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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03397394
Recruitment Status : Suspended (Efficacy did not meet the continuance criteria and DMC recommended to stop enrollment.)
First Posted : January 12, 2018
Last Update Posted : April 23, 2019
Sponsor:
Collaborator:
Foundation Medicine
Information provided by (Responsible Party):
Clovis Oncology, Inc.

Tracking Information
First Submitted Date  ICMJE December 21, 2017
First Posted Date  ICMJE January 12, 2018
Last Update Posted Date April 23, 2019
Actual Study Start Date  ICMJE June 1, 2018
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 5, 2018)
Objective response rate (ORR) [ Time Frame: From enrollment to primary completion of study (up to approximately 2 years) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03397394 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 5, 2018)
  • 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) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Rucaparib in Patients With Locally Advanced or Metastatic Urothelial Carcinoma
Official Title  ICMJE A Phase 2, Open-label Study of Rucaparib in Patients With Locally Advanced or Metastatic Urothelial Carcinoma
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Bladder Cancer
  • Urothelial Carcinoma
  • Metastatic Urothelial Carcinoma
  • Renal Pelvis Carcinoma
  • Ureter Carcinoma
  • Urinary Bladder Carcinoma
  • Urethra Carcinoma
  • Muscle Invasive Bladder Cancer
Intervention  ICMJE Drug: Rucaparib
Rucaparib will be administered daily.
Other Name: CO-338
Study Arms  ICMJE Experimental: Rucaparib
Oral rucaparib (monotherapy)
Intervention: Drug: Rucaparib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Actual Enrollment  ICMJE
 (submitted: April 19, 2019)
98
Original Estimated Enrollment  ICMJE
 (submitted: January 5, 2018)
200
Estimated Study Completion Date  ICMJE June 2020
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   Germany,   Italy,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03397394
Other Study ID Numbers  ICMJE CO-338-085
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Clovis Oncology, Inc.
Study Sponsor  ICMJE Clovis Oncology, Inc.
Collaborators  ICMJE Foundation Medicine
Investigators  ICMJE Not Provided
PRS Account Clovis Oncology, Inc.
Verification Date April 2019

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