Brief Title
Rucaparib in Patients With Locally Advanced or Metastatic Urothelial Carcinoma
Official Title
A Phase 2, Open-label Study of Rucaparib in Patients With Locally Advanced or Metastatic Urothelial Carcinoma
Brief Summary
The purpose of the ATLAS study is to determine how patients with locally advanced unresectable or metastatic urothelial carcinoma respond to treatment with rucaparib.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Objective Response Rate (ORR) Per RECIST Version 1.1
Secondary Outcome
Progression-free Survival (PFS) According to RECIST v1.1, as Assessed by the Investigator
Condition
Bladder Cancer
Intervention
Rucaparib
Study Arms / Comparison Groups
Rucaparib
Description: Oral rucaparib (monotherapy)
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
97
Start Date
June 1, 2018
Completion Date
January 15, 2020
Primary Completion Date
December 12, 2019
Eligibility Criteria
Inclusion Criteria: - Have histologically or cytologically confirmed locally advanced unresectable or metastatic transitional cell carcinoma of the urothelium (renal pelvis, ureter, urinary bladder or urethra) - 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: - Prior treatment with a PARP inhibitor - Symptomatic and/or untreated CNS metastases - Duodenal stent and/or any gastrointestinal disorder that may interfere with absorption of rucaparib
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
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Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT03397394
Organization ID
CO-338-085
Responsible Party
Sponsor
Study Sponsor
Clovis Oncology, Inc.
Collaborators
Foundation Medicine
Study Sponsor
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Verification Date
October 2020