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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 unresectable 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 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
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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
Pinnacle Oncology, Honor Health
Scottsdale, Arizona 85258
United States
Recruiting Clovis Oncology Clinical Trial Navigation
855-262-3040
clovistrials@emergingmed.com
University of California San Diego (UCSD), Moores Cancer Center
La Jolla, California 92093
United States
Recruiting Clovis Oncology Clinical Trial Navigation
855-262-3040
clovistrials@emergingmed.com
University of California, Los Angeles (UCLA)
Los Angeles, California 90095
United States
Recruiting Clovis Oncology Clinical Trial Navigation
855-262-3040
clovistrials@emergingmed.com
Universityof California, Irvine
Orange, California 92868
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

Stanford University School of Medicine
Stanford, California 94304
United States
Recruiting Clovis Oncology Clinical Trial Navigation
855-262-3040
clovistrials@emergingmed.com
Hartford Health Care Cancer Institute
Hartford, Connecticut 06102
United States
Recruiting Clovis Oncology Clinical Trial Navigation
855-262-3040
clovistrials@emergingmed.com
Eastern Connecticut Hematology & Oncology Associates (ECHO)
Norwich, Connecticut 06360
United States
Recruiting Clovis Oncology Clinical Trial Navigation
855-262-3040
clovistrials@emergingmed.com
Medstar Georgetown University Medical Center
Washington, District of Columbia 20007
United States
Recruiting Clovis Oncology Clinical Trial Navigation
855-262-3040
clovistrials@emergingmed.com
Miami Cancer Institute, Baptist Health South Florida
Miami, Florida 33176
United States
Recruiting Clovis Oncology Clinical Trial Navigation
855-262-3040
clovistrials@emergingmed.com
Northwestern University, Chicago
Chicago, Illinois 60611
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 Navigation
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
Norton Cancer Center
Louisville, Kentucky 40207
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
Minnesota Oncology Hematology P.A. (USO - US Oncology)
Minneapolis, Minnesota 55404
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
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey 07601
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
New York Oncology Hematology, P.C. (USO - US Oncology)
Albany, New York 12208
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
New York - Presbyterian Hospital-Weill Cornell Medical Center
New York, New York 10021
United States
Recruiting Clovis Oncology Clinical Trial Navigation
855-262-3040
clovistrials@emergingmed.com
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United States
Recruiting Clovis Oncology Clinical Trial Navigation
855-262-3040
clovistrials@emergingmed.com
Duke University, Duke Cancer Institute
Durham, North Carolina 27710
United States
Recruiting Clovis Oncology Clinical Trial Navigation
855-262-3040
clovistrials@emergingmed.com
Stephenson Cancer Center
Oklahoma City, Oklahoma 73104
United States
Recruiting Clovis Oncology Clinical Trial Navigation
855-262-3040
clovistrials@emergingmed.com
Northwest Cancer Specialists P.C. (USO - US Oncology)
Portland, Oregon 97062
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
Oregon Health and Science University
Portland, Oregon 97239
United States
Recruiting Clovis Oncology Clinical Trial Navigation
855-262-3040
clovistrials@emergingmed.com
Lehigh Valley Health Network
Allentown, Pennsylvania 18103
United States
Recruiting Clovis Oncology Clinical Trial Navigation
855-262-3040
clovistrials@emergingmed.com
Penn State Hershey Medical Center
Hershey, Pennsylvania 17033
United States
Recruiting Clovis Oncology Clinical Trial Navigation
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
Texas Oncology PA (USO - US Oncology)
Dallas, Texas 76201
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
Froedtert & Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United States
Recruiting Clovis Oncology Clinical Trial Navigation
855-262-3040
clovistrials@emergingmed.com
Centre de Lutte Contre le Cancer (CLCC) - Universite de Lyon - Centre Leon-Berard
Lyon, 69008
France
Recruiting Clovis Oncology Clinical Trial Navigation
855-262-3040
clovistrials@emergingmed.com
Hopital Saint-Louis
Paris, 75010
France
Recruiting Clovis Oncology Clinical Trial Navigation
855-262-3040
clovistrials@emergingmed.com
Centre de Lutte Contre le Cancer - Institut de Cancerologie de l'Ouest - Rene Gauducheau
Saint-Herblain, 44805
France
Recruiting Clovis Oncology Clinical Trial Navigation
855-262-3040
clovistrials@emergingmed.com
Institut Universitaire du Cancer de Toulouse - Oncopole
Toulouse, 31059
France
Recruiting Clovis Oncology Clinical Trial Navigation
855-262-3040
clovistrials@emergingmed.com
Institut Gustave Roussy
Villejuif, 94805
France
Recruiting Clovis Oncology Clinical Trial Navigation
855-262-3040
clovistrials@emergingmed.com
Urologische und Kinderurologische Universitätsklinik im Malteser
Erlangen, 91054
Germany
Recruiting Clovis Oncology Clinical Trial Navigation
855-262-3040
clovistrials@emergingmed.com
Universitatsklinikum Munster / Urologie und Kinderurologie
Münster, 26133
Germany
Recruiting Clovis Oncology Clinical Trial Navigation
855-262-3040
clovistrials@emergingmed.com
Studienpraxis Urologie
Nurtingen, 72622
Germany
Recruiting Clovis Oncology Clinical Trial Navigation
855-262-3040
clovistrials@emergingmed.com
Fondazionerca sul Cancro ONLUS - Istituto di Candiolo IRCCS
Candiolo, 10060
Italy
Recruiting Clovis Oncology Clinical Trial Navigation
855-262-3040
clovistrials@emergingmed.com
IRCCS Ospedale San Raffaele - Medical Oncology Dept
Milano, 20132
Italy
Recruiting Clovis Oncology Clinical Trial Navigation
855-262-3040
clovistrials@emergingmed.com
Fondazione IRCCS Istituto Nazionale Tumori
Milano, 20133
Italy
Recruiting Clovis Oncology Clinical Trial Navigation
855-262-3040
clovistrials@emergingmed.com
Azienda Ospedaliera Universitaria Federico II Oncologia Medica
Naples, 80131
Italy
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 Santa Creu i Sant Pau
Barcelona, 08025
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
Hospital General Universitario Gregorio Maranon
Madrid, 28007
Spain
Recruiting Clovis Oncology Clinical Trial Navigation
855-262-3040
clovistrials@emergingmed.com
Clinica Universitaria de Navarra Madrid
Madrid, 28027
Spain
Recruiting Clovis Oncology Clinical Trial Navigation
855-262-3040
clovistrials@emergingmed.com
MD Anderson Cancer Center
Madrid, 28033
Spain
Recruiting Clovis Oncology Clinical Trial Navigation
855-262-3040
clovistrials@emergingmed.com
Hospital Universitario 12 de Octubre
Madrid, 28041
Spain
Recruiting Clovis Oncology Clinical Trial Navigation
855-262-3040
clovistrials@emergingmed.com
Hospital Clínico Universitario de Santiago de Compostela
Santiago De Compostela, 15706
Spain
Recruiting Clovis Oncology Clinical Trial Navigation
855-262-3040
clovistrials@emergingmed.com
Sarah Cannon Research Institute - United Kingdom - London Office
London, CH63 4JY
United Kingdom
Recruiting Clovis Oncology Clinical Trial Navigation
855-262-3040
clovistrials@emergingmed.com
Guy's & St. Thomas' Hospital (London Oncology Clinic)
London, W1G 6AF
United Kingdom
Recruiting Clovis Oncology Clinical Trial Navigation
855-262-3040
clovistrials@emergingmed.com