Spots Global Cancer Trial Database for A Clinical Study of Cobimetinib Administered in Combination With Niraparib, With or Without Atezolizumab to Patients With Advanced Platinum-sensitive Ovarian Cancer
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Trial Identification
Brief Title: A Clinical Study of Cobimetinib Administered in Combination With Niraparib, With or Without Atezolizumab to Patients With Advanced Platinum-sensitive Ovarian Cancer
Official Title: A Phase Ib Study of Cobimetinib Administered in Combination With Niraparib, With or Without Atezolizumab, To Patients With Advanced Platinum-sensitive Ovarian Cancer
Study ID: NCT03695380
Conditions
Study Description
Brief Summary: The study will include a safety run-in phase (Stage 1) and a randomization phase (Stage 2). The purpose of Stage 1 is to evaluate the safety of cobimetinib when administered in combination with niraparib (Cohort 1) and cobimetinib with niraparib plus atezolizumab (Cohort 2). Stage 1 will enable patient enrollment in the randomized phase of the study (Stage 2) with both regimens at the recommended dose levels from Stage 1. Stage 2 is a randomized, dose-expansion phase, evaluating clinical outcomes in patients with advanced platinum-sensitive ovarian cancer. All patients will continue to receive study treatment until disease progression (according to "Response Evaluation Criteria in Solid Tumors" (RECIST), Version 1.1, unacceptable toxicity, death, or patient or investigator decision to withdraw, whichever occurs first.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
University of Arizona Cancer Center, North, Tucson, Arizona, United States
Moores Cancer Center at UC San Diego Health, La Jolla, California, United States
Mayo Clinic-Jacksonville, Jacksonville, Florida, United States
Florida Hospital Cancer Institute; Clinical Research Department, Orlando, Florida, United States
Medical College of Georgia; Obstetrics & Gynecolog, Augusta, Georgia, United States
Washington University School of Medicine; Dept of Medicine/Div of Medical Oncology, Saint Louis, Missouri, United States
Stephenson Cancer Center Investigational Pharmacy, Oklahoma City, Oklahoma, United States
Tennessee Oncology; Sarah Cannon Research Institute, Nashville, Tennessee, United States
Medical College of Wisconsin; Department of Obstetrics and Gynecology, Milwaukee, Wisconsin, United States
Istituto Nazionale Tumori Fondazione G. Pascale, Napoli, Campania, Italy
Fondazione Policlinico Universitario "A. Gemelli"; Unità di Fase 1: Unità di Farmacologia Clinica, Rome, Lazio, Italy
Istituto Europeo di Oncologia; Svil. Nuovi Farmaci per Terapie Innovative, Milano, Lombardia, Italy
Centro Oncologico de Galicia COG; Medical Oncology, A Coruna, LA Coruña, Spain
Hospital Universitari Vall dHebron; Oncology, Barcelona, , Spain
ICO Girona, Girona, , Spain
Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia, Jaen, , Spain
Clinica Universidad de Navarra Madrid; Servicio de Oncología, Madrid, , Spain
Hospital Ramon y Cajal; Servicio de Oncologia, Madrid, , Spain
Hospital Clinico San Carlos; Servicio de Oncologia, Madrid, , Spain
Hospital Clínico Universitario de Valencia; Servicio de Oncología, Valencia, , Spain
Contact Details
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