Status:
TERMINATED
Rucaparib in Patients With Locally Advanced or Metastatic Urothelial Carcinoma
Lead Sponsor:
pharmaand GmbH
Collaborating Sponsors:
Foundation Medicine
Conditions:
Bladder Cancer
Urothelial Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 15 2020
Estimated Enrollment :
97 Patients enrolled
Trial Details
Trial ID
NCT03397394
Start Date
June 1 2018
End Date
January 15 2020
Last Update
June 9 2023
Active Locations (64)
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1
Pinnacle Oncology, Honor Health
Scottsdale, Arizona, United States, 85258
2
University of California San Diego (UCSD), Moores Cancer Center
La Jolla, California, United States, 92093
3
University of California, Los Angeles (UCLA)
Los Angeles, California, United States, 90095
4
Universityof California, Irvine
Orange, California, United States, 92868