Rucaparib in Patients With Locally Advanced or Metastatic Urothelial Carcinoma

• Status: Terminated
• Trial end date: 2020-01-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Clovis Oncology, Inc.
• Collaborator: Foundation Medicine
• Treatments: Rucaparib

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