Rucaparib in Patients With Locally Advanced or Metastatic Urothelial Carcinoma

Trial ID or NCT#

NCT03397394

Status

not recruiting iconNOT RECRUITING

Purpose

The purpose of the ATLAS study is to determine how patients with locally advanced unresectable or metastatic urothelial carcinoma respond to treatment with rucaparib.

Official Title

A Phase 2, Open-label Study of Rucaparib in Patients With Locally Advanced or Metastatic Urothelial Carcinoma

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * 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:
  1. * 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

Investigator(s)

Sandy Srinivas
Sandy Srinivas
Medical oncologist, Urologic specialist, Genitourinary specialist
Professor of Medicine (Oncology) and, by courtesy, of Urology

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Contact

CCTO
650-498-7061