title: A Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Study to Compare the Safety and Efficacy of RAD001 Plus Best Supportive Care (BSC) Versus BSC Plus Placebo in Patients With Metastatic Carcinoma of the Kidney Which Has Progressed on VEGF Receptor Tyrosine Kinase Inhibitor

ReferenceCitation: Stein A, Bellmunt J, Escudier B, Kim D, Stergiopoulos SG, Mietlowski W, Motzer RJ; RECORD-1 Trial Study Group. Survival prediction in everolimus-treated patients with metastatic renal cell carcinoma incorporating tumor burden response in the RECORD-1 trial. Eur Urol. 2013 Dec;64(6):994-1002. doi: 10.1016/j.eururo.2012.11.032. Epub 2012 Nov 21.

ReferenceCitation: Stein A, Wang W, Carter AA, Chiparus O, Hollaender N, Kim H, Motzer RJ, Sarr C. Dynamic tumor modeling of the dose-response relationship for everolimus in metastatic renal cell carcinoma using data from the phase 3 RECORD-1 trial. BMC Cancer. 2012 Jul 23;12:311. doi: 10.1186/1471-2407-12-311.

ReferenceCitation: Oudard S, Thiam R, Fournier LS, Medioni J, Lamuraglia M, Scotte F, Fabre E, Kim D, Kpamegan E, Panneerselvam A, Cuenod CA. Optimisation of the tumour response threshold in patients treated with everolimus for metastatic renal cell carcinoma: analysis of response and progression-free survival in the RECORD-1 study. Eur J Cancer. 2012 Jul;48(10):1512-8. doi: 10.1016/j.ejca.2012.01.027. Epub 2012 Feb 16.

ReferenceCitation: Porta C, Calvo E, Climent MA, Vaishampayan U, Osanto S, Ravaud A, Bracarda S, Hutson TE, Escudier B, Grünwald V, Kim D, Panneerselvam A, Anak O, Motzer RJ. Efficacy and safety of everolimus in elderly patients with metastatic renal cell carcinoma: an exploratory analysis of the outcomes of elderly patients in the RECORD-1 Trial. Eur Urol. 2012 Apr;61(4):826-33. doi: 10.1016/j.eururo.2011.12.057. Epub 2012 Jan 5.

ReferenceCitation: Calvo E, Escudier B, Motzer RJ, Oudard S, Hutson TE, Porta C, Bracarda S, Grünwald V, Thompson JA, Ravaud A, Kim D, Panneerselvam A, Anak O, Figlin RA. Everolimus in metastatic renal cell carcinoma: Subgroup analysis of patients with 1 or 2 previous vascular endothelial growth factor receptor-tyrosine kinase inhibitor therapies enrolled in the phase III RECORD-1 study. Eur J Cancer. 2012 Feb;48(3):333-9. doi: 10.1016/j.ejca.2011.11.027. Epub 2011 Dec 30.

ReferenceCitation: White DA, Camus P, Endo M, Escudier B, Calvo E, Akaza H, Uemura H, Kpamegan E, Kay A, Robson M, Ravaud A, Motzer RJ. Noninfectious pneumonitis after everolimus therapy for advanced renal cell carcinoma. Am J Respir Crit Care Med. 2010 Aug 1;182(3):396-403. doi: 10.1164/rccm.200911-1720OC. Epub 2010 Mar 1.

ReferenceCitation: Motzer RJ, Escudier B, Oudard S, Hutson TE, Porta C, Bracarda S, Grünwald V, Thompson JA, Figlin RA, Hollaender N, Urbanowitz G, Berg WJ, Kay A, Lebwohl D, Ravaud A; RECORD-1 Study Group. Efficacy of everolimus in advanced renal cell carcinoma: a double-blind, randomised, placebo-controlled phase III trial. Lancet. 2008 Aug 9;372(9637):449-56. doi: 10.1016/S0140-6736(08)61039-9. Epub 2008 Jul 22.

location_country:
Poland
Spain
Italy
Australia
Netherlands
Canada
United States
France
Japan
Germany

summary: To assess whether daily treatment with RAD001 could slow the growth and spread of metastatic carcinoma of the kidney. The safety of RAD001 was also to be studied in this trial.


title: A Randomised, Double-blind, Multicentre Phase II/III Study to Compare the Efficacy of Cediranib (RECENTIN™, AZD2171) in Combination With 5-fluorouracil, Leucovorin, and Oxaliplatin (FOLFOX), to the Efficacy of Bevacizumab in Combination With FOLFOX in Patients With Previously Untreated Metastatic Colorectal Cancer

acronym: HORIZON III

summary: The purpose of this study is to see if Cediranib in combination with FOLFOX is effective in treating metastatic colorectal cancer and to see how it compares with Avastin (Bevacizumab) in combination with FOLFOX.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Abdel-Rahman O. Effect of Body Mass Index on 5-FU-Based Chemotherapy Toxicity and Efficacy Among Patients With Metastatic Colorectal Cancer; A Pooled Analysis of 5 Randomized Trials. Clin Colorectal Cancer. 2019 Dec;18(4):e385-e393. doi: 10.1016/j.clcc.2019.07.005. Epub 2019 Jul 15.

ReferenceCitation: Abdel-Rahman O. Impact of Sex on Chemotherapy Toxicity and Efficacy Among Patients With Metastatic Colorectal Cancer: Pooled Analysis of 5 Randomized Trials. Clin Colorectal Cancer. 2019 Jun;18(2):110-115.e2. doi: 10.1016/j.clcc.2018.12.006. Epub 2018 Dec 28.

ReferenceCitation: Robertson JD, Botwood NA, Rothenberg ML, Schmoll HJ. Phase III trial of FOLFOX plus bevacizumab or cediranib (AZD2171) as first-line treatment of patients with metastatic colorectal cancer: HORIZON III. Clin Colorectal Cancer. 2009 Jan;8(1):59-60. doi: 10.3816/CCC.2009.n.010.

lead_sponsor: AstraZeneca

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Belgium
Philippines
South Africa
Poland
Austria
Australia
Russian Federation
India
Israel
Malta
Turkey
Slovakia
Egypt
Canada
Hungary
Germany
Taiwan
Latvia
Finland
Czech Republic
Thailand
Vietnam
France

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: A Randomized Phase 3 Trial of Alimta (Pemetrexed) and Carboplatin Versus Etoposide and Carboplatin in Extensive-Stage Small Cell Lung Cancer

summary: This study is a Phase 3, global, multi-center, open-label study of patients with extensive-stage small cell lung cancer. Eligible patients will be randomly assigned to receive either pemetrexed plus carboplatin or etoposide plus carboplatin. It is anticipated that pemetrexed plus carboplatin will offer similar survival benefits as compared to etoposide plus carboplatin.

ReferenceCitation: Socinski MA, Smit EF, Lorigan P, Konduri K, Reck M, Szczesna A, Blakely J, Serwatowski P, Karaseva NA, Ciuleanu T, Jassem J, Dediu M, Hong S, Visseren-Grul C, Hanauske AR, Obasaju CK, Guba SC, Thatcher N. Phase III study of pemetrexed plus carboplatin compared with etoposide plus carboplatin in chemotherapy-naive patients with extensive-stage small-cell lung cancer. J Clin Oncol. 2009 Oct 1;27(28):4787-92. doi: 10.1200/JCO.2009.23.1548. Epub 2009 Aug 31.

lead_sponsor: Eli Lilly and Company

location_country:
Spain
Italy
United Kingdom
United States
Romania
Belgium
South Africa
Poland
Portugal
Austria
Australia
Russian Federation
Argentina
Puerto Rico
India
Turkey
Brazil
Hungary
China
Germany
Taiwan
Greece
New Zealand
Korea, Republic of
France
Netherlands

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


title: A 16-week Randomised, Placebo-controlled, Double-blind, Double-dummy, Parallel-group Study Comparing the Efficacy and Safety of Tiotropium Inhalation Solution Delivered by the Respimat Inhaler (2 Actuations of 2.5 Mcg Once Daily) With That of Salmeterol From the Hydrofluoroalkane Metered Dose Inhaler (2 Actuations of 25 Mcg Twice Daily) in Moderate Persistent Asthma Patients With the B16-Arg/Arg Genotype

summary:
This is a 16 week multicentre, multinational, randomised, double-blind, double-dummy, placebo-controlled, parallel group study to evaluate the long-term efficacy and safety of tiotropium compared to salmeterol in moderate persistent asthmatic (GINA step 3) patients homozygous for arginine at the 16th amino acid position of the beta-adrenergic receptor (ADRB2). Following an initial 4-week run-in period on salmeterol MDI patients will be randomised into the 16 week double-blind treatment period in which they receive either tiotropium once daily administered from the Respimat inhaler or salmeterol twice daily administered from the hydrofluoro-alkane Metered Dose Inhaler (MDI), or placebo twice daily. After the 16 week treatment period all patients will receive salmeterol MDI twice daily for four weeks.

The patients perform daily morning and evening peak flow (PEF) and Forced Expiratory Volume in the First Second (FEV1) measurements with an electronic peak flow meter throughout the study. Daily data on asthma control and use of rescue medication are recorded using an electronic diary included in the electronic peak flow meter. On study visits the Mini-Asthma Quality of Life Questionnaire (Elizabeth Juniper) is administered, pulse and blood pressure and pre-dose pulmonary function testing (FEV1 and Forced Vital Capacity) are performed.

ReferenceCitation: Bateman ED, Kornmann O, Schmidt P, Pivovarova A, Engel M, Fabbri LM. Tiotropium is noninferior to salmeterol in maintaining improved lung function in B16-Arg/Arg patients with asthma. J Allergy Clin Immunol. 2011 Aug;128(2):315-22. doi: 10.1016/j.jaci.2011.06.004.

lead_sponsor: Boehringer Ingelheim

location_country:
Denmark
Spain
Greece
Austria
Italy
Russian Federation
Finland
United Kingdom
France
South Africa
Turkey
Belgium
Germany
Slovakia

location_facility: 205.342.42106 Boehringer Ingelheim Investigational Site

location_facility: 205.342.90006 Boehringer Ingelheim Investigational Site

location_facility: 205.342.45003 Boehringer Ingelheim Investigational Site

location_facility: 205.342.34008 Hospital Universitario Marqués de Valdecilla

location_facility: 205.342.07003 Boehringer Ingelheim Investigational Site

location_facility: 205.342.32006 Boehringer Ingelheim Investigational Site

location_facility: 205.342.39002 Università di Modena e Reggio Emilia

location_facility: 205.342.3307A Boehringer Ingelheim Investigational Site

location_facility: 205.342.30005 Boehringer Ingelheim Investigational Site

location_facility: 205.342.07004 Boehringer Ingelheim Investigational Site

location_facility: 205.342.34010 Hospital General Universitario de Valencia

location_facility: 205.342.32013 Boehringer Ingelheim Investigational Site

location_facility: 205.342.90001 Boehringer Ingelheim Investigational Site

location_facility: 205.342.49006 Boehringer Ingelheim Investigational Site

location_facility: 205.342.44003 Boehringer Ingelheim Investigational Site

location_facility: 205.342.49011 Boehringer Ingelheim Investigational Site

location_facility: 205.342.35802 Boehringer Ingelheim Investigational Site

location_facility: 205.342.49008 Boehringer Ingelheim Investigational Site

location_facility: 205.342.07005 Boehringer Ingelheim Investigational Site

location_facility: 205.342.32004 Boehringer Ingelheim Investigational Site

location_facility: 205.342.35803 Boehringer Ingelheim Investigational Site

location_facility: 205.342.45004 Boehringer Ingelheim Investigational Site

location_facility: 205.342.27001 Boehringer Ingelheim Investigational Site

location_facility: 205.342.3308B Boehringer Ingelheim Investigational Site

location_facility: 205.342.30002 Boehringer Ingelheim Investigational Site

location_facility: 205.342.49004 Boehringer Ingelheim Investigational Site

location_facility: 205.342.32011 Boehringer Ingelheim Investigational Site

location_facility: 205.342.39006 Azienda Ospedaliera Universitaria Careggi

location_facility: 205.342.44001 Boehringer Ingelheim Investigational Site

location_facility: 205.342.3308A Boehringer Ingelheim Investigational Site

location_facility: 205.342.43005 Boehringer Ingelheim Investigational Site

location_facility: 205.342.90005 Kocaeli Universitesi Tip Fakultesi

location_facility: 205.342.07002 Boehringer Ingelheim Investigational Site

location_facility: 205.342.32001 Boehringer Ingelheim Investigational Site

location_facility: 205.342.39009 Boehringer Ingelheim Investigational Site

location_facility: 205.342.42102 Boehringer Ingelheim Investigational Site

location_facility: 205.342.34009 Hospital Universio Puerta del Hierro

location_facility: 205.342.90007 Istanbul Universitesi Cerrahpasa Tip Fakultesi

location_facility: 205.342.42107 Boehringer Ingelheim Investigational Site

location_facility: 205.342.32005 Boehringer Ingelheim Investigational Site

location_facility: 205.342.30006 Boehringer Ingelheim Investigational Site

location_facility: 205.342.45001 Boehringer Ingelheim Investigational Site

location_facility: 205.342.44002 Boehringer Ingelheim Investigational Site

location_facility: 205.342.43007 Boehringer Ingelheim Investigational Site

location_facility: 205.342.32002 Boehringer Ingelheim Investigational Site

location_facility: 205.342.43001 Boehringer Ingelheim Investigational Site

location_facility: 205.342.30001 Boehringer Ingelheim Investigational Site

location_facility: 205.342.32010 Boehringer Ingelheim Investigational Site

location_facility: 205.342.49005 Boehringer Ingelheim Investigational Site

location_facility: 205.342.42101 Boehringer Ingelheim Investigational Site

location_facility: 205.342.49015 Boehringer Ingelheim Investigational Site

location_facility: 205.342.49002 Boehringer Ingelheim Investigational Site

location_facility: 205.342.27004 Boehringer Ingelheim Investigational Site

location_facility: 205.342.30004 Boehringer Ingelheim Investigational Site

location_facility: 205.342.45002 Boehringer Ingelheim Investigational Site

location_facility: 205.342.34003 Hospital Universitario La Paz

location_facility: 205.342.49009 Boehringer Ingelheim Investigational Site

location_facility: 205.342.27002 Boehringer Ingelheim Investigational Site

location_facility: 205.342.44006 Boehringer Ingelheim Investigational Site

location_facility: 205.342.3302A Hôpital Arnaud de Villeneuve

location_facility: 205.342.49003 Boehringer Ingelheim Investigational Site

location_facility: 205.342.43003 Boehringer Ingelheim Investigational Site

location_facility: 205.342.07007 Boehringer Ingelheim Investigational Site

location_facility: 205.342.49012 Boehringer Ingelheim Investigational Site

location_facility: 205.342.3305A Centre Hosp de la Cavale Blanche

location_facility: 205.342.32009 Boehringer Ingelheim Investigational Site

location_facility: 205.342.49007 Boehringer Ingelheim Investigational Site

location_facility: 205.342.42108 Boehringer Ingelheim Investigational Site

location_facility: 205.342.27007 Boehringer Ingelheim Investigational Site

location_facility: 205.342.32014 Boehringer Ingelheim Investigational Site

location_facility: 205.342.43002 Boehringer Ingelheim Investigational Site

location_facility: 205.342.35804 Boehringer Ingelheim Investigational Site

location_facility: 205.342.27008 Boehringer Ingelheim Investigational Site

location_facility: 205.342.35801 Boehringer Ingelheim Investigational Site

location_facility: 205.342.34011 Boehringer Ingelheim Investigational Site

location_facility: 205.342.42104 Boehringer Ingelheim Investigational Site

location_facility: 205.342.07008 Boehringer Ingelheim Investigational Site

location_facility: 205.342.30003 Boehringer Ingelheim Investigational Site

location_facility: 205.342.27003 Boehringer Ingelheim Investigational Site

location_facility: 205.342.34007 Hospital Universitari Arnau de Vilanova

location_facility: 205.342.49016 Boehringer Ingelheim Investigational Site

location_facility: 205.342.90003 Boehringer Ingelheim Investigational Site

location_facility: 205.342.42105 Boehringer Ingelheim Investigational Site

location_facility: 205.342.32003 Boehringer Ingelheim Investigational Site

location_facility: 205.342.39010 Boehringer Ingelheim Investigational Site

location_facility: 205.342.07001 Boehringer Ingelheim Investigational Site

location_facility: 205.342.34005 Hospital Vírgen de la Macarena

location_facility: 205.342.43006 Boehringer Ingelheim Investigational Site

location_facility: 205.342.32007 Boehringer Ingelheim Investigational Site

location_facility: 205.342.39003 Azienda Ospedaliera " S. Anna"

location_facility: 205.342.34006 Hospital Clinic i Provincial de Barcelona

location_facility: 205.342.07006 Boehringer Ingelheim Investigational Site

location_facility: 205.342.27005 Boehringer Ingelheim Investigational Site

location_facility: 205.342.43004 Boehringer Ingelheim Investigational Site

location_facility: 205.342.44005 Boehringer Ingelheim Investigational Site

location_facility: 205.342.32012 Boehringer Ingelheim Investigational Site

location_facility: 205.342.27006 Boehringer Ingelheim Investigational Site

location_facility: 205.342.49013 Boehringer Ingelheim Investigational Site

location_facility: 205.342.34002 Hospital de Gran Canaria Dr. Negrín

location_facility: 205.342.34004 Hospital General Universitario de Guadalajara

location_facility: 205.342.42103 Boehringer Ingelheim Investigational Site

location_facility: 205.342.49010 Boehringer Ingelheim Investigational Site

location_facility: 205.342.90004 Celal Bayar Universitesi Tip Fakultesi


type: EudraCT Number

title: A Randomised, Double Blind, Placebo Controlled, Multicentre Study to Evaluate the Efficacy and Safety of Bevacizumab in Combination With Docetaxel in Comparison With Docetaxel Plus Placebo, as First Line Treatment for Patients With HER2 Negative Metastatic and Locally Recurrent Breast Cancer.

summary: This study will evaluate the efficacy and safety of 2 doses of Avastin in combination with docetaxel, versus docetaxel plus placebo, in patients with metastatic HER2 negative breast cancer who are candidates for taxane-based chemotherapy but who have not received prior chemotherapy for metastatic disease. The anticipated time on treatment is 1-2 years and the target sample size is 500+ individuals.

ReferenceCitation: Wedam SB, Beaver JA, Amiri-Kordestani L, Bloomquist E, Tang S, Goldberg KB, Sridhara R, Ibrahim A, Kim G, Kluetz P, McKee A, Pazdur R. US Food and Drug Administration Pooled Analysis to Assess the Impact of Bone-Only Metastatic Breast Cancer on Clinical Trial Outcomes and Radiographic Assessments. J Clin Oncol. 2018 Apr 20;36(12):1225-1231. doi: 10.1200/JCO.2017.74.6917. Epub 2018 Mar 9.

lead_sponsor: Hoffmann-La Roche

location_country:
Spain
Italy
United Kingdom
Lithuania
Romania
South Africa
Belgium
Poland
Portugal
Austria
Australia
Panama
Mexico
Sweden
Brazil
Canada
Switzerland
China
Germany
Taiwan
Thailand
Korea, Republic of
France
Netherlands


title: Inhaled Pre-prandial Human Insulin With the AERx® iDMS Versus s.c. Insulin Aspart in Type 2 Diabetes: A 104 Week, Open-label, Multicenter, Randomised, Trial Followed by a 12 Week Re-randomised Extension to Investigate Safety and Efficacy

summary: This trial is conducted in Asia, Europe and South America. The aim of this research is to compare the efficacy (reduction in HbA1c and blood glucose) and pulmonary safety (pulmonary function tests, chest x-rays) of mealtime inhaled insulin with subcutaneous insulin aspart both in combination with insulin detemir in Type 2 Diabetes.

status: Terminated

lead_sponsor: Novo Nordisk A/S

location_country:
Denmark
Taiwan
Hong Kong
Brazil
Spain
Italy
United Kingdom
France
Israel
Singapore
Germany

status_simplified: Unknown


title: A Multicenter, Randomized, Open Label Dose Finding Study of Mircera in Anemic Patients With Stage IIIB or IV Non-small Cell Lung Cancer Receiving First Line Myelosuppressive Chemotherapy

summary: This 4 arm study will assess the optimal starting dose of Mircera in the treatment of anemia in patients with non-small cell lung cancer receiving first line myelosuppressive chemotherapy. Patients will be randomized to receive either Mircera 6.3 micrograms/kg, 9 micrograms/kg or 12 micrograms/kg s.c. every 3 weeks or darbepoetin alfa according to the approved local label (either 6.75 micrograms/kg s.c. every 3 weeks, or 2.25 micrograms/kg every week). The anticipated time on study treatment is <3 months and the target sample size is 100-500 individuals.

location_country:
Poland
Hong Kong
Spain
Greece
Austria
Australia
Estonia
Canada
Czech Republic
Finland
Italy
Hungary
France
Belgium
Germany


title: A Multi-center, Randomized, Double-Blind, Two-Arm, Phase III Study in Patients With Untreated Stage III (Unresectable) or IV Melanoma Receiving Dacarbazine Plus 10 mg/kg Ipilimumab (MDX-010) vs. Dacarbazine With Placebo

summary: The purpose of this clinical research study is to examine the safety and effectiveness (how well the drug works) of two different treatments for patients with melanoma. One treatment is an investigational compound (a drug that is not currently approved by the United States Food and Drug Administration [FDA]), know as Ipilimumab (also known as MDX-010 or BMS-734016) together with an approved chemotherapy drug called Dacarbazine

ReferenceCitation: Maio M, Grob JJ, Aamdal S, Bondarenko I, Robert C, Thomas L, Garbe C, Chiarion-Sileni V, Testori A, Chen TT, Tschaika M, Wolchok JD. Five-year survival rates for treatment-naive patients with advanced melanoma who received ipilimumab plus dacarbazine in a phase III trial. J Clin Oncol. 2015 Apr 1;33(10):1191-6. doi: 10.1200/JCO.2014.56.6018. Epub 2015 Feb 23.

ReferenceCitation: Schadendorf D, Hodi FS, Robert C, Weber JS, Margolin K, Hamid O, Patt D, Chen TT, Berman DM, Wolchok JD. Pooled Analysis of Long-Term Survival Data From Phase II and Phase III Trials of Ipilimumab in Unresectable or Metastatic Melanoma. J Clin Oncol. 2015 Jun 10;33(17):1889-94. doi: 10.1200/JCO.2014.56.2736. Epub 2015 Feb 9.

ReferenceCitation: Robert C, Thomas L, Bondarenko I, O'Day S, Weber J, Garbe C, Lebbe C, Baurain JF, Testori A, Grob JJ, Davidson N, Richards J, Maio M, Hauschild A, Miller WH Jr, Gascon P, Lotem M, Harmankaya K, Ibrahim R, Francis S, Chen TT, Humphrey R, Hoos A, Wolchok JD. Ipilimumab plus dacarbazine for previously untreated metastatic melanoma. N Engl J Med. 2011 Jun 30;364(26):2517-26. doi: 10.1056/NEJMoa1104621. Epub 2011 Jun 5.

lead_sponsor: Bristol-Myers Squibb

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Belgium
South Africa
Poland
Portugal
Austria
Australia
Russian Federation
Argentina
Israel
Norway
Brazil
Canada
Switzerland
Hungary
Germany
Ireland
Czech Republic
France
Chile
Netherlands

location_facility: Mid-Illinois Hematology/Oncology Associates, Ltd.

location_facility: Orlando Health, Inc. M.D. Anderson Cancer Center Orlando

location_facility: Saint Francis Hospital And Medical Center

location_facility: The Angeles Clinic And Research Institute

location_facility: Joe Arrington Cancer Research And Treatment Center

location_facility: Hematology Oncology Associates Of The Treasure Coast

location_facility: Cancer Specialists Of North Florida Beaches


title: A Phase 2, Placebo-Controlled, Randomized, Double Blind, Parallel Arm, Dose Ranging Study to Evaluate Safety and Efficacy of Apixaban in Patients With a Recent Acute Coronary Syndrome.

summary: The purpose of this clinical research study is to determine whether apixaban will be safe in people who have recently had unstable angina or a heart attack.

primary_purpose: Prevention

ReferenceCitation: APPRAISE Steering Committee and Investigators, Alexander JH, Becker RC, Bhatt DL, Cools F, Crea F, Dellborg M, Fox KA, Goodman SG, Harrington RA, Huber K, Husted S, Lewis BS, Lopez-Sendon J, Mohan P, Montalescot G, Ruda M, Ruzyllo W, Verheugt F, Wallentin L. Apixaban, an oral, direct, selective factor Xa inhibitor, in combination with antiplatelet therapy after acute coronary syndrome: results of the Apixaban for Prevention of Acute Ischemic and Safety Events (APPRAISE) trial. Circulation. 2009 Jun 9;119(22):2877-85. doi: 10.1161/CIRCULATIONAHA.108.832139. Epub 2009 May 26.

location_country:
Denmark
Poland
Spain
Italy
Austria
Russian Federation
United Kingdom
Canada
Sweden
United States
France
Israel
Belgium
Germany

location_facility: Los Angeles County & University Of Southern Ca. Medical Cen.

location_facility: University Of Texas Medical School - San Antonio

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: Scottsdale Cardiovasular Research Institute


title: A Phase III, Randomized, Double-Blinded, Multi-Center, Study to Assess the Efficacy of Docetaxel (TAXOTERE™) in Combination With ZD6474 (ZACTIMA™) Versus Docetaxel (TAXOTERE™) With Placebo in Subjects With Locally Advanced or Metastatic NSCLC

acronym: ZODIAC

summary:
This large phase III clinical study is studying the effect of vandetanib (ZACTIMA) in treating non-small cell lung cancer (NSCLC). Vandetanib is a new type of agent that targets the blood supply to a cancer tumour (through it's anti-vascular endothelial growth factor receptor (VEGFR) properties) and the tumour cells themselves (through it's anti-endothelial growth factor receptor (EGFR) actions). This study will look at the effects of vandetanib in lung cancer patients who have had their cancer re-appear after treatment with standard chemotherapy.

This clinical study will test if the vandetanib anti-VEGF and anti-EGFR characteristics can deliver longer improved progression free survival and improved overall survival than docetaxel (Taxotere) alone.

All patients participating this clinical study will receive treatment with docetaxel, a commonly used treatment for recurrent non-small cell lung cancer.

In addition, some patients will also receive vandetanib (ZACTIMA), an anti-EGFR / anti-VEGF agent.

Recent clinical research shows that vascular endothelial growth factor receptor (VEGFR) inhibition, when used with standard chemotherapy, can lead to increased survival in advanced non-small cell lung cancer (NSCLC) patients.

Other research shows that epidermal growth factor receptor (EGFR) inhibitors, like erlotinib (Tarceva) can also increase overall non-small cell lung cancer survival by killing tumour cells and stopping them from dividing.

ReferenceCitation: Lombard A, Mistry H, Aarons L, Ogungbenro K. Dose individualisation in oncology using chemotherapy-induced neutropenia: Example of docetaxel in non-small cell lung cancer patients. Br J Clin Pharmacol. 2021 Apr;87(4):2053-2063. doi: 10.1111/bcp.14614. Epub 2020 Dec 19.

ReferenceCitation: Platt A, Morten J, Ji Q, Elvin P, Womack C, Su X, Donald E, Gray N, Read J, Bigley G, Blockley L, Cresswell C, Dale A, Davies A, Zhang T, Fan S, Fu H, Gladwin A, Harrod G, Stevens J, Williams V, Ye Q, Zheng L, de Boer R, Herbst RS, Lee JS, Vasselli J. A retrospective analysis of RET translocation, gene copy number gain and expression in NSCLC patients treated with vandetanib in four randomized Phase III studies. BMC Cancer. 2015 Mar 23;15:171. doi: 10.1186/s12885-015-1146-8.

ReferenceCitation: Heymach JV, Lockwood SJ, Herbst RS, Johnson BE, Ryan AJ. EGFR biomarkers predict benefit from vandetanib in combination with docetaxel in a randomized phase III study of second-line treatment of patients with advanced non-small cell lung cancer. Ann Oncol. 2014 Oct;25(10):1941-1948. doi: 10.1093/annonc/mdu269. Epub 2014 Jul 23.

ReferenceCitation: Herbst RS, Sun Y, Eberhardt WE, Germonpré P, Saijo N, Zhou C, Wang J, Li L, Kabbinavar F, Ichinose Y, Qin S, Zhang L, Biesma B, Heymach JV, Langmuir P, Kennedy SJ, Tada H, Johnson BE. Vandetanib plus docetaxel versus docetaxel as second-line treatment for patients with advanced non-small-cell lung cancer (ZODIAC): a double-blind, randomised, phase 3 trial. Lancet Oncol. 2010 Jul;11(7):619-26. doi: 10.1016/S1470-2045(10)70132-7.

lead_sponsor: Genzyme, a Sanofi Company

location_country:
Spain
Italy
United States
Belgium
Japan
Portugal
Austria
Argentina
Indonesia
India
Turkey
Mexico
Malaysia
Singapore
Brazil
Canada
China
Germany
Denmark
Greece
Thailand
Vietnam
Korea, Republic of
France
Netherlands


title: A Multicentre, Randomised, Open Clinical Study to Compare the Efficacy and Safety of a Combination Therapy of Tacrolimus With Sirolimus Versus Tacrolimus With Mycophenolate Mofetil in Kidney Transplantation.

acronym: RESTORE

summary: Primary objective of this study is to compare the two therapy regimens with regard to renal function by using calculated creatinine clearance. The secondary objectives are to compare the efficacy and safety profiles of the two therapy regimens.

lead_sponsor: Astellas Pharma Inc

location_country:
Poland
Romania
Spain
Italy
Austria
Australia
Netherlands
United Kingdom
Czech Republic
Sweden
Hungary
France
Belgium
Germany


title: Prospective, Open-Label, Comparative, Multi-Center Study Of Voriconazole Compared To Itraconazole For The Primary Prophylaxis Of Invasive Fungal Infection (IFI) With Allogeneic Hematopoietic Stem Cell Transplants (HSCT)

acronym: IMPROVIT

summary: Study is to compare antifungal prophylaxis of Voriconazole and Itraconazole in subjects who have had a Stem Cell Transplant. The success of the end point will be measured using evidence of Infection, drug compliance and survival.

lead_sponsor: Pfizer

location_country:
Portugal
Jordan
Spain
Greece
Russian Federation
United Kingdom
Canada
Czech Republic
Switzerland
France
Turkey
Egypt


title: Protocol CV185017: A Phase 2 Randomized, Parallel-Arm Study of Oral Direct Factor Xa-Inhibitor Apixaban and Low Molecular Weight Heparin or Fondaparinux With A Vitamin K Antagonist In Subjects With Acute Symptomatic Deep-Vein Thrombosis

summary: The purpose of this clinical research study is to assess efficacy and safety of 3 doses of apixaban 5 mg twice a day, 10 mg twice a day and 20 mg once daily versus conventional treatment with low molecular weight heparin or fondaparinux and vitamin K antagonist in the treatment of subjects with acute symptomatic deep-vein thrombosis.

location_country:
Poland
Italy
Austria
Australia
Czech Republic
Sweden
United States
France
Israel
South Africa
Netherlands


title: A Randomised, Double-blind, Parallel-group, Placebo Controlled Study of Esomeprazole i.v. (Bolus Infusion of 80 mg Followed by a Continuous Infusion of 8 mg Per Hour) Administered for 72 Hours to Assess Prevention of Rebleeding in Subjects That Have Undergone Successful Primary Endoscopic Haemostasis of a Bleeding Peptic Ulcer - the PUB Study.

summary: This study is being carried out to see if constant 3 days infusion of Nexium is effective in preventing rebleeding after an endoscopic treatment.

ReferenceCitation: Lau J, Lind T, Persson T, Eklund S. Effect of baseline characteristics on response to proton pump inhibitors in patients with peptic ulcer bleeding. J Dig Dis. 2017 Feb;18(2):99-106. doi: 10.1111/1751-2980.12447.

ReferenceCitation: Kuipers EJ, Sung JJ, Barkun A, Mössner J, Jensen D, Stuart R, Lau JY, Ahlbom H, Lind T, Kilhamn J. Safety and tolerability of high-dose intravenous esomeprazole for prevention of peptic ulcer rebleeding. Adv Ther. 2011 Feb;28(2):150-9. doi: 10.1007/s12325-010-0095-5. Epub 2010 Dec 15.

ReferenceCitation: Barkun AN, Adam V, Sung JJ, Kuipers EJ, Mössner J, Jensen D, Stuart R, Lau JY, Nauclér E, Kilhamn J, Granstedt H, Liljas B, Lind T. Cost effectiveness of high-dose intravenous esomeprazole for peptic ulcer bleeding. Pharmacoeconomics. 2010;28(3):217-30. doi: 10.2165/11531480-000000000-00000.

ReferenceCitation: Sung JJ, Barkun A, Kuipers EJ, Mössner J, Jensen DM, Stuart R, Lau JY, Ahlbom H, Kilhamn J, Lind T; Peptic Ulcer Bleed Study Group. Intravenous esomeprazole for prevention of recurrent peptic ulcer bleeding: a randomized trial. Ann Intern Med. 2009 Apr 7;150(7):455-64. Epub 2009 Feb 16.

location_country:
Denmark
Hong Kong
Spain
Greece
Austria
Netherlands
Russian Federation
Finland
United Kingdom
Sweden
France
South Africa
Turkey
Romania
Norway
Germany


title: A Double-blind, Randomized, Multicentre Trial Comparing the Efficacy and Tolerability of 250mg of Faslodex (Long Acting ICI 182,780) With 20mg of Nolvadex (Tamoxifen) in Postmenopausal Women With Advanced Breast Cancer

summary: The purpose of this study is to compare the efficacy of Faslodex (fulvestrant) to Nolvadex (tamoxifen) as first-line treatment for postmenopausal women with advanced breast cancer. Patients will be treated until disease progression or until the investigator has determined that treatment is not in the best interest of the patient, whichever occurs first.

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Japan
South Africa
Poland
Portugal
Russian Federation
Austria
Australia
Argentina
Israel
Turkey
Mexico
Brazil
Canada
Hungary
Germany
Taiwan
Ireland
New Zealand
Finland
France
Netherlands


title: A 104-Week, Open-label, Multi-centre, Phase IIIb Study Evaluating the Effect of Treatment With Rosuvastatin 40 mg on Atherosclerotic Disease as Measured by Intravascular Ultrasound and Quantitative Coronary Angiography in Subjects Undergoing Coronary Angiography Who Have Coronary Artery Disease

summary: The purpose of this study is to see if 40 mg of rosuvastatin taken daily will reduce the atherosclerosis (fatty deposits) in your arteries

design_allocation: Non-Randomized

ReferenceType: result

ReferenceCitation: Nissen SE, Nicholls SJ, Sipahi I, Libby P, Raichlen JS, Ballantyne CM, Davignon J, Erbel R, Fruchart JC, Tardif JC, Schoenhagen P, Crowe T, Cain V, Wolski K, Goormastic M, Tuzcu EM; ASTEROID Investigators. Effect of very high-intensity statin therapy on regression of coronary atherosclerosis: the ASTEROID trial. JAMA. 2006 Apr 5;295(13):1556-65. Epub 2006 Mar 13.

location_country:
Spain
Italy
Australia
Canada
United States
France
Belgium
Netherlands


type: Other Identifier

title: Fabry Disease Registry Protocol

summary:
The Fabry Registry is an ongoing, international multi-center, strictly observational program that tracks the routine clinical outcomes for patients with Fabry disease, irrespective of treatment status. No experimental intervention is involved; patients in the Registry undergo clinical assessments and receive care as determined by the patient's treating physician.

The primary objectives of the Registry are:

To enhance the understanding of the variability, progression, and natural history of Fabry disease, including heterozygous females with the disease;
To assist the Fabry medical community with the development of recommendations for monitoring patients and reports on patient outcomes to help optimize patient care;
To characterize and describe the Fabry population as a whole;
To evaluate the long-term safety and effectiveness of Fabrazyme®

Fabry Pregnancy Sub-registry: This Sub-registry is a multicenter, international, longitudinal, observational, and voluntary program designed to track pregnancy outcomes for any pregnant woman enrolled in the Fabry Registry, regardless of whether she is receiving disease-specific therapy (such as enzyme replacement therapy with agalsidase beta) and irrespective of the commercial product with which she may be treated. Data from the Sub-registry are also used to fulfill various global regulatory requirements, to support product development/reimbursement, and for other research and non-research-related purposes. No experimental intervention is given; thus a patient will undergo clinical assessments and receive standard of care treatment as determined by the patient's physician. If a patient consents to this Sub-registry, information about the patient's medical and obstetric history, pregnancy, and birth will be collected, and, if a patient consents to data collection for her infant, data on infant growth through month 36 postpartum will be collected.

status: Recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Other

enrollment_type: Anticipated

ReferenceType: background

ReferenceCitation: Germain DP, Brand E, Burlina A, Cecchi F, Garman SC, Kempf J, Laney DA, Linhart A, Maródi L, Nicholls K, Ortiz A, Pieruzzi F, Shankar SP, Waldek S, Wanner C, Jovanovic A. Phenotypic characteristics of the p.Asn215Ser (p.N215S) GLA mutation in male and female patients with Fabry disease: A multicenter Fabry Registry study. Mol Genet Genomic Med. 2018 Apr 12. doi: 10.1002/mgg3.389. [Epub ahead of print]

ReferenceCitation: Wilcox WR, Feldt-Rasmussen U, Martins AM, Ortiz A, Lemay RM, Jovanovic A, Germain DP, Varas C, Nicholls K, Weidemann F, Hopkin RJ. Improvement of Fabry Disease-Related Gastrointestinal Symptoms in a Significant Proportion of Female Patients Treated with Agalsidase Beta: Data from the Fabry Registry. JIMD Rep. 2018;38:45-51. doi: 10.1007/8904_2017_28. Epub 2017 May 17.

ReferenceCitation: Hopkin RJ, Cabrera G, Charrow J, Lemay R, Martins AM, Mauer M, Ortiz A, Patel MR, Sims K, Waldek S, Warnock DG, Wilcox WR. Risk factors for severe clinical events in male and female patients with Fabry disease treated with agalsidase beta enzyme replacement therapy: Data from the Fabry Registry. Mol Genet Metab. 2016 Sep;119(1-2):151-9. doi: 10.1016/j.ymgme.2016.06.007. Epub 2016 Jun 13.

ReferenceCitation: Wanner C, Feldt-Rasmussen U, Ortiz A. Plain language summary of a study looking at heart muscle thickness and kidney function in women with Fabry disease who received agalsidase beta treatment. Future Cardiol. 2022 Sep;18(10):755-763. doi: 10.2217/fca-2022-0047. Epub 2022 Sep 8.

ReferenceCitation: Ortiz A, Abiose A, Bichet DG, Cabrera G, Charrow J, Germain DP, Hopkin RJ, Jovanovic A, Linhart A, Maruti SS, Mauer M, Oliveira JP, Patel MR, Politei J, Waldek S, Wanner C, Yoo HW, Warnock DG. Time to treatment benefit for adult patients with Fabry disease receiving agalsidase β: data from the Fabry Registry. J Med Genet. 2016 Jul;53(7):495-502. doi: 10.1136/jmedgenet-2015-103486. Epub 2016 Mar 18.

ReferenceCitation: Germain DP, Charrow J, Desnick RJ, Guffon N, Kempf J, Lachmann RH, Lemay R, Linthorst GE, Packman S, Scott CR, Waldek S, Warnock DG, Weinreb NJ, Wilcox WR. Ten-year outcome of enzyme replacement therapy with agalsidase beta in patients with Fabry disease. J Med Genet. 2015 May;52(5):353-8. doi: 10.1136/jmedgenet-2014-102797. Epub 2015 Mar 20.

location_country:
Croatia
Serbia
Saudi Arabia
Italy
Spain
United Kingdom
Lithuania
United States
Peru
Belgium
Japan
Philippines
Romania
Czechia
Poland
Portugal
Slovenia
Russian Federation
Australia
Argentina
Indonesia
India
Norway
Malaysia
Singapore
Sweden
Slovakia
Kuwait
Brazil
Canada
Hungary
China
Germany
Bulgaria
Denmark
Taiwan
Estonia
Finland
Thailand
Vietnam
Korea, Republic of
France
Chile
Colombia
Netherlands
United Arab Emirates

location_facility: Metropolitan Hospital Center-Site Number:840110

location_facility: University of Rochester Medical Center SOM-Site Number:840105

location_facility: Arkansas Childrens Hospital-Site Number:840109

location_facility: University of Florida Pediatrics Genetics-Site Number:840121

location_facility: Baylor Research Center-Site Number:840058

location_facility: University of Virginia School of Medicine-Pediatrics-Site Number:840078

location_facility: UCLA School Of Medicine-Site Number:840088

location_facility: University of Missouri Health System Department of Genetics-Site Number:840031

location_facility: University of Utah Department of Medical Genetics-Site Number:840043

location_facility: Massachusetts General Hospital-Genetics-Site Number:840062

location_facility: University of Louisville- Genetics-Site Number:840030

location_facility: New York Medical College-Site Number:840039

location_facility: Children's Specialty Center of Nevada-Site Number:840008

location_facility: Indianapolis University School of Medicine-Site Number:840027

location_facility: Rush University Medical Center Genetics-Site Number:840079

location_facility: Atlantic Health System-Site Number:840099

location_facility: USC Health Sciences Center Dept of Genetics-Site Number:840082

location_facility: University of Alabama Birmingham- Nephrology-Site Number:840073

location_facility: State University of New York-Site Number:840052

location_facility: Boston Children's Hospital-Site Number:840092

location_facility: University of California at San Francisco-Site Number:840051

location_facility: LSD Data Registry Site LLC-Site Number:840094

location_facility: Children's Hospital and Clinics of Minnesota-Site Number:840046

location_facility: UC Davis MIND Institute-Site Number:840010

location_facility: Shodair Children's Hospital-Site Number:840090

location_facility: Phoenix Children's Hospital-Site Number:840003

location_facility: Loma Linda University Children's Hospital-Site Number:840117

location_facility: Stanford Unviersity MC Dept of Genetics-Site Number:840022

location_facility: University Of Miami SOM-Site Number:840006

location_facility: Southern California Permanente Medical Group-Site Number:840108

location_facility: St. Peter's University Hospital-Site Number:840016

location_facility: Ann and Robert Lurie Children's Hospital-Site Number:840013

location_facility: Cleveland Clinic Foundation Pediatrics-Site Number:840048

location_facility: Oregon Health & Science University-Site Number:840116

location_facility: Children's Hospital of Philadelphia-Site Number:840034

location_facility: Ohio State University Department of Genetics-Site Number:840097

location_facility: Washington University of St. Louis-Site Number:840100

location_facility: Vanderbilt University Hospital-Pediatrics-Site Number:840049

location_facility: Cincinnati Children's Hospital-Genetics-Site Number:840033

location_facility: University of Nebraska Medical Center- Pediatrics-Site Number:840084

location_facility: Children's National Medical Center-Site Number:840067

location_facility: St. Joseph's Children's Hospital-Site Number:840057

location_facility: University of Pittsburgh-Site Number:840023

location_facility: Brigham and Women's Hospital-Neurology-Site Number:840103

location_facility: University Of Washington Medical Center-Site Number:840059

location_facility: Kaiser Permanente Hospital-Site Number:840042

location_facility: Ochsner Medical Center-Site Number:840120

location_facility: Emory University School of Medicine- Human Genetics-Site Number:840060

location_facility: University of Michigan Pediatrics-Site Number:840107

location_facility: University of California at San Diego-Site Number:840007

location_facility: Tulane University Medical Center-Site Number:840001

location_facility: Children's Health Care-Site Number:840114

location_facility: Carolinas Medical Center-Site Number:840065

location_facility: Children's Hospital of Orange County-Site Number:840074

location_facility: University of California at Irvine-Site Number:840036

location_facility: Children's Hospital of Philadelphia HUP Medical Genetics-Site Number:840089

location_facility: Penn State University Medical Center-Neurology-Site Number:840104

location_facility: Children's Hospital of the Kings Daughters-Site Number:840072

location_facility: University of Alabama Birmingham- Nephrology-Site Number:840018

location_facility: Children's Hospital Oakland-Site Number:840029

location_facility: Nationwide Children's Hospital-Site Number:840091

location_facility: Rhode Island Hospital Genetics-Site Number:840053

location_facility: Icahn School of Medicine-Site Number:840080

location_facility: University of Colorado at Denver Genetics-Site Number:840068

location_facility: University of Minnesota Medical Center Pediatrics-Site Number:840076

location_facility: Maine Medical Center Pediatrics-Site Number:840064

location_facility: New York University School Of Medicine-Site Number:840040

location_facility: University Hematology Oncology-Site Number:840075

location_facility: University Of Kansas Medical Center-Site Number:840071

location_facility: Seattle Children's Hospital-Site Number:840028

location_facility: University of Arizona-Site Number:840015

location_facility: Multicare Health System � Mary Bridge Childrens Hospital-Site Number:840115

location_facility: Children's Hospital of Wisconsin-Pediatrics-Site Number:840054

location_facility: Oregon Health and Scinece University-Site Number:840038

location_facility: Cook Children's Health Care System-Site Number:840024

location_facility: Joseph M. Sanzari Children's Hospital-Site Number:840101

location_facility: University of Arkansas for Medical Sciences-Site Number:840113

location_facility: University of Florida Dept of Genetics-Site Number:840083

location_facility: Duke University Medical Center Genetics Dept-Site Number:840045

location_facility: University of Florida-Genetics-Site Number:840096

location_facility: Children's Hospital of Michigan-Site Number:840066

status_simplified: Ongoing


title: A Multicentre, Randomised, Double Blind, Two Arm Parallel Group Study to Evaluate and Compare the Efficacy and Safety of Modified Release Tacrolimus FK506E (MR4) Versus Tacrolimus FK506 in Combination With Steroids in Patients Undergoing Primary Liver Transplantation

summary: To evaluate and to compare efficacy and safety of a dual regimen with oral modified release tacrolimus FK506E (MR4) / steroids versus a dual regimen with oral tacrolimus FK506 / steroids in patients undergoing primary liver transplantation. It shall be demonstrated that FK506E (MR4) is non-inferior to FK506 with regards to the primary endpoint.

ReferenceCitation: Ericzon BG, Varo E, Trunečka P, Fischer L, Colledan M, Gridelli B, Valdivieso A, O'Grady J, Dickinson J, Undre N. Pharmacokinetics of prolonged-release tacrolimus versus immediate-release tacrolimus in de novo liver transplantation: A randomized phase III substudy. Clin Transplant. 2017 Jun;31(6). doi: 10.1111/ctr.12958. Epub 2017 Apr 27.

location_country:
Poland
Brazil
Spain
Ireland
Italy
Australia
United Kingdom
Canada
Czech Republic
Finland
Switzerland
Sweden
France
Belgium
Norway
Germany


title: The Use of Zoledronic Acid to Prevent Cancer-treatment Bone Loss in Post-menopausal Women Receiving Adjuvant Letrozole for Breast Cancer

summary: Post-menopausal breast cancer patients will receive letrozole 2.5 mg daily for the treatment of breast cancer and will be randomized to a treatment group to receive either upfront zoledronic acid 4 mg IV 15-minute infusion every 6 months or delayed start zoledronic acid 4 mg IV 15-minute infusion every 6 months. Delayed start zoledronic acid will be initiated when either the Bone Mineral Density T-score is below -2 Standard Deviations at either the lumbar spine or hip or any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the month 36 scheduled visit. Letrozole 2.5 mg will be given daily for 5 years.

lead_sponsor: Novartis Pharmaceuticals

location_country:
Saudi Arabia
Italy
Spain
Argentina
Korea, Republic of
France
South Africa
Belgium
Netherlands


title: A Phase 3, Randomized, Double-blind, Placebo Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of BMS-298585 in Combination With Metformin Therapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone

summary: A Phase 3, Randomized, Double-blind, Placebo Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of BMS-298585 in Combination with Metformin Therapy in Subjects with Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone

location_country:
Brazil
United Kingdom
Australia
Argentina
Canada
Korea, Republic of
United States
France
Peru
Puerto Rico
Mexico
Sweden


title: A 1-Year Open-Label Safety Extension Study of Pregabalin in Patients With Anxiety Disorders

summary: Determine long-term safety and tolerability of pregabalin in patients with anxiety disorders.

ReferenceCitation: Montgomery S, Emir B, Haswell H, Prieto R. Long-term treatment of anxiety disorders with pregabalin: a 1 year open-label study of safety and tolerability. Curr Med Res Opin. 2013 Oct;29(10):1223-30. doi: 10.1185/03007995.2013.820694. Epub 2013 Aug 19.

location_country:
Poland
Spain
Italy
Austria
Estonia
Latvia
Netherlands
United Kingdom
Ukraine
France
Israel
South Africa
Belgium
Germany


title: A Double-Blind, Randomized, Placebo- Controlled Study Of Atorvastatin As Prevention Of Cerebrovascular Events In Patients With A Previous Transient Ischemic Attack (TIA) Or Stroke

acronym: SPARCL

summary: To determine whether Lipitor reduces stroke, compared to placebo in patients who have had a previous stroke or transient ischemic attack.

ReferenceCitation: Amarenco P, Bogousslavsky J, Callahan A 3rd, Goldstein LB, Hennerici M, Rudolph AE, Sillesen H, Simunovic L, Szarek M, Welch KM, Zivin JA; Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) Investigators. High-dose atorvastatin after stroke or transient ischemic attack. N Engl J Med. 2006 Aug 10;355(6):549-59. Erratum in: N Engl J Med. 2018 Jun 13;:null.

ReferenceCitation: Szarek M, Amarenco P, Callahan A, DeMicco D, Fayyad R, Goldstein LB, Laskey R, Sillesen H, Welch KM; SPARCL Committees and Investigators. Atorvastatin Reduces First and Subsequent Vascular Events Across Vascular Territories: The SPARCL Trial. J Am Coll Cardiol. 2020 May 5;75(17):2110-2118. doi: 10.1016/j.jacc.2020.03.015. Epub 2020 Mar 16.

ReferenceCitation: Vogt L, Bangalore S, Fayyad R, Melamed S, Hovingh GK, DeMicco DA, Waters DD. Atorvastatin Has a Dose-Dependent Beneficial Effect on Kidney Function and Associated Cardiovascular Outcomes: Post Hoc Analysis of 6 Double-Blind Randomized Controlled Trials. J Am Heart Assoc. 2019 May 7;8(9):e010827. doi: 10.1161/JAHA.118.010827.

ReferenceCitation: Ganz P, Amarenco P, Goldstein LB, Sillesen H, Bao W, Preston GM, Welch KMA; SPARCL Steering Committee. Association of Osteopontin, Neopterin, and Myeloperoxidase With Stroke Risk in Patients With Prior Stroke or Transient Ischemic Attacks: Results of an Analysis of 13 Biomarkers From the Stroke Prevention by Aggressive Reduction in Cholesterol Levels Trial. Stroke. 2017 Dec;48(12):3223-3231. doi: 10.1161/STROKEAHA.117.017965. Epub 2017 Nov 7.

ReferenceCitation: Byun YS, Yang X, Bao W, DeMicco D, Laskey R, Witztum JL, Tsimikas S; SPARCL Trial Investigators. Oxidized Phospholipids on Apolipoprotein B-100 and Recurrent Ischemic Events Following Stroke or Transient Ischemic Attack. J Am Coll Cardiol. 2017 Jan 17;69(2):147-158. doi: 10.1016/j.jacc.2016.10.057.

ReferenceCitation: Amarenco P, Callahan A 3rd, Campese VM, Goldstein LB, Hennerici MG, Messig M, Sillesen H, Welch KM, Wilson DJ, Zivin JA. Effect of high-dose atorvastatin on renal function in subjects with stroke or transient ischemic attack in the SPARCL trial. Stroke. 2014 Oct;45(10):2974-82. doi: 10.1161/STROKEAHA.114.005832. Epub 2014 Aug 21.

ReferenceCitation: Ovbiagele B, Goldstein LB, Amarenco P, Messig M, Sillesen H, Callahan A 3rd, Hennerici MG, Zivin J, Welch KM; SPARCL Investigators. Prediction of major vascular events after stroke: the stroke prevention by aggressive reduction in cholesterol levels trial. J Stroke Cerebrovasc Dis. 2014 Apr;23(4):778-84. doi: 10.1016/j.jstrokecerebrovasdis.2013.12.001. Epub 2014 Feb 24.

ReferenceCitation: Callahan A, Amarenco P, Goldstein LB, Sillesen H, Messig M, Samsa GP, Altafullah I, Ledbetter LY, MacLeod MJ, Scott R, Hennerici M, Zivin JA, Welch KM; SPARCL Investigators. Risk of stroke and cardiovascular events after ischemic stroke or transient ischemic attack in patients with type 2 diabetes or metabolic syndrome: secondary analysis of the Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) trial. Arch Neurol. 2011 Oct;68(10):1245-51. doi: 10.1001/archneurol.2011.146. Epub 2011 Jun 13.

ReferenceCitation: Schwartz GG, Chaitman BR, Goldberger JJ, Messig M. High-dose atorvastatin and risk of atrial fibrillation in patients with prior stroke or transient ischemic attack: analysis of the Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) trial. Am Heart J. 2011 May;161(5):993-9. doi: 10.1016/j.ahj.2011.02.002.

ReferenceCitation: Amarenco P, Goldstein LB, Sillesen H, Benavente O, Zweifler RM, Callahan A 3rd, Hennerici MG, Zivin JA, Welch KM; Stroke Prevention by Aggressive Reduction in Cholesterol Levels Investigators. Coronary heart disease risk in patients with stroke or transient ischemic attack and no known coronary heart disease: findings from the Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) trial. Stroke. 2010 Mar;41(3):426-30. doi: 10.1161/STROKEAHA.109.564781. Epub 2010 Jan 28.

ReferenceCitation: Amarenco P, Goldstein LB, Callahan A 3rd, Sillesen H, Hennerici MG, O'Neill BJ, Rudolph AE, Simunovic L, Zivin JA, Welch KM; SPARCL Investigators. Baseline blood pressure, low- and high-density lipoproteins, and triglycerides and the risk of vascular events in the Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) trial. Atherosclerosis. 2009 Jun;204(2):515-20. doi: 10.1016/j.atherosclerosis.2008.09.008. Epub 2008 Sep 18.

location_country:
Spain
Italy
United Kingdom
Venezuela
South Africa
Belgium
Poland
Portugal
Austria
Australia
Israel
Mexico
Sweden
Slovakia
Brazil
Switzerland
Germany
Denmark
Greece
New Zealand
Finland
Czech Republic
France
Chile
Netherlands


title: A Phase III, Randomized, Controlled, Open-Label, Multicentre, Three Arm Study to Compare the Efficacy and Safety of a Dual-Boosted HIV-1 Protease Inhibitor Regimen of Fosamprenavir/Lopinavir/Ritonavir 1400mg/533mg/133mg Twice Daily and an Increased Dosage Regimen of FPV/RTV 1400mg/100mg BID Versus the Standard Dosage Regimen of FPV/RTV 700mg/100mg BID for 24 Weeks in Multiple-PI Experienced, HIV-Infected Adults Experiencing Virological Failure

summary: For HIV-infected individuals with highly resistant viruses, higher drug levels may be required to block the virus. This study investigates that concept by comparing the efficacy of standard fosamprenavir/ritonavir to an increased dose of boosted fosamprenavir and to a combination of fosamprenavir (increased dose)/lopinavir/ritonavir.

lead_sponsor: GlaxoSmithKline

location_country:
Spain
Greece
Italy
Australia
United Kingdom
Canada
France
Belgium
Germany

location_facility:
GSK Clinical Trials call Center
GSK Clinical Trials Call Centre
GSK Clinical Trials Call Center


title: An Open-Label, Multicenter Study With Follow-Up Evaluating the Safety and Efficacy of Varenicline Tartrate in Comparison to Transdermal Nicotine Patch for Smoking Cessation

summary: Open-label comparison of standard 12-week regimen of varenicline with standard 10-week regimen of transdermal nicotine patch for smoking cessation.

ReferenceCitation: Aubin HJ, Bobak A, Britton JR, Oncken C, Billing CB Jr, Gong J, Williams KE, Reeves KR. Varenicline versus transdermal nicotine patch for smoking cessation: results from a randomised open-label trial. Thorax. 2008 Aug;63(8):717-24. doi: 10.1136/thx.2007.090647. Epub 2008 Feb 8.

location_country:
United Kingdom
United States
France
Belgium
Netherlands


title: A Randomized, Open-label Study of the Effect of Replacing CNI With Sirolimus in a Standard Care Regimen of CNI, CellCept, and Steroids on Renal Function in Heart Transplant Patients

summary: Heart transplant patients on a standard care regimen of CNI, MMF, and corticosteroids will enter the study 4-6 weeks post-transplant. At 3 months after transplant, patients will be randomized to either continue this regimen or CNI therapy will be discontinued and replaced by sirolimus therapy (in combination with MMF and corticosteroids). The effect of these 2 regimens on efficacy, safety and renal function will be evaluated.The anticipated time on study treatment is 1-2 years and the target sample size is 500+ individuals.

location_country:
Spain
Austria
Australia
United States
France
Germany


title: A Randomized, Double-Blind, Controlled Evaluation of Tenofovir DF Versus Adefovir Dipivoxil for the Treatment of Presumed Pre-Core Mutant Chronic Hepatitis B

summary: This primary objectives of this study are to compare the efficacy, safety, and tolerability of tenofovir disoproxil fumarate (TDF) versus adefovir dipivoxil (ADV) for the treatment of pre-core mutant chronic hepatitis B. Participants will receive TDF or ADV for 48 weeks (double-blind). After 48 weeks, eligible participants switched to open-label TDF for up to 480 weeks.

ReferenceCitation: Kitrinos KM, Corsa A, Liu Y, Flaherty J, Snow-Lampart A, Marcellin P, Borroto-Esoda K, Miller MD. No detectable resistance to tenofovir disoproxil fumarate after 6 years of therapy in patients with chronic hepatitis B. Hepatology. 2014 Feb;59(2):434-42.

ReferenceCitation: Marcellin P, Gane E, Buti M, Afdhal N, Sievert W, Jacobson IM, Washington MK, Germanidis G, Flaherty JF, Aguilar Schall R, Bornstein JD, Kitrinos KM, Subramanian GM, McHutchison JG, Heathcote EJ. Regression of cirrhosis during treatment with tenofovir disoproxil fumarate for chronic hepatitis B: a 5-year open-label follow-up study. Lancet. 2013 Feb 9;381(9865):468-75. doi: 10.1016/S0140-6736(12)61425-1. Epub 2012 Dec 10.

ReferenceCitation: Gordon SC, Krastev Z, Horban A, Petersen J, Sperl J, Dinh P, Martins EB, Yee LJ, Flaherty JF, Kitrinos KM, Rustgi VK, Marcellin P. Efficacy of tenofovir disoproxil fumarate at 240 weeks in patients with chronic hepatitis B with high baseline viral load. Hepatology. 2013 Aug;58(2):505-13. doi: 10.1002/hep.26277. Epub 2013 May 3.

ReferenceCitation: Tsai NC, Marcellin P, Buti M, Washington MK, Lee SS, Chan S, Trinh H, Flaherty JF, Kitrinos KM, Dinh P, Charuworn P, Subramanian GM, Gane E. Viral suppression and cirrhosis regression with tenofovir disoproxil fumarate in Asians with chronic hepatitis B. Dig Dis Sci. 2015 Jan;60(1):260-8. doi: 10.1007/s10620-014-3336-7. Epub 2014 Sep 2.

ReferenceCitation: Fung S, Gordon SC, Krastev Z, Horban A, Petersen J, Sperl J, Gane E, Jacobson IM, Yee LJ, Dinh P, Martins EB, Flaherty JF, Kitrinos KM, Dusheiko G, Trinh H, Flisiak R, Rustgi VK, Buti M, Marcellin P. Tenofovir disoproxil fumarate in Asian or Pacific Islander chronic hepatitis B patients with high viral load (≥ 9 log10 copies/ml). Liver Int. 2015 Feb;35(2):422-8. doi: 10.1111/liv.12694. Epub 2014 Oct 28.

ReferenceCitation: Buti M, Fung S, Gane E, Afdhal NH, Flisiak R, Gurel S, Flaherty JF, Martins EB, Yee LJ, Dinh P, Bornstein JD, Mani Subramanian G, Janssen HL, George J, Marcellin P. Long-term clinical outcomes in cirrhotic chronic hepatitis B patients treated with tenofovir disoproxil fumarate for up to 5 years. Hepatol Int. 2015 Apr;9(2):243-50. doi: 10.1007/s12072-015-9614-4. Epub 2015 Mar 13.

ReferenceCitation: Buti M, Tsai N, Petersen J, Flisiak R, Gurel S, Krastev Z, Aguilar Schall R, Flaherty JF, Martins EB, Charuworn P, Kitrinos KM, Subramanian GM, Gane E, Marcellin P. Seven-year efficacy and safety of treatment with tenofovir disoproxil fumarate for chronic hepatitis B virus infection. Dig Dis Sci. 2015 May;60(5):1457-64. doi: 10.1007/s10620-014-3486-7. Epub 2014 Dec 23.

ReferenceCitation: Corsa A, Liu Y, Flaherty JF, Marcellin P, Miller M, Kitrinos KM. No Detectable Resistance to Tenofovir Disoproxil Fumarate (TDF) in HBeAg+ and HBeAg- Patients With Chronic Hepatitis B (CHB) After Eight Years of Treatment [Abstract 1707]. The 65th Annual Meeting of the American Association for the Study of Liver Diseases: The Liver Meeting (AASLD); 2014 08-10 November; Boston MA.

ReferenceCitation: Marcellin P, Gane EJ, Flisiak R, Trinh HN, Petersen J, Gurel S, et al. Long Term Treatment with Tenofovir Disoproxil Fumarate for Chronic Hepatitis B Infection is Safe and Well Tolerated and Associated with Durable Virologic Response with no Detectable Resistance: 8 Year Results from Two Phase 3 Trials [Abstract]. 55th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD); 2014 November 7-11; Boston, MA.

ReferenceCitation: Gane EJ, Marcellin P, Sievert W, Trinh HN, Shiffman ML, Washington MK, et al. Five years of Treatment with Tenofovir DF for Chronic Hepatitis B Infection in Asian Patients is Associated with Sustained Viral Suppression and Significant Regression of Histological Fibrosis and Cirrhosis [Poster Number 1429]. 62nd Annual Meeting of the American Association for the Study of Liver Diseases; 2011 November 4-8; San Francisco, California.

ReferenceCitation: Liu Y, Corsa AC, Buti M, Cathcart AL, Flaherty JF, Miller MD, Kitrinos KM, Marcellin P, Gane EJ. No detectable resistance to tenofovir disoproxil fumarate in HBeAg+ and HBeAg- patients with chronic hepatitis B after 8 years of treatment. J Viral Hepat. 2017 Jan;24(1):68-74. doi: 10.1111/jvh.12613. Epub 2016 Sep 23.

ReferenceCitation: Marcellin P, Wong DK, Sievert W, Buggisch P, Petersen J, Flisiak R, Manns M, Kaita K, Krastev Z, Lee SS, Cathcart AL, Crans G, Op den Brouw M, Jump B, Gaggar A, Flaherty J, Buti M. Ten-year efficacy and safety of tenofovir disoproxil fumarate treatment for chronic hepatitis B virus infection. Liver Int. 2019 Oct;39(10):1868-1875. doi: 10.1111/liv.14155. Epub 2019 Jul 10.

ReferenceCitation: Buti M, Wong DK, Gane E, Flisiak R, Manns M, Kaita K, Janssen HLA, Op den Brouw M, Jump B, Kitrinos K, Crans G, Flaherty J, Gaggar A, Marcellin P. Safety and efficacy of stopping tenofovir disoproxil fumarate in patients with chronic hepatitis B following at least 8 years of therapy: a prespecified follow-up analysis of two randomised trials. Lancet Gastroenterol Hepatol. 2019 Apr;4(4):296-304. doi: 10.1016/S2468-1253(19)30015-9. Epub 2019 Feb 20.

ReferenceCitation: Jacobson IM, Washington MK, Buti M, Thompson A, Afdhal N, Flisiak R, Akarca US, Tchernev KG, Flaherty JF, Aguilar Schall R, Myers RP, Subramanian GM, McHutchison JG, Younossi Z, Marcellin P, Patel K. Factors Associated With Persistent Increase in Level of Alanine Aminotransferase in Patients With Chronic Hepatitis B Receiving Oral Antiviral Therapy. Clin Gastroenterol Hepatol. 2017 Jul;15(7):1087-1094.e2. doi: 10.1016/j.cgh.2017.01.032. Epub 2017 Feb 12.

ReferenceCitation: Pan CQ, Chan S, Trinh H, Yao A, Bae H, Lou L. Similar efficacy and safety of tenofovir in Asians and non-Asians with chronic hepatitis B. World J Gastroenterol. 2015 May 14;21(18):5524-31. doi: 10.3748/wjg.v21.i18.5524.

ReferenceCitation: Heathcote EJ, Marcellin P, Buti M, Gane E, De Man RA, Krastev Z, Germanidis G, Lee SS, Flisiak R, Kaita K, Manns M, Kotzev I, Tchernev K, Buggisch P, Weilert F, Kurdas OO, Shiffman ML, Trinh H, Gurel S, Snow-Lampart A, Borroto-Esoda K, Mondou E, Anderson J, Sorbel J, Rousseau F. Three-year efficacy and safety of tenofovir disoproxil fumarate treatment for chronic hepatitis B. Gastroenterology. 2011 Jan;140(1):132-43. doi: 10.1053/j.gastro.2010.10.011. Epub 2010 Oct 16.

ReferenceCitation: Marcellin P, Heathcote EJ, Buti M, Gane E, de Man RA, Krastev Z, Germanidis G, Lee SS, Flisiak R, Kaita K, Manns M, Kotzev I, Tchernev K, Buggisch P, Weilert F, Kurdas OO, Shiffman ML, Trinh H, Washington MK, Sorbel J, Anderson J, Snow-Lampart A, Mondou E, Quinn J, Rousseau F. Tenofovir disoproxil fumarate versus adefovir dipivoxil for chronic hepatitis B. N Engl J Med. 2008 Dec 4;359(23):2442-55. doi: 10.1056/NEJMoa0802878.

lead_sponsor: Gilead Sciences

location_country:
Poland
Spain
Greece
Italy
Australia
Netherlands
Canada
Czech Republic
New Zealand
United Kingdom
United States
France
Turkey
Germany
Bulgaria


title: A Randomised, Open-label, Multi-centre Phase II Study of BAY43-9006 (Sorafenib) Versus Standard Treatment With Interferon Alpha-2a in Patients With Unresectable and/or Metastatic Renal Cell Carcinoma.

summary:
The purpose of the study is to:

Find out if patients receiving BAY43-9006 will live longer without tumor progression than those receiving standard therapy with interferon alpha-2a
Find out if a higher dose of BAY43-9006 can inhibit tumor progression in patients who progressed during standard dose treatment with BAY43-9006, and for how long these patients live without progression
Find out how long patients live without progression who receive BAY43-9006 after failing to respond to standard therapy with interferon alpha-2a
Find out in how many percent of patients BAY43-9006 prevents the growth of or shrinks kidney tumors and/or their metastases depending on treatment and dosage
Find out if BAY43-9006 has any effect on the quality of life of patients with kidney cancer
Find out the level of BAY43-9006 in the blood once per month and any changes in this level
Find out whether BAY43-9006 effects are associated with specific biomarkers

ReferenceCitation: Escudier B, Szczylik C, Hutson TE, Demkow T, Staehler M, Rolland F, Negrier S, Laferriere N, Scheuring UJ, Cella D, Shah S, Bukowski RM. Randomized phase II trial of first-line treatment with sorafenib versus interferon Alfa-2a in patients with metastatic renal cell carcinoma. J Clin Oncol. 2009 Mar 10;27(8):1280-9. doi: 10.1200/JCO.2008.19.3342. Epub 2009 Jan 26. Erratum in: J Clin Oncol. 2009 May 1; 27(13):2305.

lead_sponsor: Bayer

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


title: Phase III Randomized, Placebo Controlled Study of Sorafenib in Repeated Cycles of 21 Days in Combination With Paclitaxel/Carboplatin Chemotherapy in Subjects With Unresectable Stage III or Stage IV Melanoma.

summary: The objectives of this study are to compare the anti-tumor activity as measured by Progression Free Survival (PFS) and tolerability of Sorafenib in combination with Paclitaxel and Carboplatin versus Paclitaxel and Carboplatin in combination with placebo in subjects with unresectable Stage III or Stage IV melanoma who progressed after receiving only one prior therapy containing Dacarbazine (DTIC) or Temozolomide (TMZ).

ReferenceCitation: Hauschild A, Agarwala SS, Trefzer U, Hogg D, Robert C, Hersey P, Eggermont A, Grabbe S, Gonzalez R, Gille J, Peschel C, Schadendorf D, Garbe C, O'Day S, Daud A, White JM, Xia C, Patel K, Kirkwood JM, Keilholz U. Results of a phase III, randomized, placebo-controlled study of sorafenib in combination with carboplatin and paclitaxel as second-line treatment in patients with unresectable stage III or stage IV melanoma. J Clin Oncol. 2009 Jun 10;27(17):2823-30. doi: 10.1200/JCO.2007.15.7636. Epub 2009 Apr 6.

location_country:
United Kingdom
Australia
Netherlands
Canada
United States
France
Germany


title: An Eight-week, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study to Evaluate Efficacy and Safety of Talnetant in Subjects With Irritable Bowel Syndrome

summary: This study will evaluate the effectiveness and safety of the investigational drug talnetant in treating subjects with irritable bowel syndrome (IBS).

location_country:
Spain
United Kingdom
Australia
Netherlands
Canada
Sweden
United States
France
South Africa
Germany


title: Multicenter, Randomized, Double-Blind, Active Controlled Trial Comparing REMICADE� (Infliximab) and REMICADE Plus Azathioprine to Azathioprine in the Treatment of Patients With Crohn's Disease Naive to Both Immunomodulators and Biologic Therapy

summary: The purpose of this study is to assess the safety and effectiveness of three different treatments for patients with Crohns disease who have not responded to previous treatment with a group of drugs commonly used to treat Crohn's Disease (5-ASA) and corticosteroids. Patients will receive either infliximab (a drug used to treat autoimmune diseases) or azathioprine (an immunosuppressant or drug used to suppress the immune system) or a combination of both for up to 34 weeks. This research study will involve approximately 500 patients. The main study involves up to 34 weeks (approximately 8 months). A study extension of an additional 20 weeks (approximately 5 months) is optional for patients who successfully complete the main study. A country-specific study extension of open label infliximab treatment for an additional 1 year is optional for patients who successfully complete the main study extension.

ReferenceCitation: Colombel JF, Sandborn WJ, Reinisch W, Mantzaris GJ, Kornbluth A, Rachmilewitz D, Lichtiger S, D'Haens G, Diamond RH, Broussard DL, Tang KL, van der Woude CJ, Rutgeerts P; SONIC Study Group. Infliximab, azathioprine, or combination therapy for Crohn's disease. N Engl J Med. 2010 Apr 15;362(15):1383-95. doi: 10.1056/NEJMoa0904492.

ReferenceCitation: Dulai PS, Wong ECL, Reinisch W, Narula N. Clinical Decision Support Tool for Infliximab in Crohn's Disease. Clin Gastroenterol Hepatol. 2022 May;20(5):e1192-e1195. doi: 10.1016/j.cgh.2021.06.037. Epub 2021 Jun 30.

ReferenceCitation: Colombel JF, Adedokun OJ, Gasink C, Gao LL, Cornillie FJ, D'Haens GR, Rutgeerts PJ, Reinisch W, Sandborn WJ, Hanauer SB. Combination Therapy With Infliximab and Azathioprine Improves Infliximab Pharmacokinetic Features and Efficacy: A Post Hoc Analysis. Clin Gastroenterol Hepatol. 2019 Jul;17(8):1525-1532.e1. doi: 10.1016/j.cgh.2018.09.033. Epub 2018 Sep 26.

ReferenceCitation: Colombel JF, Reinisch W, Mantzaris GJ, Kornbluth A, Rutgeerts P, Tang KL, Oortwijn A, Bevelander GS, Cornillie FJ, Sandborn WJ. Randomised clinical trial: deep remission in biologic and immunomodulator naïve patients with Crohn's disease - a SONIC post hoc analysis. Aliment Pharmacol Ther. 2015 Apr;41(8):734-46. doi: 10.1111/apt.13139. Epub 2015 Mar 1.

ReferenceCitation: Reinisch W, Colombel JF, Sandborn WJ, Mantzaris GJ, Kornbluth A, Adedokun OJ, Miller M, Tang KL, Rutgeerts P, Cornillie F. Factors associated with short- and long-term outcomes of therapy for Crohn's disease. Clin Gastroenterol Hepatol. 2015 Mar;13(3):539-547.e2. doi: 10.1016/j.cgh.2014.09.031. Epub 2014 Sep 19.

ReferenceCitation: Peyrin-Biroulet L, Reinisch W, Colombel JF, Mantzaris GJ, Kornbluth A, Diamond R, Rutgeerts P, Tang LK, Cornillie FJ, Sandborn WJ. Clinical disease activity, C-reactive protein normalisation and mucosal healing in Crohn's disease in the SONIC trial. Gut. 2014 Jan;63(1):88-95. doi: 10.1136/gutjnl-2013-304984. Epub 2013 Aug 23.

ReferenceCitation: Ferrante M, Colombel JF, Sandborn WJ, Reinisch W, Mantzaris GJ, Kornbluth A, Rachmilewitz D, Lichtiger S, D'Haens GR, van der Woude CJ, Danese S, Diamond RH, Oortwijn AF, Tang KL, Miller M, Cornillie F, Rutgeerts PJ; International Organization for the Study of Inflammatory Bowel Diseases. Validation of endoscopic activity scores in patients with Crohn's disease based on a post hoc analysis of data from SONIC. Gastroenterology. 2013 Nov;145(5):978-986.e5. doi: 10.1053/j.gastro.2013.08.010. Epub 2013 Aug 14.

lead_sponsor: Centocor Ortho Biotech Services, L.L.C.

location_country:
Denmark
Portugal
Spain
Greece
Austria
Netherlands
United Kingdom
Canada
Sweden
United States
France
Israel
Belgium
Norway
Germany

intervention_type: Biological


title: A Phase III Randomized, Open-Label Study of CG1940 and CG8711 Versus Docetaxel and Prednisone in Patients With Metastatic Hormone-Refractory Prostate Cancer Who Are Chemotherapy-Naïve

summary: The purpose of this study is to compare the duration of survival between GVAX® immunotherapy for prostate cancer and chemotherapy treatment in patients with prostate cancer who no longer respond to hormone therapy, who have documented metastases, and who have not been treated with chemotherapy in the past.

ReferenceCitation: Vuky J, Corman JM, Porter C, Olgac S, Auerbach E, Dahl K. Phase II trial of neoadjuvant docetaxel and CG1940/CG8711 followed by radical prostatectomy in patients with high-risk clinically localized prostate cancer. Oncologist. 2013 Jun;18(6):687-8. doi: 10.1634/theoncologist.2011-0234. Epub 2013 Jun 5.

lead_sponsor: Cell Genesys

location_country:
United Kingdom
Netherlands
Canada
Sweden
United States
France
Belgium
Germany

location_facility: Centre Hopitalier Universitaire de Sherbrooke

location_facility: Fort Wayne Medical Oncology/Hematology Inc.

location_facility: Compassionate Cancer Care Medical Group, Inc.

location_facility: The Center for Cancer & Hematologic Disease

location_facility: Michael and Dianne Bienes Comprehensive Cancer Center, Holy Cross Hospital

location_facility: Centre Leon Berard Service de Cancerologie Medicale

location_facility: Hematology/Oncology Centers of the Northern Rockies, P.C.

location_facility: Peachtree Hematology Oncology Consultants, PC

location_facility: Urology Specialists and Associates, P.A.

location_facility: Hematology Oncology Associates of the Treasure Coast

location_facility: William Beaumont Hospital, Cancer Clinical Trials Office

location_facility: Medcenter One Cancer Care / Odyssey Research

location_facility: The Don and Sybil Harrington Cancer Center

location_facility: Frederick Memorial Hospital Regional Cancer Therapy Center

location_facility: Winship Cancer Institute, Emory University

location_facility: Presbyterian Hospital/ Center for Cancer Research

location_facility: Summit Medical Group/Overlook Oncology Center

location_facility: Center for Oncology Research and Treatment PA

location_facility: Cleveland Clinic Foundation, Taussig Cancer Center

location_facility: Oxford Cancer Centre, Churchill Hospital

location_facility: Oncology-Hematology Group of South Florida/Advanced Medical Specialists

location_facility: West Michigan Regional Cancer and Blood Center

location_facility: Hematology-Oncology Associates of Northern New Jersey

location_facility: Northwestern Carolina Hematology Oncology, PA

location_facility: Southwestern Oncology Research Department


title: A Randomized Phase 3 Trial of ALIMTA and Cisplatin Versus GEMZAR and Cisplatin in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

summary: This study is a randomized Phase 3 study comparing pemetrexed and cisplatin combination to gemcitabine and cisplatin for the treatment of Non Small Cell Lung Cancer (NCSLC). Gemcitabine plus cisplatin is currently the standard of care for NSCLC. It is thought that pemetrexed plus cisplatin may be as effective and may have fewer side effects than the standard of care.

ReferenceCitation: Wu YL, Lu S, Cheng Y, Zhou C, Wang M, Qin S, Lu Y, Zhang Y, Zhu Y, Song X, Wang X, Barraclough H, Zhang X, Chi H, Orlando M. Efficacy and safety of pemetrexed/cisplatin versus gemcitabine/cisplatin as first-line treatment in Chinese patients with advanced nonsquamous non-small cell lung cancer. Lung Cancer. 2014 Sep;85(3):401-7. doi: 10.1016/j.lungcan.2014.07.007. Epub 2014 Jul 17.

ReferenceCitation: Gridelli C, Brodowicz T, Langer CJ, Peterson P, Islam M, Guba SC, Moore P, Visseren-Grul CM, Scagliotti G. Pemetrexed therapy in elderly patients with good performance status: analysis of two phase III trials of patients with nonsquamous non-small-cell lung cancer. Clin Lung Cancer. 2012 Sep;13(5):340-6. doi: 10.1016/j.cllc.2011.12.002. Epub 2012 Jan 23.

ipd_sharing: Yes

ipd_sharing_description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Poland
Portugal
Austria
Australia
Argentina
Puerto Rico
India
Israel
Turkey
Mexico
Sweden
Brazil
Canada
Hungary
Germany
Denmark
Taiwan
Greece
Finland
Korea, Republic of
France
Netherlands

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician


title: A Randomized, Open-Label, Phase III Study of RPR109881 IV Every 3 Weeks Versus Capecitabine (Xeloda) Tablets Twice Daily for 2 Weeks in 3-Week Cycles in Patients With Metastatic Breast Cancer Progressing After Taxanes and Anthracycline Therapy

summary: The purpose of this clinical trial is to determine if RPR109881 is a better treatment than capecitabine (Xeloda) for advanced breast cancer in patients that no longer benefit from docetaxel and/or paclitaxel.

lead_sponsor: Sanofi

location_country:
Spain
Italy
United Kingdom
United States
Romania
South Africa
Poland
Portugal
Slovenia
Austria
Australia
Argentina
Israel
Mexico
Brazil
Canada
Hungary
Germany
Taiwan
New Zealand
Finland
Czech Republic
Korea, Republic of
France
Chile
Colombia


title: An Open Label Trial of TMC114/RTV in HIV-1 Infected, Treatment-experienced Subjects.

summary: The primary objective of the TMC114-C215 study is to evaluate the safety and tolerability of TMC114/RTV over time. The secondary objectives are to evaluate the antiviral activity over time and to evaluate the immunological effect over time.

ReferenceCitation: Molina JM, Cohen C, Katlama C, Grinsztejn B, Timerman A, Pedro Rde J, Vangeneugden T, Miralles D, Meyer SD, Parys W, Lefebvre E; TMC114-C208 Study Group; TMC114-C215 Study Group. Safety and efficacy of darunavir (TMC114) with low-dose ritonavir in treatment-experienced patients: 24-week results of POWER 3. J Acquir Immune Defic Syndr. 2007 Sep 1;46(1):24-31.

lead_sponsor: Tibotec Pharmaceuticals, Ireland

location_country:
Brazil
Portugal
Spain
United Kingdom
Austria
Australia
Argentina
Canada
Hungary
United States
France
Belgium
Germany


title: An Open-Label Randomized Phase III Study of Intermittent Oral Capecitabine in Combination With Intravenous Oxaliplatin (Q3W) ("XELOX") Versus Bolus and Continuous Infusion Fluorouracil/ Intravenous Leucovorin With Intravenous Oxaliplatin (Q2W) ("FOLFOX4") as Treatment for Patients With Metastatic Colorectal Cancer Who Have Received Prior Treatment With CPT-11 in Combination With 5-FU/LV as First Line Therapy

summary: This 2 arm study will assess the efficacy and safety of intermittent oral Xeloda, or iv fluorouracil/leucovorin, in combination with intravenous Eloxatin (oxaliplatin) in patients previously treated for metastatic colorectal cancer. Patients will be randomized to receive either 1)XELOX (Xeloda 1000mg/m2 po bid on days 1-15 + oxaliplatin) in 3 week cycles or 2) FOLFOX-4 (oxaliplatin + leucovorin + 5-FU in 2 week cycles. The anticipated time on study treatment is until disease progression, and the target sample size is 500+ individuals.

location_country:
Croatia
Poland
Taiwan
Serbia
Slovenia
Greece
Italy
Spain
United Kingdom
Finland
Canada
Korea, Republic of
United States
France
Israel
Puerto Rico
Belgium
South Africa
Germany
Slovakia


title: A Muticenter, Randomized, Double-blind, Placebo Controlled Trial Comparing the Efficacy and Safety of Reteplease and Abciximab Combination Therapy With Abciximab Alone Administered Early or Just Prior to Primary Primary Percutaneous Coronary Intervention for Acute Myocardial Infarction.

summary: The purpose of this study is to determine whether abciximab given in combination with reteplase, before patients have a coronary intervention (a standard treatment where a catheter is inserted into the heart artery to get blood flowing past the clot), is safe and effective in the treatment of heart attacks compared to only abciximab given during coronary intervention.

ReferenceCitation: Ellis SG, Armstrong P, Betriu A, Brodie B, Herrmann H, Montalescot G, Neumann FJ, Smith JJ, Topol E; Facilitated Intervention with Enhanced Reperfusion Speed to Stop Events Investigators. Facilitated percutaneous coronary intervention versus primary percutaneous coronary intervention: design and rationale of the Facilitated Intervention with Enhanced Reperfusion Speed to Stop Events (FINESSE) trial. Am Heart J. 2004 Apr;147(4):E16.

ReferenceCitation: Ellis SG, Tendera M, de Belder MA, van Boven AJ, Widimsky P, Janssens L, Andersen HR, Betriu A, Savonitto S, Adamus J, Peruga JZ, Kosmider M, Katz O, Neunteufl T, Jorgova J, Dorobantu M, Grinfeld L, Armstrong P, Brodie BR, Herrmann HC, Montalescot G, Neumann FJ, Effron MB, Barnathan ES, Topol EJ; FINESSE Investigators. Facilitated PCI in patients with ST-elevation myocardial infarction. N Engl J Med. 2008 May 22;358(21):2205-17. doi: 10.1056/NEJMoa0706816.

ReferenceCitation: Montalescot G, Ellis SG, de Belder MA, Janssens L, Katz O, Pluta W, Ecollan P, Tendera M, van Boven AJ, Widimsky P, Andersen HR, Betriu A, Armstrong P, Brodie BR, Herrmann HC, Neumann FJ, Effron MB, Lu J, Barnathan ES, Topol EJ; Facilitated INtervention with Enhanced Reperfusion Speed to Stop Events Investigators. Enoxaparin in primary and facilitated percutaneous coronary intervention A formal prospective nonrandomized substudy of the FINESSE trial (Facilitated INtervention with Enhanced Reperfusion Speed to Stop Events). JACC Cardiovasc Interv. 2010 Feb;3(2):203-12. doi: 10.1016/j.jcin.2009.11.012.

ReferenceCitation: Herrmann HC, Lu J, Brodie BR, Armstrong PW, Montalescot G, Betriu A, Neuman FJ, Effron MB, Barnathan ES, Topol EJ, Ellis SG; FINESSE Investigators. Benefit of facilitated percutaneous coronary intervention in high-risk ST-segment elevation myocardial infarction patients presenting to nonpercutaneous coronary intervention hospitals. JACC Cardiovasc Interv. 2009 Oct;2(10):917-24. doi: 10.1016/j.jcin.2009.06.018.

ReferenceCitation: Ellis SG, Tendera M, de Belder MA, van Boven AJ, Widimsky P, Andersen HR, Betriu A, Savonitto S, Adamus J, Peruga JZ, Hamankiewicz M, Pluta W, Oldroyd K, Ecollan P, Janssens L, Armstrong P, Brodie BR, Herrmann HC, Montalescot G, Neumann FJ, Effron MB, Barnathan ES, Topol EJ; FINESSE Investigators. 1-year survival in a randomized trial of facilitated reperfusion: results from the FINESSE (Facilitated Intervention with Enhanced Reperfusion Speed to Stop Events) trial. JACC Cardiovasc Interv. 2009 Oct;2(10):909-16. doi: 10.1016/j.jcin.2009.07.009.

lead_sponsor: Centocor, Inc.

location_country:
Denmark
Poland
Romania
Spain
United Kingdom
Austria
Netherlands
Argentina
Canada
Czech Republic
Switzerland
Sweden
United States
France
Israel
South Africa
Belgium
Germany
Bulgaria


title: A Phase 3 Trial of ALIMTA (LY231514, Pemetrexed) Plus GEMZAR Versus GEMZAR in Patients With Unresectable or Metastatic Cancer of the Pancreas.

summary: Definition: This study will compare the drug GEMZAR to a combination of GEMZAR plus ALIMTA for the treatment of cancer of the pancreas. Patients may be able to participate in this study if they have cancer in their pancreas that cannot be removed by surgery OR that has spread to a new site in their body.

lead_sponsor: Eli Lilly and Company

location_country:
Taiwan
Portugal
Spain
Colombia
Austria
Australia
Greece
Argentina
Italy
Netherlands
United Kingdom
Sweden
Venezuela
United States
France
Peru
Belgium
Germany


title: A Phase 3 Trial of LY900003 Plus Gemcitabine and Cisplatin Versus Gemcitabine and Cisplatin in Patients With Advanced, Previously Untreated Non-Small Cell Lung Cancer

summary:
The purposes of this study are to determine:

If treatment with LY900003 plus gemcitabine and cisplatin can help you live longer, compared with gemcitabine and cisplatin alone.
The safety of LY900003 plus gemcitabine and cisplatin and any side effects that might be associated with the combination of these three drugs.
Whether LY900003 plus gemcitabine and cisplatin can make your tumor smaller or disappear, and for how long, compared with gemcitabine and cisplatin alone.

It is possible that information collected during this study will be analyzed by the sponsor in the future to evaluate LY900003 plus gemcitabine and cisplatin for other possible uses or for other medical or scientific purposes other than those currently proposed.

LY900003 may not add any benefit to gemcitabine plus cisplatin.

location_country:
Spain
Italy
United Kingdom
United States
Romania
Belgium
South Africa
Poland
Russian Federation
Argentina
Puerto Rico
India
Norway
Sweden
Switzerland
Hungary
Germany
Taiwan
France
Chile
Netherlands


title: Multi-Center, Randomized Open-Label Study to Evaluate the Safety and Efficacy of Immunotherapy With Subcutaneous Maxamine (Histamine Dihydrochloride) Plus Proleukin (Interleukin-2) Versus No Treatment (Standard of Care) in Patients With Acute Myeloid Leukemia in First or Subsequent Complete Remission (CR)

summary:
RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill acute myeloid leukemia cells. Histamine dihydrochloride may prolong remission and reduce the risk of relapse in patients with acute myeloid leukemia in remission.

PURPOSE: Randomized phase III trial to determine the effectiveness of interleukin-2 plus histamine dihydrochloride in treating patients who have acute myeloid leukemia that is in remission following previous therapy.

ReferenceCitation: Buyse M, Michiels S, Squifflet P, Lucchesi KJ, Hellstrand K, Brune ML, Castaigne S, Rowe JM. Leukemia-free survival as a surrogate end point for overall survival in the evaluation of maintenance therapy for patients with acute myeloid leukemia in complete remission. Haematologica. 2011 Aug;96(8):1106-12. doi: 10.3324/haematol.2010.039131. Epub 2011 May 5.

ReferenceCitation: Buyse M, Squifflet P, Lucchesi KJ, Brune ML, Castaigne S, Rowe JM. Assessment of the consistency and robustness of results from a multicenter trial of remission maintenance therapy for acute myeloid leukemia. Trials. 2011 Mar 23;12:86. doi: 10.1186/1745-6215-12-86.

lead_sponsor: Maxim Pharmaceuticals

location_country:
Denmark
United Kingdom
Estonia
Australia
Canada
Finland
New Zealand
Sweden
United States
France
Israel
Germany

location_facility: Washington University School of Medicine

location_facility: Birmingham Heartlands and Solihull NHS Trust (Teaching)

location_facility: Centre Hospitalier Regional et Universitaire d'Angers

location_facility: Bethesda Bone Marrow Stem Cell Transplant Institute

location_facility: Tel-Aviv Medical Center-Ichilov Hospital

location_facility: Maine Center for Cancer Medicine and Blood Disorders

location_facility: University of Oklahoma Health Sciences Center

location_facility: University of Alabama Comprehensive Cancer Center

location_facility: Universitaetsklinik und Strahlenklinik - Essen

location_facility: New York Presbyterian Hospital - Cornell Campus

location_facility: University of Florida Health Science Center - Jacksonville

location_facility: Centre Hospitalier Universitaire de Quebec, Pavillion de Quebec

location_facility: Kaiser Permanente-Southern California Permanente Medical Group

location_facility: Ottawa Regional Cancer Center - General Division

location_facility: Queen Elizabeth II Health Science Center

location_facility: University of Pennsylvania Cancer Center

location_facility: University of New Mexico Cancer Research & Treatment Center

location_facility: University of Auckland School of Medicine


title: RANDOMIZED PHASE II STUDY IN FIRST LINE HORMONAL TREATMENT FOR METASTATIC BREAST CANCER WITH EXEMESTANE OR TAMOXIFEN IN POSTMENOPAUSAL PATIENTS

summary:
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using exemestane or tamoxifen may fight cancer by blocking the uptake of estrogen.

PURPOSE: Randomized phase II/III trial to compare the effectiveness of exemestane with that of tamoxifen in treating postmenopausal women who have locally recurrent or metastatic breast cancer.

ReferenceCitation: Paridaens RJ, Dirix LY, Beex LV, Nooij M, Cameron DA, Cufer T, Piccart MJ, Bogaerts J, Therasse P. Phase III study comparing exemestane with tamoxifen as first-line hormonal treatment of metastatic breast cancer in postmenopausal women: the European Organisation for Research and Treatment of Cancer Breast Cancer Cooperative Group. J Clin Oncol. 2008 Oct 20;26(30):4883-90. doi: 10.1200/JCO.2007.14.4659. Epub 2008 Sep 15.

ReferenceCitation: Atalay G, Dirix L, Biganzoli L, Beex L, Nooij M, Cameron D, Lohrisch C, Cufer T, Lobelle JP, Mattiaci MR, Piccart M, Paridaens R. The effect of exemestane on serum lipid profile in postmenopausal women with metastatic breast cancer: a companion study to EORTC Trial 10951, 'Randomized phase II study in first line hormonal treatment for metastatic breast cancer with exemestane or tamoxifen in postmenopausal patients'. Ann Oncol. 2004 Feb;15(2):211-7.

ReferenceCitation: Paridaens R, Therasse P, Dirix L, et al.: First line hormonal treatment (HT) for metastatic breast cancer (MBC) with exemestane (E) or tamoxifen (T) in postmenopausal patients (pts): A randomized phase III trial of the EORTC Breast group. [Abstract] J Clin Oncol 22 (Suppl 14): A-515, 6s, 2004.

ReferenceCitation: Paridaens R, Therasse P, Dirix L, et al.: First results of a randomized phase III trial comparing exemestane versus tamoxifen as first-line hormone therapy (HT) for postmenopausal women with metastatic breast cancer (MBC) : EORTC 10951 in collaboration with the exemestane working group and NCIC Clinical Trials Group. [Abstract] Eur J Cancer 2 (Suppl 3): A-241, 126, 2004.

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

location_country:
Poland
Taiwan
Slovenia
United Kingdom
Russian Federation
Australia
Netherlands
Thailand
France
Belgium
Philippines
Malaysia

location_facility: Medisch Centrum Haaglanden Locatle Antoniushove

location_facility: Centre de Lutte Contre le Cancer, Georges-Francois Leclerc

location_facility: Centre Hospitalier Universitaire de Tivoli

location_facility: Russian Academy of Medical Sciences Cancer Research Center


title: A Multicenter, Randomized, Double-Blind, Phase II Study to Evaluate the Safety, Tolerance and Efficacy of Multiple Doses of SCH 56592 Versus Fluconazole in the Treatment of Oropharyngeal Candidiasis (OPC) in HIV-Positive Patients

summary: The purpose of this study is to compare the safety and effectiveness of SCH 56592 with that of fluconazole in the treatment of OPC (a fungal infection of the throat) in HIV-positive patients.

lead_sponsor: Schering-Plough

location_country:
Spain
Dominican Republic
Mexico
Argentina
Canada
Honduras
Thailand
Ethiopia
Guatemala
Venezuela
United States
Chile
France
Israel
Belgium
Panama
Germany
South Africa

location_facility: Program on AIDS / Thai Red Cross Society

location_facility: Hosp Roosevelt Chief Infectious Diseases Unit

location_facility: Hopital Guy de Chauliac Service des Maladies Infectieuses

location_facility: Rheinische Friedrich Wilhelms Universitaet Medizinische

location_facility: Service des Maladies Infectieuses Hopital de l Archet

location_facility: Hosp de Especialidades Centro Medico La Raza

location_facility: Rush Med College / Rush Presbyterian - St Luke's Med Cen

location_facility: Faculty of Medicine / Dept of Internal Medicine

location_facility: Universitat Munchen / Medizinische Poliklinik

location_facility: Thomas Jefferson Univ / Division of Infectious Disease

location_facility: Centro de Micologia / Facultad de Medicina UBA

location_facility: Univ of Stellenbosch Med School Depart Med Phys

location_facility: Avenida Lope de Vega Avenue esq/Calle Jose Amado Soler

location_facility: Universitaets Krankenhaus Eppendorf Medizinische Kernklinik


type: Registry Identifier

title: A Phase 3, Randomized, Open-label, Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination Versus Intravenous Nivolumab + Relatlimab Fixed-dose Combination in Participants With Previously Untreated Metastatic or Unresectable Melanoma

summary: The purpose of this study is to demonstrate that the study drug exposure level of the nivolumab + relatlimab FDC subcutaneous (SC) formulation is not worse than nivolumab + relatlimab FDC intravenous (IV) administration in participants with previously untreated metastatic or unresectable melanoma.

study_start_date_type: Anticipated

status: Not yet recruiting

ipd_sharing_description: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html

lead_sponsor: Bristol-Myers Squibb

location_country:
Poland
Brazil
Spain
Italy
Austria
Australia
Mexico
Argentina
Canada
United Kingdom
Sweden
United States
Chile
France
Belgium
Germany

location_facility: Dignity Health - St. Josephs Hospital and Medical Center

location_facility: Ft. Wayne Medical Oncology and Hematology

location_facility: Stanford Univ Med School Dept of Dermatology

location_facility: Greenebaum Cancer Center University of Maryland

location_facility: Intermountain Medical Center Campus Location


title: A Multicohort, Open Label, Phase 2 Study of Botensilimab (AGEN1181) for Treatment of Advanced Melanoma Refractory to Prior Checkpoint Inhibitor Therapy

summary: This study is an open-label, Phase 2, multicenter study to evaluate the efficacy, safety, tolerability, and pharmacokinetic profiles of botensilimab as monotherapy in participants with advanced melanoma refractory to checkpoint inhibitor therapy.

lead_sponsor: Agenus Inc.

location_country:
Brazil
Spain
Italy
United Kingdom
Switzerland
France
United States
Belgium
Germany

location_facility: IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori - IRST S.r.l.

location_facility: INCA II - Instituto Nacional de Cancer Jose Alencar Gomes da Silva

location_facility: Universitaetsmedizin der Johannes Gutenberg - Universitaet Mainz

location_facility: Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa

location_facility: Centro de Pesquisas Clinicas da Fundação Doutor Amaral Carvalho

location_facility: Istituto Nazionale Tumori IRCCS Fondazione G. Pascale

location_facility: Yale University School of Medicine - Yale Cancer Center

location_facility: Virginia K. Crosson Cancer Center at St. Jude Medical Center

location_facility: CHUV - Centre hospitalier universitaire vaudois

location_facility: Real e Benemerita Associaçao Portuguesa de Beneficencia - A Beneficencia Portuguesa de Sao Paulo

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Scottsdale Healthcare Hospitals DBA HonorHealth

location_facility: Consorcio Hospital General Universitario de Valencia

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: Azienda Ospedaliero Universitaria Senese

location_facility: Oncosite - Centro de Pesquisa Clinica Em Oncologia


title: A Phase I/Ib Study of JNJ-75276617 in Combination With Conventional Chemotherapy for Pediatric and Young Adult Participants With Relapsed/Refractory Acute Leukemias Harboring KMT2A, NPM1, or Nucleoporin Gene Alterations

summary: The purpose of this study is to determine the recommended Phase 2 dose(s) (RP2Ds) of JNJ-75276617 in combination with a conventional chemotherapy backbone in pediatric and young adult participants with relapsed/refractory acute leukemia harboring histone-lysine N-methyltransferase 2A1 ([KMT2A1], nucleophosmin 1 gene (NPM1), or nucleoporin alterations in Part 1 (Dose Escalation) and to further evaluate safety at the RP2D(s) of JNJ-75276617 in combination with chemotherapy in pediatric and young adult participants with relapsed/refractory acute leukemia harboring KMT2A1, NPM1, or nucleoporin alterations and safety at the RP2D(s) of JNJ-75276617 as monotherapy in a select low burden of disease cohort in Part 2 (Dose Expansion).

ipd_sharing_description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

lead_sponsor: Janssen Research & Development, LLC

location_country:
United Kingdom
Spain
United States
France
Germany

location_facility: Dr. Von Haunersches Kinderspital der Universitaet Muenchen

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum

location_facility: Institut D'Hematologie Et D'Oncologie Pediatrique

location_facility: Children's Wisconsin - Milwaukee Hospital

location_facility: Centre Hospitalier Universitaire de Nancy - Hôpital Central


title: SPI-62 as a Treatment for Hypercortisolism Related to a Benign Adrenal Tumor

acronym: ACSPIRE

summary: This will be a randomized, double-blind study to evaluate the efficacy, safety, and pharmacological effect of SPI-62 in subjects with hypercortisolism related to a benign adrenal tumor.

lead_sponsor: Sparrow Pharmaceuticals

location_country:
United Kingdom
Italy
United States
France
Romania
Germany
Bulgaria

location_facility: Unit of Endocrinology and Diabetes Prevention and Care - University of Bologna

location_facility: IU Simon Cancer Center - Indiana University

location_facility: Diabetes and Endocrinology Associates of Stark County, Inc

location_facility: Universitatea de Medicina si Farmacie Targu Mures - Spitalul Clinic Judetean de Urgenta Targu Mures

location_facility: Azienda Ospedaliera Universitaria "Federico II"

location_facility: University of California Los Angeles (UCLA) Medicine, Division of Endocrinology

location_facility: Spitalul Clinic Judeţean de Urgenţe "Sf. Spiridon"

location_facility: Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Cochin - Centre de Reference Maladies Rares

location_facility: Medizinische Klinik IV, Klinikum der Universität München

location_facility: Presidio Ospedaliero universitario "Santa Maria della Misericordia" di Udine

location_facility: National Institute of Endocrinology Aviatorilor, National Institute of Endocrinology Bucuresti

location_facility: USHATE "Acad. Ivan Penchev", Medical University-Sofia

location_facility: Fondazione Policlinico Universitario Agostino Gemelli

location_facility: Eastern Virginia Medical School - Strelitz Diabetes Center

location_facility: University Multiprofile Hospital for Active Treatment "Alexandrovska"

location_facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

location_facility: Sant'Andrea Hospital Sapienza University of Rome

location_facility: Mayo Clinic Cancer Center (MCCC) - Rochester

location_facility: Endocrinology and Metabolism, AOU Policlinico Paolo Giaccone, University of Palermo, Italy

location_facility: Endocrinology Ospedali Riuniti Ancona UNIVPM

location_facility: Azienda Ospedaliero - Universitaria San Luigi Gonzaga