Study Stopped
Efficacy did not meet the continuance criteria and DMC recommended to stop enrollment.
Rucaparib in Patients With Locally Advanced or Metastatic Urothelial Carcinoma
ATLAS
A Phase 2, Open-label Study of Rucaparib in Patients With Locally Advanced or Metastatic Urothelial Carcinoma
2 other identifiers
interventional
97
6 countries
64
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2018
64 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 21, 2017
CompletedFirst Posted
Study publicly available on registry
January 12, 2018
CompletedStudy Start
First participant enrolled
June 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 12, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 15, 2020
CompletedResults Posted
Study results publicly available
October 19, 2020
CompletedJune 9, 2023
June 1, 2023
1.5 years
December 21, 2017
July 31, 2020
June 7, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Objective Response Rate (ORR) Per RECIST Version 1.1
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.
Time from first dose to date of progression, up to approximately 19 months
Secondary Outcomes (3)
Progression-free Survival (PFS) According to RECIST v1.1, as Assessed by the Investigator
Cycle 1 Day 1 to End of Treatment, up to approximately 10 months
Overall Survival
The total study time for reporting of deaths was approximately 19 months.
Pharmacokinetics - Trough (Cmin) Level Rucaparib Concentrations
From Cycle 2 Day 1 to Cycle 4 Day 1, or approximately 2 months
Study Arms (1)
Rucaparib
EXPERIMENTALOral rucaparib (monotherapy)
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- pharmaand GmbHlead
- Foundation Medicinecollaborator
Study Sites (64)
Pinnacle Oncology, Honor Health
Scottsdale, Arizona, 85258, United States
University of California San Diego (UCSD), Moores Cancer Center
La Jolla, California, 92093, United States
University of California, Los Angeles (UCLA)
Los Angeles, California, 90095, United States
Universityof California, Irvine
Orange, California, 92868, United States
Saint John's Health Center - John Wayne Cancer Institute (JWCI)
Santa Monica, California, 90404, United States
Stanford University School of Medicine
Stanford, California, 94304, United States
Hartford Health Care Cancer Institute
Hartford, Connecticut, 06102, United States
Eastern Connecticut Hematology & Oncology Associates (ECHO)
Norwich, Connecticut, 06360, United States
Medstar Georgetown University Medical Center
Washington D.C., District of Columbia, 20007, United States
Miami Cancer Institute, Baptist Health South Florida
Miami, Florida, 33176, United States
Northwestern University, Chicago
Chicago, Illinois, 60611, United States
Indiana University - Melvin and Bren Simon Cancer Center (IUSCC)
Indianapolis, Indiana, 46202, United States
The University of Iowa and Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242, United States
Norton Cancer Center
Louisville, Kentucky, 40207, United States
Ochsner Cancer Institute
New Orleans, Louisiana, 70121, United States
University of Maryland, Marlene and Stewart Greenebaum Cancer Center
Baltimore, Maryland, 21201, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Minnesota Oncology Hematology P.A. (USO - US Oncology)
Minneapolis, Minnesota, 55404, United States
Comprehensive Cancer Centers of Nevada (CCCN)
Las Vegas, Nevada, 89169, United States
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
University of New Mexico UNM Cancer Research and Treatment Center
Albuquerque, New Mexico, 87102, United States
New York Oncology Hematology, P.C. (USO - US Oncology)
Albany, New York, 12208, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
New York - Presbyterian Hospital-Weill Cornell Medical Center
New York, New York, 10021, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Duke University, Duke Cancer Institute
Durham, North Carolina, 27710, United States
Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104, United States
Northwest Cancer Specialists P.C. (USO - US Oncology)
Portland, Oregon, 97062, United States
Providence Portland Medical Center
Portland, Oregon, 97213, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Lehigh Valley Health Network
Allentown, Pennsylvania, 18103, United States
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Atlantic Urology Clinics
Myrtle Beach, South Carolina, 29572, United States
University Oncology & Hematology
Chattanooga, Tennessee, 37403, United States
Urology Associates
Nashville, Tennessee, 37209, United States
Texas Oncology PA (USO - US Oncology)
Dallas, Texas, 76201, United States
University of Texas, UT Health Science Center
Houston, Texas, 77030, United States
University of Utah, Huntsman Cancer Institute
Salt Lake City, Utah, 84112, United States
University of Virginia, Emily Couric Clinical Center
Charlottesville, Virginia, 22908, United States
University of Washington / Seattle Cancer Care Alliance
Seattle, Washington, 98109, United States
Froedtert & Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Centre de Lutte Contre le Cancer (CLCC) - Universite de Lyon - Centre Leon-Berard
Lyon, 69008, France
Hopital Saint-Louis
Paris, 75010, France
Centre de Lutte Contre le Cancer - Institut de Cancerologie de l'Ouest - Rene Gauducheau
Saint-Herblain, 44805, France
Institut Universitaire du Cancer de Toulouse - Oncopole
Toulouse, 31059, France
Institut Gustave Roussy
Villejuif, 94805, France
Urologische und Kinderurologische Universitätsklinik im Malteser
Erlangen, 91054, Germany
Universitatsklinikum Munster / Urologie und Kinderurologie
Münster, 26133, Germany
Studienpraxis Urologie
Nürtingen, 72622, Germany
Fondazionerca sul Cancro ONLUS - Istituto di Candiolo IRCCS
Candiolo, 10060, Italy
IRCCS Ospedale San Raffaele - Medical Oncology Dept
Milan, 20132, Italy
Fondazione IRCCS Istituto Nazionale Tumori
Milan, 20133, Italy
Azienda Ospedaliera Universitaria Federico II Oncologia Medica
Naples, 80131, Italy
Universidad de Navarra - Clinica Universitaria de Navarra
Pamplona, Navarre, 31008, Spain
Hospital del Mar
Barcelona, 08003, Spain
Hospital Santa Creu i Sant Pau
Barcelona, 08025, Spain
Hospital Universitari Vall d'Hebron de Barcelona
Barcelona, 08035, Spain
Hospital General Universitario Gregorio Maranon
Madrid, 28007, Spain
Clinica Universitaria de Navarra Madrid
Madrid, 28027, Spain
MD Anderson Cancer Center
Madrid, 28033, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Clínico Universitario de Santiago de Compostela
Santiago de Compostela, 15706, Spain
Sarah Cannon Research Institute - United Kingdom - London Office
London, CH63 4JY, United Kingdom
Guy's & St. Thomas' Hospital (London Oncology Clinic)
London, W1G 6AF, United Kingdom
Related Publications (1)
Grivas P, Loriot Y, Morales-Barrera R, Teo MY, Zakharia Y, Feyerabend S, Vogelzang NJ, Grande E, Adra N, Alva A, Necchi A, Rodriguez-Vida A, Gupta S, Josephs DH, Srinivas S, Wride K, Thomas D, Simmons A, Loehr A, Dusek RL, Nepert D, Chowdhury S. Efficacy and safety of rucaparib in previously treated, locally advanced or metastatic urothelial carcinoma from a phase 2, open-label trial (ATLAS). BMC Cancer. 2021 May 24;21(1):593. doi: 10.1186/s12885-021-08085-z.
PMID: 34030643DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The study was terminated early based on an interim analysis by the Data Monitoring Committee that demonstrated that ORR did not meet the protocol-defined continuance criteria. There were no confirmed responses observed.
Results Point of Contact
- Title
- Medical Information Department
- Organization
- Clovis Oncology, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 21, 2017
First Posted
January 12, 2018
Study Start
June 1, 2018
Primary Completion
December 12, 2019
Study Completion
January 15, 2020
Last Updated
June 9, 2023
Results First Posted
October 19, 2020
Record last verified: 2023-06