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Rucaparib in Patients With Locally Advanced or Metastatic Urothelial Carcinoma (ATLAS)

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ClinicalTrials.gov Identifier: NCT03397394
Recruitment Status : Recruiting
First Posted : January 12, 2018
Last Update Posted : July 26, 2018
Sponsor:
Collaborator:
Foundation Medicine
Information provided by (Responsible Party):
Clovis Oncology, Inc.

December 21, 2017
January 12, 2018
July 26, 2018
June 1, 2018
December 2019   (Final data collection date for primary outcome measure)
Objective response rate (ORR) [ Time Frame: From enrollment to primary completion of study (up to approximately 2 years) ]
Same as current
Complete list of historical versions of study NCT03397394 on ClinicalTrials.gov Archive Site
  • Duration of response (DOR) [ Time Frame: From enrollment to primary completion of study (up to approximately 2 years) ]
  • Progression-free survival (PFS) [ Time Frame: From enrollment to primary completion of study (up to approximately 2 years) ]
  • Overall survival (OS) [ Time Frame: From enrollment to primary completion of study (up to approximately 2 years and 6 months) ]
  • Number of participants with treatment-related Adverse Events (AEs) as assessed by CTCAE v4.03 as a measure of safety and tolerability [ Time Frame: From enrollment to primary completion of study (up to approximately 2 years and 6 months) ]
  • Number of participants with serious AEs as a measure of safety and tolerability [ Time Frame: From enrollment to primary completion of study (up to approximately 2 years and 6 months) ]
  • Number of participants with worsening laboratory values as a measure of safety and tolerability [ Time Frame: From enrollment to primary completion of study (up to approximately 2 years and 6 months) ]
  • Trough plasma PK (Cmin) of rucaparib based on sparse sampling [ Time Frame: From enrollment to primary completion of study (up to approximately 2 years and 6 months) ]
Same as current
Not Provided
Not Provided
 
Rucaparib in Patients With Locally Advanced or Metastatic Urothelial Carcinoma
A Phase 2, Open-label Study of Rucaparib in Patients With Locally Advanced or Metastatic Urothelial Carcinoma
The purpose of the ATLAS study is to determine how patients with locally advanced or metastatic urothelial carcinoma respond to treatment with rucaparib.
Not Provided
Interventional
Phase 2
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Bladder Cancer
  • Urothelial Carcinoma
  • Metastatic Urothelial Carcinoma
  • Renal Pelvis Carcinoma
  • Ureter Carcinoma
  • Urinary Bladder Carcinoma
  • Urethra Carcinoma
  • Muscle Invasive Bladder Cancer
Drug: Rucaparib
Rucaparib will be administered daily.
Other Name: CO-338
Experimental: Rucaparib
Oral rucaparib (monotherapy)
Intervention: Drug: Rucaparib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
Same as current
June 2020
December 2019   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Have histologically or cytologically confirmed locally advanced or metastatic transitional cell carcinoma of the urothelium (renal pelvis, ureter, urinary bladder or urethra)
  • Received 1 or 2 prior standard of care 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact: Clovis Oncology Clinical Trial Navigation 1-855-262-3040 (USA) clovistrials@emergingmed.com
Contact: Clovis Oncology Clinical Trial Navigation 1-303-625-5160 (non-USA) clovistrials@emergingmed.com
Spain,   United States
 
 
NCT03397394
CO-338-085
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Clovis Oncology, Inc.
Clovis Oncology, Inc.
Foundation Medicine
Not Provided
Clovis Oncology, Inc.
July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP