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Rucaparib in Patients With Locally Advanced or Metastatic Urothelial Carcinoma
Trial Status: administratively complete
The purpose of the ATLAS study is to determine how patients with locally advanced
unresectable or metastatic urothelial carcinoma respond to treatment with rucaparib.
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
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03397394.