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BRIEF TITLE: A Phase 2, Open-label Study of 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


  • Org Study ID: CO-338-085
  • Secondary ID:
  • NCT ID: NCT03397394
  • NCT Alias:
  • Sponsor: Clovis Oncology, Inc. - Industry
  • Source: 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.

Overal Status Start Date Phase Study Type
Recruiting June 1, 2018 Phase 2 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Objective response rate (ORR)

Primary Outcome 1 - Time Frame: From enrollment to primary completion of study (up to approximately 2 years)

Condition:

  • Bladder Cancer
  • Urothelial Carcinoma
  • Metastatic Urothelial Carcinoma
  • Renal Pelvis Carcinoma
  • Ureter Carcinoma
  • Urinary Bladder Carcinoma
  • Urethra Carcinoma
  • Muscle Invasive Bladder Cancer

Eligibility

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
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Contact

Name: Clovis Oncology Clinical Trial Navigation

Phone: 1-855-262-3040 (USA)

Email: clovistrials@emergingmed.com

Locations

Facility Status Contact
University of California, Los Angeles (UCLA)
Los Angeles, California 90095
United States
Recruiting Clovis Oncology Clinical Trial Navigation
855-262-3040
clovistrials@emergingmed.com
Saint John's Health Center - John Wayne Cancer Institute (JWCI)
Santa Monica, California 90404
United States
Recruiting Clovis Oncology Clinical Trial Navigation

Eastern Connecticut Hematology & Oncology Associates (ECHO)
Norwich, Connecticut 06360
United States
Recruiting Clovis Oncology Clinical Trial Navigation
855-262-3040
clovistrials@emergingmed.com
Indiana University - Melvin and Bren Simon Cancer Center (IUSCC)
Indianapolis, Indiana 46202
United States
Recruiting Clovis Oncology Clinical Trial Navigatio
855-262-3040
clovistrials@emergingmed.com
The University of Iowa and Holden Comprehensive Cancer Center
Iowa City, Iowa 52242
United States
Recruiting Clovis Oncology Clinical Trial Navigation
855-262-3040
clovistrials@emergingmed.com
Ochsner Cancer Institute
New Orleans, Louisiana 70121
United States
Recruiting Clovis Oncology Clinical Trial Navigation
855-262-3040
clovistrials@emergingmed.com
University of Maryland, Marlene and Stewart Greenebaum Cancer Center
Baltimore, Maryland 21201
United States
Recruiting Clovis Oncology Clinical Trial Navigation
855-262-3040
clovistrials@emergingmed.com
University of Michigan
Ann Arbor, Michigan 48109
United States
Recruiting Clovis Oncology Clinical Trial Navigation
855-262-3040
clovistrials@emergingmed.com
Comprehensive Cancer Centers of Nevada (CCCN)
Las Vegas, Nevada 89169
United States
Recruiting Clovis Oncology Clinical Trial Navigation
855-262-3040
clovistrials@emergingmed.com
University of New Mexico UNM Cancer Research and Treatment Center
Albuquerque, New Mexico 87102
United States
Recruiting Clovis Oncology Clinical Trial Navigation
855-262-3040
clovistrials@emergingmed.com
Roswell Park Cancer Institute
Buffalo, New York 14263
United States
Recruiting Clovis Oncology Clinical Trial Navigation
855-262-3040
clovistrials@emergingmed.com
Providence Portland Medical Center
Portland, Oregon 97213
United States
Recruiting Clovis Oncology Clinical Trial Navigatio
855-262-3040
clovistrials@emergingmed.com
Atlantic Urology Clinics
Myrtle Beach, South Carolina 29572
United States
Recruiting Clovis Oncology Clinical Trial Navigation
855-262-3040
clovistrials@emergingmed.com
University Oncology & Hematology
Chattanooga, Tennessee 37403
United States
Recruiting Clovis Oncology Clinical Trial Navigation

Urology Associates
Nashville, Tennessee 37209
United States
Recruiting Clovis Oncology Clinical Trial Navigation
855-262-3040
clovistrials@emergingmed.com
University of Texas, UT Health Science Center
Houston, Texas 77030
United States
Recruiting Clovis Oncology Clinical Trial Navigation
855-262-3040
clovistrials@emergingmed.com
University of Utah, Huntsman Cancer Institute
Salt Lake City, Utah 84112
United States
Recruiting Clovis Oncology Clinical Trial Navigation
855-262-3040
clovistrials@emergingmed.com
University of Virginia, Emily Couric Clinical Center
Charlottesville, Virginia 22908
United States
Recruiting Clovis Oncology Clinical Trial Navigation

University of Washington / Seattle Cancer Care Alliance
Seattle, Washington 98109
United States
Recruiting Clovis Oncology Clinical Trial Navigation
855-262-3040
clovistrials@emergingmed.com
Universidad de Navarra - Clinica Universitaria de Navarra
Pamplona, Navarre 31008
Spain
Recruiting Clovis Oncology Clinical Trial Navigation
855-262-3040
clovistrials@emergingmed.com
Hospital del Mar
Barcelona, 08003
Spain
Recruiting Clovis Oncology Clinical Trial Navigation
855-262-3040
clovistrials@emergingmed.com
Hospital Universitari Vall d'Hebron de Barcelona
Barcelona, 08035
Spain
Recruiting Clovis Oncology Clinical Trial Navigation
855-262-3040
clovistrials@emergingmed.com