Rucaparib in Patients With Locally Advanced or Metastatic Urothelial Carcinoma
A Phase 2, Open-label Study of Rucaparib in Patients With Locally Advanced or Metastatic Urothelial Carcinoma
The purpose of the ATLAS study is to determine how patients with locally advanced unresectable or metastatic urothelial carcinoma respond to treatment with rucaparib.
Objective Response Rate (ORR) Per RECIST Version 1.1
Progression-free Survival (PFS) According to RECIST v1.1, as Assessed by the Investigator
Study Arms / Comparison Groups
Description: Oral rucaparib (monotherapy)
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
June 1, 2018
January 15, 2020
Primary Completion Date
December 12, 2019
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
18 Years - N/A
Accepts Healthy Volunteers
Clovis Oncology, Inc.