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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.

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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 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
Actual Study Start Date : June 1, 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, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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


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Locations
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United States, Arizona
Pinnacle Oncology, Honor Health
Scottsdale, Arizona, United States, 85258
United States, California
University of California San Diego (UCSD), Moores Cancer Center
La Jolla, California, United States, 92093
University of California, Los Angeles (UCLA)
Los Angeles, California, United States, 90095
Universityof California, Irvine
Orange, California, United States, 92868
Saint John's Health Center - John Wayne Cancer Institute (JWCI)
Santa Monica, California, United States, 90404
Stanford University School of Medicine
Stanford, California, United States, 94304
United States, Connecticut
Hartford Health Care Cancer Institute
Hartford, Connecticut, United States, 06102
Eastern Connecticut Hematology & Oncology Associates (ECHO)
Norwich, Connecticut, United States, 06360
United States, District of Columbia
Medstar Georgetown University Medical Center
Washington, District of Columbia, United States, 20007
United States, Florida
Miami Cancer Institute, Baptist Health South Florida
Miami, Florida, United States, 33176
United States, Illinois
Northwestern University, Chicago
Chicago, Illinois, United States, 60611
United States, Indiana
Indiana University - Melvin and Bren Simon Cancer Center (IUSCC)
Indianapolis, Indiana, United States, 46202
United States, Iowa
The University of Iowa and Holden Comprehensive Cancer Center
Iowa City, Iowa, United States, 52242
United States, Kentucky
Norton Cancer Center
Louisville, Kentucky, United States, 40207
United States, Louisiana
Ochsner Cancer Institute
New Orleans, Louisiana, United States, 70121
United States, Maryland
University of Maryland, Marlene and Stewart Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, Minnesota
Minnesota Oncology Hematology P.A. (USO - US Oncology)
Minneapolis, Minnesota, United States, 55404
United States, Nevada
Comprehensive Cancer Centers of Nevada (CCCN)
Las Vegas, Nevada, United States, 89169
United States, New Jersey
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, New Mexico
University of New Mexico UNM Cancer Research and Treatment Center
Albuquerque, New Mexico, United States, 87102
United States, New York
New York Oncology Hematology, P.C. (USO - US Oncology)
Albany, New York, United States, 12208
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
New York - Presbyterian Hospital-Weill Cornell Medical Center
New York, New York, United States, 10021
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, North Carolina
Duke University, Duke Cancer Institute
Durham, North Carolina, United States, 27710
United States, Oklahoma
Stephenson Cancer Center
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Northwest Cancer Specialists P.C. (USO - US Oncology)
Portland, Oregon, United States, 97062
Providence Portland Medical Center
Portland, Oregon, United States, 97213
Oregon Health and Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
Lehigh Valley Health Network
Allentown, Pennsylvania, United States, 18103
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
United States, South Carolina
Atlantic Urology Clinics
Myrtle Beach, South Carolina, United States, 29572
United States, Tennessee
University Oncology & Hematology
Chattanooga, Tennessee, United States, 37403
Urology Associates
Nashville, Tennessee, United States, 37209
United States, Texas
Texas Oncology PA (USO - US Oncology)
Dallas, Texas, United States, 76201
University of Texas, UT Health Science Center
Houston, Texas, United States, 77030
United States, Utah
University of Utah, Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
United States, Virginia
University of Virginia, Emily Couric Clinical Center
Charlottesville, Virginia, United States, 22908
United States, Washington
University of Washington / Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
United States, Wisconsin
Froedtert & Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
France
Centre de Lutte Contre le Cancer (CLCC) - Universite de Lyon - Centre Leon-Berard
Lyon, France, 69008
Hopital Saint-Louis
Paris, France, 75010
Centre de Lutte Contre le Cancer - Institut de Cancerologie de l'Ouest - Rene Gauducheau
Saint-Herblain, France, 44805
Institut Universitaire du Cancer de Toulouse - Oncopole
Toulouse, France, 31059
Institut Gustave Roussy
Villejuif, France, 94805
Germany
Urologische und Kinderurologische Universitätsklinik im Malteser
Erlangen, Germany, 91054
Universitatsklinikum Munster / Urologie und Kinderurologie
Münster, Germany, 26133
Studienpraxis Urologie
Nurtingen, Germany, 72622
Italy
Fondazionerca sul Cancro ONLUS - Istituto di Candiolo IRCCS
Candiolo, Italy, 10060
IRCCS Ospedale San Raffaele - Medical Oncology Dept
Milano, Italy, 20132
Fondazione IRCCS Istituto Nazionale Tumori
Milano, Italy, 20133
Azienda Ospedaliera Universitaria Federico II Oncologia Medica
Naples, Italy, 80131
Spain
Universidad de Navarra - Clinica Universitaria de Navarra
Pamplona, Navarre, Spain, 31008
Hospital del Mar
Barcelona, Spain, 08003
Hospital Santa Creu i Sant Pau
Barcelona, Spain, 08025
Hospital Universitari Vall d'Hebron de Barcelona
Barcelona, Spain, 08035
Hospital General Universitario Gregorio Maranon
Madrid, Spain, 28007
Clinica Universitaria de Navarra Madrid
Madrid, Spain, 28027
MD Anderson Cancer Center
Madrid, Spain, 28033
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Hospital Clínico Universitario de Santiago de Compostela
Santiago De Compostela, Spain, 15706
United Kingdom
Sarah Cannon Research Institute - United Kingdom - London Office
London, United Kingdom, CH63 4JY
Guy's & St. Thomas' Hospital (London Oncology Clinic)
London, United Kingdom, W1G 6AF
Sponsors and Collaborators
Clovis Oncology, Inc.
Foundation Medicine

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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 23, 2019
Last Verified: April 2019

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

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

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