Summary

for people ages 18 years and up (full criteria)
at La Jolla, California and other locations
study started
estimated completion

Description

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.

Official Title

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

Keywords

Bladder CancerUrothelial CarcinomaMetastatic Urothelial CarcinomaRenal Pelvis CarcinomaUreter CarcinomaUrinary Bladder CarcinomaUrethra CarcinomaMuscle Invasive Bladder CancerPARP inhibitorPARPiHRDATLAShomologous recombinationDNA repairLOHDNA defectDNA anomalyRucaparibMIBCCarcinomaUrinary Bladder NeoplasmsCarcinoma, Transitional Cell

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • University of California San Diego (UCSD), Moores Cancer Centeraccepting new patients
    La JollaCalifornia92093United States
  • Universityof California, Irvineaccepting new patients
    OrangeCalifornia92868United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Clovis Oncology, Inc.
ID
NCT03397394
Phase
Phase 2
Study Type
Interventional
Last Updated