- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03397394
Rucaparib in Patients With Locally Advanced or Metastatic Urothelial Carcinoma (ATLAS)
June 7, 2023 updated by: zr Pharma & GmbH
A Phase 2, Open-label Study of Rucaparib in Patients With Locally Advanced or Metastatic Urothelial Carcinoma
The purpose of the ATLAS study is to determine how patients with locally advanced unresectable or metastatic urothelial carcinoma respond to treatment with rucaparib.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
97
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Lyon, France, 69008
- Centre de Lutte Contre le Cancer (CLCC) - Universite de Lyon - Centre Leon-Berard
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Paris, France, 75010
- Hôpital Saint-Louis
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Saint-Herblain, France, 44805
- Centre de Lutte Contre Le Cancer - Institut de Cancerologie de L'Ouest - Rene Gauducheau
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Toulouse, France, 31059
- Institut Universitaire du Cancer de Toulouse - Oncopole
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Villejuif, France, 94805
- Institut Gustave Roussy
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Erlangen, Germany, 91054
- Urologische und Kinderurologische Universitätsklinik im Malteser
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Münster, Germany, 26133
- Universitatsklinikum Munster / Urologie und Kinderurologie
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Nurtingen, Germany, 72622
- Studienpraxis Urologie
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Candiolo, Italy, 10060
- Fondazionerca sul Cancro ONLUS - Istituto di Candiolo IRCCS
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Milano, Italy, 20133
- Fondazione IRCCS Istituto Nazionale Tumori
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Milano, Italy, 20132
- IRCCS Ospedale San Raffaele - Medical Oncology Dept
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Naples, Italy, 80131
- Azienda Ospedaliera Universitaria Federico II Oncologia Medica
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Barcelona, Spain, 08003
- Hospital del Mar
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Barcelona, Spain, 08025
- Hospital Santa Creu i Sant Pau
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Barcelona, Spain, 08035
- Hospital Universitari Vall d'Hebron de Barcelona
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Madrid, Spain, 28041
- Hospital Universitario 12 de Octubre
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Madrid, Spain, 28007
- Hospital General Universitario Gregorio Marañon
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Madrid, Spain, 28033
- MD Anderson Cancer Center
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Madrid, Spain, 28027
- Clinica Universitaria de Navarra Madrid
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Santiago De Compostela, Spain, 15706
- Hospital Clínico Universitario de Santiago de Compostela
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Navarre
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Pamplona, Navarre, Spain, 31008
- Universidad de Navarra - Clinica Universitaria de Navarra
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London, United Kingdom, CH63 4JY
- Sarah Cannon Research Institute - United Kingdom - London Office
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London, United Kingdom, W1G 6AF
- Guy's & St. Thomas' Hospital (London Oncology Clinic)
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Arizona
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Scottsdale, Arizona, United States, 85258
- Pinnacle Oncology, Honor Health
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California
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La Jolla, California, United States, 92093
- University of California San Diego (UCSD), Moores Cancer Center
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Los Angeles, California, United States, 90095
- University of California, Los Angeles (UCLA)
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Orange, California, United States, 92868
- Universityof California, Irvine
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Santa Monica, California, United States, 90404
- Saint John's Health Center - John Wayne Cancer Institute (JWCI)
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Stanford, California, United States, 94304
- Stanford University School of Medicine
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Connecticut
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Hartford, Connecticut, United States, 06102
- Hartford Health Care Cancer Institute
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Norwich, Connecticut, United States, 06360
- Eastern Connecticut Hematology & Oncology Associates (ECHO)
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District of Columbia
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Washington, District of Columbia, United States, 20007
- MedStar Georgetown University Medical Center
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Florida
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Miami, Florida, United States, 33176
- Miami Cancer Institute, Baptist Health South Florida
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Illinois
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Chicago, Illinois, United States, 60611
- Northwestern University, Chicago
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Indiana
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Indianapolis, Indiana, United States, 46202
- Indiana University - Melvin and Bren Simon Cancer Center (IUSCC)
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Iowa
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Iowa City, Iowa, United States, 52242
- The University of Iowa and Holden Comprehensive Cancer Center
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Kentucky
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Louisville, Kentucky, United States, 40207
- Norton Cancer Center
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Louisiana
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New Orleans, Louisiana, United States, 70121
- Ochsner Cancer Institute
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Maryland
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Baltimore, Maryland, United States, 21201
- University of Maryland, Marlene and Stewart Greenebaum Cancer Center
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Michigan
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Ann Arbor, Michigan, United States, 48109
- University of Michigan
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Minnesota
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Minneapolis, Minnesota, United States, 55404
- Minnesota Oncology Hematology P.A. (USO - US Oncology)
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Nevada
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Las Vegas, Nevada, United States, 89169
- Comprehensive Cancer Centers of Nevada (CCCN)
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New Jersey
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Hackensack, New Jersey, United States, 07601
- John Theurer Cancer Center at Hackensack University Medical Center
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New Mexico
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Albuquerque, New Mexico, United States, 87102
- University of New Mexico UNM Cancer Research and Treatment Center
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New York
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Albany, New York, United States, 12208
- New York Oncology Hematology, P.C. (USO - US Oncology)
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Buffalo, New York, United States, 14263
- Roswell Park Cancer Institute
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New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
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New York, New York, United States, 10021
- New York - Presbyterian Hospital-Weill Cornell Medical Center
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke University, Duke Cancer Institute
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73104
- Stephenson Cancer Center
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Oregon
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Portland, Oregon, United States, 97239
- Oregon Health and Science University
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Portland, Oregon, United States, 97213
- Providence Portland Medical Center
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Portland, Oregon, United States, 97062
- Northwest Cancer Specialists P.C. (USO - US Oncology)
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Pennsylvania
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Allentown, Pennsylvania, United States, 18103
- Lehigh Valley Health Network
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Hershey, Pennsylvania, United States, 17033
- Penn State Hershey Medical Center
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South Carolina
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Myrtle Beach, South Carolina, United States, 29572
- Atlantic Urology Clinics
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Tennessee
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Chattanooga, Tennessee, United States, 37403
- University Oncology & Hematology
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Nashville, Tennessee, United States, 37209
- Urology Associates
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Texas
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Dallas, Texas, United States, 76201
- Texas Oncology PA (USO - US Oncology)
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Houston, Texas, United States, 77030
- University of Texas, UT Health Science Center
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Utah
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Salt Lake City, Utah, United States, 84112
- University of Utah, Huntsman Cancer Institute
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Virginia
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Charlottesville, Virginia, United States, 22908
- University of Virginia, Emily Couric Clinical Center
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Washington
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Seattle, Washington, United States, 98109
- University of Washington / Seattle Cancer Care Alliance
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Wisconsin
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Milwaukee, Wisconsin, United States, 53226
- Froedtert & Medical College of Wisconsin
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Rucaparib
Oral rucaparib (monotherapy)
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Rucaparib will be administered daily.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective Response Rate (ORR) Per RECIST Version 1.1
Time Frame: Time from first dose to date of progression, up to approximately 19 months
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ORR is defined as the proportion of patients with a confirmed response of complete response (CR) or partial response (PR) by RECIST v1.1 as assessed by the investigator.
Complete Response (CR) is disappearance of all target lesions.
Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.
Partial Response (PR), is at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter.
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Time from first dose to date of progression, up to approximately 19 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free Survival (PFS) According to RECIST v1.1, as Assessed by the Investigator
Time Frame: Cycle 1 Day 1 to End of Treatment, up to approximately 10 months
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PFS is calculated as 1+ the number of days from the first dose of study drug to disease progression by RECIST, as determined by the investigator or death due to any cause, whichever occurs first.
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Cycle 1 Day 1 to End of Treatment, up to approximately 10 months
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Overall Survival
Time Frame: The total study time for reporting of deaths was approximately 19 months.
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Overall survival (OS) was defined as time from the date of first dose of rucaparib to the date of death due to any cause.
Patients without a known date of death were to be censored on the date the patient was last known to be alive.
A Kaplan-Meier analysis of OS was planned, however, due to early study termination and limited duration of OS follow-up, a descriptive summary of total deaths are presented.
This includes deaths recorded on study (from first dose of study drug until 28 days after last dose of study drug), and deaths recorded in long-term follow-up (from last dose +28 days until death, loss to follow-up, withdrawal of consent, or study closure).
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The total study time for reporting of deaths was approximately 19 months.
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Pharmacokinetics - Trough (Cmin) Level Rucaparib Concentrations
Time Frame: From Cycle 2 Day 1 to Cycle 4 Day 1, or approximately 2 months
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Plasma were collected for trough level PK analysis of rucaparib 1 hour before the morning dose on Cycle 2 Day 1, Cycle 3 Day 1, and Cycle 4 Day 1.
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From Cycle 2 Day 1 to Cycle 4 Day 1, or approximately 2 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2018
Primary Completion (Actual)
December 12, 2019
Study Completion (Actual)
January 15, 2020
Study Registration Dates
First Submitted
December 21, 2017
First Submitted That Met QC Criteria
January 5, 2018
First Posted (Actual)
January 12, 2018
Study Record Updates
Last Update Posted (Actual)
June 9, 2023
Last Update Submitted That Met QC Criteria
June 7, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Urologic Diseases
- Neoplasms, Glandular and Epithelial
- Urinary Bladder Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Carcinoma
- Urinary Bladder Neoplasms
- Carcinoma, Transitional Cell
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Poly(ADP-ribose) Polymerase Inhibitors
- Rucaparib
Other Study ID Numbers
- CO-338-085
- 2017-004166-10 (EudraCT Number)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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