Rucaparib in Patients With Locally Advanced or Metastatic Urothelial Carcinoma
NCT ID: NCT03397394
Last Updated: 2023-06-09
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE2
97 participants
INTERVENTIONAL
2018-06-01
2020-01-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
RRx-001 Sequentially With a Platinum Doublet or a Platinum Doublet in Third-Line or Beyond in Patients With Small Cell Lung Cancer
NCT03699956
Rucaparib in Treating Patients With Genomic LOH High and/or Deleterious BRCA1/2 Mutation Stage IV or Recurrent Non-small Cell Lung Cancer (A Lung-MAP Treatment Trial)
NCT03845296
A Study to Evaluate the Efficacy and Safety of Rivoceranib in Participants With Recurrent or Metastatic Adenoid Cystic Carcinoma (ACC)
NCT04119453
Efficacy and Safety of the Combination of Rucaparib (PARP Inhibitor) and Atezolizumab (Anti-PD-L1 Antibody) in Patients With DNA Repair-deficient or Platinum-sensitive Solid Tumors
NCT04276376
Phase II Trial of Lurbinectedin Combined With Avelumab as Switch Maintenance Firstline Therapy
NCT05574504
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Rucaparib
Oral rucaparib (monotherapy)
Rucaparib
Rucaparib will be administered daily.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Rucaparib
Rucaparib will be administered daily.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Received 1 or 2 prior treatment regimens for advanced or metastatic disease
* Confirmed radiologic disease progression during or following recent treatment
* Mandatory biopsy is required during screening
* Measurable disease per RECIST v1.1
* Adequate organ function
* ECOG 0 or 1
Exclusion Criteria
* Symptomatic and/or untreated CNS metastases
* Duodenal stent and/or any gastrointestinal disorder that may interfere with absorption of rucaparib
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Foundation Medicine
INDUSTRY
pharmaand GmbH
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hospital del Mar
Barcelona, , Spain
Hospital Santa Creu i Sant Pau
Barcelona, , Spain
Pinnacle Oncology, Honor Health
Scottsdale, Arizona, United States
University of California San Diego (UCSD), Moores Cancer Center
La Jolla, California, United States
University of California, Los Angeles (UCLA)
Los Angeles, California, United States
Universityof California, Irvine
Orange, California, United States
Saint John's Health Center - John Wayne Cancer Institute (JWCI)
Santa Monica, California, United States
Stanford University School of Medicine
Stanford, California, United States
Hartford Health Care Cancer Institute
Hartford, Connecticut, United States
Eastern Connecticut Hematology & Oncology Associates (ECHO)
Norwich, Connecticut, United States
Medstar Georgetown University Medical Center
Washington D.C., District of Columbia, United States
Miami Cancer Institute, Baptist Health South Florida
Miami, Florida, United States
Northwestern University, Chicago
Chicago, Illinois, United States
Indiana University - Melvin and Bren Simon Cancer Center (IUSCC)
Indianapolis, Indiana, United States
The University of Iowa and Holden Comprehensive Cancer Center
Iowa City, Iowa, United States
Norton Cancer Center
Louisville, Kentucky, United States
Ochsner Cancer Institute
New Orleans, Louisiana, United States
University of Maryland, Marlene and Stewart Greenebaum Cancer Center
Baltimore, Maryland, United States
University of Michigan
Ann Arbor, Michigan, United States
Minnesota Oncology Hematology P.A. (USO - US Oncology)
Minneapolis, Minnesota, United States
Comprehensive Cancer Centers of Nevada (CCCN)
Las Vegas, Nevada, United States
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States
University of New Mexico UNM Cancer Research and Treatment Center
Albuquerque, New Mexico, United States
New York Oncology Hematology, P.C. (USO - US Oncology)
Albany, New York, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
New York - Presbyterian Hospital-Weill Cornell Medical Center
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Duke University, Duke Cancer Institute
Durham, North Carolina, United States
Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
Northwest Cancer Specialists P.C. (USO - US Oncology)
Portland, Oregon, United States
Providence Portland Medical Center
Portland, Oregon, United States
Oregon Health and Science University
Portland, Oregon, United States
Lehigh Valley Health Network
Allentown, Pennsylvania, United States
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States
Atlantic Urology Clinics
Myrtle Beach, South Carolina, United States
University Oncology & Hematology
Chattanooga, Tennessee, United States
Urology Associates
Nashville, Tennessee, United States
Texas Oncology PA (USO - US Oncology)
Dallas, Texas, United States
University of Texas, UT Health Science Center
Houston, Texas, United States
University of Utah, Huntsman Cancer Institute
Salt Lake City, Utah, United States
University of Virginia, Emily Couric Clinical Center
Charlottesville, Virginia, United States
University of Washington / Seattle Cancer Care Alliance
Seattle, Washington, United States
Froedtert & Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Centre de Lutte Contre le Cancer (CLCC) - Universite de Lyon - Centre Leon-Berard
Lyon, , France
Hopital Saint-Louis
Paris, , France
Centre de Lutte Contre le Cancer - Institut de Cancerologie de l'Ouest - Rene Gauducheau
Saint-Herblain, , France
Institut Universitaire du Cancer de Toulouse - Oncopole
Toulouse, , France
Institut Gustave Roussy
Villejuif, , France
Urologische und Kinderurologische Universitätsklinik im Malteser
Erlangen, , Germany
Universitatsklinikum Munster / Urologie und Kinderurologie
Münster, , Germany
Studienpraxis Urologie
Nürtingen, , Germany
Fondazionerca sul Cancro ONLUS - Istituto di Candiolo IRCCS
Candiolo, , Italy
IRCCS Ospedale San Raffaele - Medical Oncology Dept
Milan, , Italy
Fondazione IRCCS Istituto Nazionale Tumori
Milan, , Italy
Azienda Ospedaliera Universitaria Federico II Oncologia Medica
Naples, , Italy
Universidad de Navarra - Clinica Universitaria de Navarra
Pamplona, Navarre, Spain
Hospital Universitari Vall d'Hebron de Barcelona
Barcelona, , Spain
Hospital General Universitario Gregorio Maranon
Madrid, , Spain
Clinica Universitaria de Navarra Madrid
Madrid, , Spain
MD Anderson Cancer Center
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Clínico Universitario de Santiago de Compostela
Santiago de Compostela, , Spain
Sarah Cannon Research Institute - United Kingdom - London Office
London, , United Kingdom
Guy's & St. Thomas' Hospital (London Oncology Clinic)
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Grivas P, Loriot Y, Morales-Barrera R, Teo MY, Zakharia Y, Feyerabend S, Vogelzang NJ, Grande E, Adra N, Alva A, Necchi A, Rodriguez-Vida A, Gupta S, Josephs DH, Srinivas S, Wride K, Thomas D, Simmons A, Loehr A, Dusek RL, Nepert D, Chowdhury S. Efficacy and safety of rucaparib in previously treated, locally advanced or metastatic urothelial carcinoma from a phase 2, open-label trial (ATLAS). BMC Cancer. 2021 May 24;21(1):593. doi: 10.1186/s12885-021-08085-z.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2017-004166-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CO-338-085
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.