, does not necessarily reflect the status of MR during patient's daily activities and thereby does not adequately assess the risk of rapid progression and poor outcome in these patients. The objective of this study is to identify the independent predictors of disease progression and outcome in patients with asymptomatic chronic OMR and to develop and validate novel imaging and circulating biomarkers to improve risk stratification and therapeutic decision-making process in patients with chronic asymptomatic primary OMR.

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ReferenceCitation: Magne J, Lancellotti P, Piérard LA. Exercise-induced changes in degenerative mitral regurgitation. J Am Coll Cardiol. 2010 Jul 20;56(4):300-9. doi: 10.1016/j.jacc.2009.12.073.

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ReferenceCitation: Mascle S, Schnell F, Thebault C, Corbineau H, Laurent M, Hamonic S, Veillard D, Mabo P, Leguerrier A, Donal E. Predictive value of global longitudinal strain in a surgical population of organic mitral regurgitation. J Am Soc Echocardiogr. 2012 Jul;25(7):766-72. doi: 10.1016/j.echo.2012.04.009. Epub 2012 May 19.

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ReferenceCitation: Magne J, Mahjoub H, Dulgheru R, Pibarot P, Pierard LA, Lancellotti P. Left ventricular contractile reserve in asymptomatic primary mitral regurgitation. Eur Heart J. 2014 Jun 21;35(24):1608-16. doi: 10.1093/eurheartj/eht345. Epub 2013 Sep 7.

ReferenceCitation: Toubal O, Mahjoub H, Thébault C, Clavel MA, Dahou A, Magne J, O'Connor K, Beaudoin J, Bernier M, Le Ven F, Pibarot P. Increasing Pulmonary Arterial Pressure at Low Level of Exercise in Asymptomatic, Organic Mitral Regurgitation. J Am Coll Cardiol. 2018 Feb 13;71(6):700-701. doi: 10.1016/j.jacc.2017.11.062.

ReferenceCitation: Clemenceau A, Bérubé JC, Bélanger P, Gaudreault N, Lamontagne M, Toubal O, Clavel MA, Capoulade R, Mathieu P, Pibarot P, Bosse Y. Deleterious variants in DCHS1 are prevalent in sporadic cases of mitral valve prolapse. Mol Genet Genomic Med. 2018 Jan;6(1):114-120. doi: 10.1002/mgg3.347. Epub 2017 Dec 10.

ReferenceCitation: Dupuis M, Mahjoub H, Clavel MA, Côté N, Toubal O, Tastet L, Dumesnil JG, O'Connor K, Dahou A, Thébault C, Bélanger C, Beaudoin J, Arsenault M, Bernier M, Pibarot P. Forward Left Ventricular Ejection Fraction: A Simple Risk Marker in Patients With Primary Mitral Regurgitation. J Am Heart Assoc. 2017 Oct 27;6(11). pii: e006309. doi: 10.1161/JAHA.117.006309.

lead_sponsor: Laval University

location_country: Canada France Belgium

location_facility: Institut Universitaire de Cardiologie et de Pneumologie de Québec

location_facility: University Hospital (CHU) of Brest, Hôpital La Cavale Blanche


title: A Double-blind, Placebo Controlled, Randomized, Phase IIa Study to Assess the Safety, Tolerability, Efficacy, and Pharmacokinetics of Repeated Topical Applications Over 42 Days of AP611074 5% Gel in Condyloma Patients

summary: The purpose of this study is to determine the safety, tolerability and efficacy of the topical application of AP611074 5% gel during 6 weeks on ano-genital warts caused by human papillomavirus (HPV).

lead_sponsor: Anaconda Pharma

location_country: Argentina France

location_facility: Hospotal Italinao de Buenos Aires - Dept of Dermatology and Gynecology

location_facility: IADT - Instituto Argentino de Diagnostico y Tratamiento S.A.

location_facility: Hopital Henri Mondor-Dept of Dermatology


title: A Phase I, Open-label, Multi-centre, Multiple Ascending Dose Study to Assess the Safety and Tolerability of AZD1152 in Combination With Low Dose Cytosine Arabinoside (LDAC) in Patients With Acute Myeloid Leukaemia (AML)

summary: A study to assess the safety and tolerability of AZD1152 in combination with low dose cytosine arabinoside (LDAC) in patients with acute myeloid leukaemia (AML). The first three patients to complete a 28 day cycle in the cohort, before the second three patients start treatment.

ReferenceCitation: Kantarjian HM, Sekeres MA, Ribrag V, Rousselot P, Garcia-Manero G, Jabbour EJ, Owen K, Stockman PK, Oliver SD. Phase I study assessing the safety and tolerability of barasertib (AZD1152) with low-dose cytosine arabinoside in elderly patients with AML. Clin Lymphoma Myeloma Leuk. 2013 Oct;13(5):559-67. doi: 10.1016/j.clml.2013.03.019. Epub 2013 Jun 10.

ReferenceCitation: Quintás-Cardama A, Ravandi F, Liu-Dumlao T, Brandt M, Faderl S, Pierce S, Borthakur G, Garcia-Manero G, Cortes J, Kantarjian H. Epigenetic therapy is associated with similar survival compared with intensive chemotherapy in older patients with newly diagnosed acute myeloid leukemia. Blood. 2012 Dec 6;120(24):4840-5. doi: 10.1182/blood-2012-06-436055. Epub 2012 Oct 15.

lead_sponsor: AstraZeneca


title: An Exploratory Phase II Study of PHA-739358 in Patients With Multiple Myeloma Harbouring the t(4;14) Translocation With or Without FGFR3 Expression

summary: The purpose of this study is to determine the antitumor activity of PHA-739358 as single agent IV infusion in adult patients with Multiple Myeloma who have a history of at least 2 previous lines of treatment for the disease.

primary_purpose: Supportive Care

lead_sponsor: Nerviano Medical Sciences

location_facility: The Robert H Lurie Comprehensive Cancer Center, Northwestern University

location_facility: Hôpital Huriez, Centre Hospitalier Régional Universitaire de Lille


title: A Phase I Single Arm Dose Escalation Study of the Combination of Dasatinib (Sprycel®) With Lenalidomide (Revlimid®) and Dexamethasone in Subjects With Relapsed and/ or Refractory Multiple Myeloma

summary: The purpose of this study was to determine the safety and tolerability of dasatinib when given in combination with lenalidomide and a low dose dexamethasone for the treatment of relapsed or refractory multiple myeloma.

lead_sponsor: Bristol-Myers Squibb

location_facility:
Local Institution
Mayo Clinic Arizona


title: A Phase I Study to Determine the Safety, Pharmacokinetics and Pharmacodynamics of BMS-690514 in Combination With FOLFIRI and FOLFOX in Subjects With Advanced Metastatic Solid Tumors

summary: The purpose of this research study is to determine the highest dose of BMS-690514 that can be safely given in combination with the chemotherapeutic regimens (FOLFIRI and FOLFOX) to patients with advanced cancer

location_facility:
Local Institution
University Of Alabama At Birmingham
Fox Chase Cancer Center


title: A Phase 2 Study of TAS-117 in Patients With Advanced Solid Tumors Harboring Germline PTEN Inactivating Mutations

lead_sponsor: Taiho Oncology, Inc.

ReferenceCitation: Rodón J, Funchain P, Laetsch TW, Arkenau HT, Hervieu A, Singer CF, Murciano-Goroff YR, Chawla SP, Anthony K, Yamamiya I, Liu M, Halim AB, Benhadji KA, Takahashi O, Delaloge S. A phase II study of TAS-117 in patients with advanced solid tumors harboring germline PTEN-inactivating mutations. Future Oncol. 2022 Sep;18(30):3377-3387. doi: 10.2217/fon-2022-0305. Epub 2022 Aug 30. Review.

location_country:
Austria
United States
United Kingdom
France

location_facility: The University of Texas M.D. Anderson Cancer Center

location_facility: Cleveland Clinic Lerner Research Institute

summary: The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of TAS-117 in patients with advanced or metastatic solid tumors (excluding primary brain tumors) harboring germline PTEN inactivating mutations.