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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03397394
Other study ID # CO-338-085
Secondary ID 2017-004166-10
Status Terminated
Phase Phase 2
First received
Last updated
Start date June 1, 2018
Est. completion date January 15, 2020

Study information

Verified date June 2023
Source zr Pharma & GmbH
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 97
Est. completion date January 15, 2020
Est. primary completion date December 12, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Drug:
Rucaparib
Rucaparib will be administered daily.

Locations

Country Name City State
France Centre de Lutte Contre le Cancer (CLCC) - Universite de Lyon - Centre Leon-Berard Lyon
France Hopital Saint-Louis Paris
France Centre de Lutte Contre le Cancer - Institut de Cancerologie de l'Ouest - Rene Gauducheau Saint-Herblain
France Institut Universitaire du Cancer de Toulouse - Oncopole Toulouse
France Institut Gustave Roussy Villejuif
Germany Urologische und Kinderurologische Universitätsklinik im Malteser Erlangen
Germany Universitatsklinikum Munster / Urologie und Kinderurologie Münster
Germany Studienpraxis Urologie Nurtingen
Italy Fondazionerca sul Cancro ONLUS - Istituto di Candiolo IRCCS Candiolo
Italy Fondazione IRCCS Istituto Nazionale Tumori Milano
Italy IRCCS Ospedale San Raffaele - Medical Oncology Dept Milano
Italy Azienda Ospedaliera Universitaria Federico II Oncologia Medica Naples
Spain Hospital del Mar Barcelona
Spain Hospital Santa Creu i Sant Pau Barcelona
Spain Hospital Universitari Vall d'Hebron de Barcelona Barcelona
Spain Clinica Universitaria de Navarra Madrid Madrid
Spain Hospital General Universitario Gregorio Maranon Madrid
Spain Hospital Universitario 12 de Octubre Madrid
Spain MD Anderson Cancer Center Madrid
Spain Universidad de Navarra - Clinica Universitaria de Navarra Pamplona Navarre
Spain Hospital Clínico Universitario de Santiago de Compostela Santiago De Compostela
United Kingdom Guy's & St. Thomas' Hospital (London Oncology Clinic) London
United Kingdom Sarah Cannon Research Institute - United Kingdom - London Office London
United States New York Oncology Hematology, P.C. (USO - US Oncology) Albany New York
United States University of New Mexico UNM Cancer Research and Treatment Center Albuquerque New Mexico
United States Lehigh Valley Health Network Allentown Pennsylvania
United States University of Michigan Ann Arbor Michigan
United States University of Maryland, Marlene and Stewart Greenebaum Cancer Center Baltimore Maryland
United States Roswell Park Cancer Institute Buffalo New York
United States University of Virginia, Emily Couric Clinical Center Charlottesville Virginia
United States University Oncology & Hematology Chattanooga Tennessee
United States Northwestern University, Chicago Chicago Illinois
United States Texas Oncology PA (USO - US Oncology) Dallas Texas
United States Duke University, Duke Cancer Institute Durham North Carolina
United States John Theurer Cancer Center at Hackensack University Medical Center Hackensack New Jersey
United States Hartford Health Care Cancer Institute Hartford Connecticut
United States Penn State Hershey Medical Center Hershey Pennsylvania
United States University of Texas, UT Health Science Center Houston Texas
United States Indiana University - Melvin and Bren Simon Cancer Center (IUSCC) Indianapolis Indiana
United States The University of Iowa and Holden Comprehensive Cancer Center Iowa City Iowa
United States University of California San Diego (UCSD), Moores Cancer Center La Jolla California
United States Comprehensive Cancer Centers of Nevada (CCCN) Las Vegas Nevada
United States University of California, Los Angeles (UCLA) Los Angeles California
United States Norton Cancer Center Louisville Kentucky
United States Miami Cancer Institute, Baptist Health South Florida Miami Florida
United States Froedtert & Medical College of Wisconsin Milwaukee Wisconsin
United States Minnesota Oncology Hematology P.A. (USO - US Oncology) Minneapolis Minnesota
United States Atlantic Urology Clinics Myrtle Beach South Carolina
United States Urology Associates Nashville Tennessee
United States Ochsner Cancer Institute New Orleans Louisiana
United States Memorial Sloan Kettering Cancer Center New York New York
United States New York - Presbyterian Hospital-Weill Cornell Medical Center New York New York
United States Eastern Connecticut Hematology & Oncology Associates (ECHO) Norwich Connecticut
United States Stephenson Cancer Center Oklahoma City Oklahoma
United States Universityof California, Irvine Orange California
United States Northwest Cancer Specialists P.C. (USO - US Oncology) Portland Oregon
United States Oregon Health and Science University Portland Oregon
United States Providence Portland Medical Center Portland Oregon
United States University of Utah, Huntsman Cancer Institute Salt Lake City Utah
United States Saint John's Health Center - John Wayne Cancer Institute (JWCI) Santa Monica California
United States Pinnacle Oncology, Honor Health Scottsdale Arizona
United States University of Washington / Seattle Cancer Care Alliance Seattle Washington
United States Stanford University School of Medicine Stanford California
United States Medstar Georgetown University Medical Center Washington District of Columbia

Sponsors (2)

Lead Sponsor Collaborator
zr Pharma & GmbH Foundation Medicine

Countries where clinical trial is conducted

United States,  France,  Germany,  Italy,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Progression-free Survival (PFS) According to RECIST v1.1, as Assessed by the Investigator 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. Cycle 1 Day 1 to End of Treatment, up to approximately 10 months
Secondary Overall Survival 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). The total study time for reporting of deaths was approximately 19 months.
Secondary Pharmacokinetics - Trough (Cmin) Level Rucaparib Concentrations 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. From Cycle 2 Day 1 to Cycle 4 Day 1, or approximately 2 months
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