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Trial record 3 of 3 for:    atlas bladder cancer

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 : April 3, 2018
Sponsor:
Collaborator:
Foundation Medicine
Information provided by (Responsible Party):
Clovis Oncology, Inc.

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

Condition or disease Intervention/treatment Phase
Bladder Cancer Urothelial Carcinoma Metastatic Urothelial Carcinoma Renal Pelvis Carcinoma Ureter Carcinoma Urinary Bladder Carcinoma Urethra Carcinoma Muscle Invasive Bladder Cancer Drug: Rucaparib Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Open-label Study of Rucaparib in Patients With Locally Advanced or Metastatic Urothelial Carcinoma
Estimated Study Start Date : March 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : June 2020


Arm Intervention/treatment
Experimental: Rucaparib
Oral rucaparib (monotherapy)
Drug: Rucaparib
Rucaparib will be administered daily.
Other Name: CO-338



Primary Outcome Measures :
  1. Objective response rate (ORR) [ Time Frame: From enrollment to primary completion of study (up to approximately 2 years) ]

Secondary Outcome Measures :
  1. Duration of response (DOR) [ Time Frame: From enrollment to primary completion of study (up to approximately 2 years) ]
  2. Progression-free survival (PFS) [ Time Frame: From enrollment to primary completion of study (up to approximately 2 years) ]
  3. Overall survival (OS) [ Time Frame: From enrollment to primary completion of study (up to approximately 2 years and 6 months) ]
  4. 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) ]
  5. 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) ]
  6. 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) ]
  7. 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) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03397394


Contacts
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

Locations
United States, Connecticut
Eastern Connecticut Hematology & Oncology Associates (ECHO) Recruiting
Norwich, Connecticut, United States, 06360
Contact: Clovis Oncology Clinical Trial Navigation    855-262-3040    clovistrials@emergingmed.com   
United States, Nevada
Comprehensive Cancer Centers of Nevada (CCCN) Recruiting
Las Vegas, Nevada, United States, 89169
Contact: Clovis Oncology Clinical Trial Navigation    855-262-3040    clovistrials@emergingmed.com   
United States, South Carolina
Atlantic Urology Clinics Recruiting
Myrtle Beach, South Carolina, United States, 29572
Contact: Clovis Oncology Clinical Trial Navigation    855-262-3040    clovistrials@emergingmed.com   
United States, Tennessee
Urology Associates Recruiting
Nashville, Tennessee, United States, 37209
Contact: Clovis Oncology Clinical Trial Navigation    855-262-3040    clovistrials@emergingmed.com   
Sponsors and Collaborators
Clovis Oncology, Inc.
Foundation Medicine

Responsible Party: Clovis Oncology, Inc.
ClinicalTrials.gov Identifier: NCT03397394     History of Changes
Other Study ID Numbers: CO-338-085
First Posted: January 12, 2018    Key Record Dates
Last Update Posted: April 3, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Clovis Oncology, Inc.:
ATLAS
PARP inhibitor
PARPi
HRD
homologous recombination
DNA repair
LOH
DNA defect
DNA anomaly
Rucaparib
MIBC

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Carcinoma
Carcinoma, Transitional Cell
Urologic Diseases
Rucaparib
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents