Rucaparib in Patients With Locally Advanced or Metastatic Urothelial Carcinoma

Phase 2

Terminated

Conditions: Bladder Cancer
Metastatic Urothelial Carcinoma
Ureter Carcinoma
Muscle Invasive Bladder Cancer
Urothelial Carcinoma
Urinary Bladder Carcinoma
Renal Pelvis Carcinoma
Urethra Carcinoma

Interventions: Drug: Rucaparib

Registration Number: NCT03397394

Lead Sponsor: pharmaand GmbH

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 97

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

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Rucaparib	Rucaparib	Oral rucaparib (monotherapy)

Primary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR) Per RECIST Version 1.1	Time from first dose to date of progression, up to approximately 19 months	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.

Secondary Outcome Measures

Name	Time	Method
Overall Survival	The total study time for reporting of deaths was approximately 19 months.	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).
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	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.
Pharmacokinetics - Trough (Cmin) Level Rucaparib Concentrations	From Cycle 2 Day 1 to Cycle 4 Day 1, or approximately 2 months	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.

Trial Locations

Locations (64): University of Maryland, Marlene and Stewart Greenebaum Cancer Center
🇺🇸
Baltimore, Maryland, United States
Northwestern University, Chicago
🇺🇸
Chicago, Illinois, United States
Miami Cancer Institute, Baptist Health South Florida
🇺🇸
Miami, Florida, United States
Minnesota Oncology Hematology P.A. (USO - US Oncology)
🇺🇸
Minneapolis, Minnesota, United States
Comprehensive Cancer Centers of Nevada (CCCN)
🇺🇸
Las Vegas, Nevada, United States
Stephenson Cancer Center
🇺🇸
Oklahoma City, Oklahoma, United States
Urology Associates
🇺🇸
Nashville, Tennessee, United States
University of Texas, UT Health Science Center
🇺🇸
Houston, Texas, United States
University of Utah, Huntsman Cancer Institute
🇺🇸
Salt Lake City, Utah, United States
University of Washington / Seattle Cancer Care Alliance
🇺🇸
Seattle, Washington, United States
Azienda Ospedaliera Universitaria Federico II Oncologia Medica
🇮🇹
Naples, Italy
Duke University, Duke Cancer Institute
🇺🇸
Durham, North Carolina, United States
Memorial Sloan Kettering Cancer Center
🇺🇸
New York, New York, United States
Lehigh Valley Health Network
🇺🇸
Allentown, Pennsylvania, United States
Indiana University - Melvin and Bren Simon Cancer Center (IUSCC)
🇺🇸
Indianapolis, Indiana, United States
Atlantic Urology Clinics
🇺🇸
Myrtle Beach, South Carolina, United States
Pinnacle Oncology, Honor Health
🇺🇸
Scottsdale, Arizona, United States
University Oncology & Hematology
🇺🇸
Chattanooga, Tennessee, United States
IRCCS Ospedale San Raffaele - Medical Oncology Dept
🇮🇹
Milano, Italy
University of Virginia, Emily Couric Clinical Center
🇺🇸
Charlottesville, Virginia, United States
Hopital Saint-Louis
🇫🇷
Paris, France
Centre de Lutte Contre le Cancer (CLCC) - Universite de Lyon - Centre Leon-Berard
🇫🇷
Lyon, France
Sarah Cannon Research Institute - United Kingdom - London Office
🇬🇧
London, United Kingdom
Institut Universitaire du Cancer de Toulouse - Oncopole
🇫🇷
Toulouse, France
Hospital Clínico Universitario de Santiago de Compostela
🇪🇸
Santiago De Compostela, Spain
Urologische und Kinderurologische Universitätsklinik im Malteser
🇩🇪
Erlangen, Germany
University of California, Los Angeles (UCLA)
🇺🇸
Los Angeles, California, United States
Stanford University School of Medicine
🇺🇸
Stanford, California, United States
Saint John's Health Center - John Wayne Cancer Institute (JWCI)
🇺🇸
Santa Monica, California, United States
University of California San Diego (UCSD), Moores Cancer Center
🇺🇸
La Jolla, California, United States
Eastern Connecticut Hematology & Oncology Associates (ECHO)
🇺🇸
Norwich, Connecticut, United States
Universityof California, Irvine
🇺🇸
Orange, California, United States
Medstar Georgetown University Medical Center
🇺🇸
Washington, District of Columbia, United States
The University of Iowa and Holden Comprehensive Cancer Center
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Iowa City, Iowa, United States
University of New Mexico UNM Cancer Research and Treatment Center
🇺🇸
Albuquerque, New Mexico, United States
New York Oncology Hematology, P.C. (USO - US Oncology)
🇺🇸
Albany, New York, United States
New York - Presbyterian Hospital-Weill Cornell Medical Center
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New York, New York, United States
Texas Oncology PA (USO - US Oncology)
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Dallas, Texas, United States
Studienpraxis Urologie
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Nurtingen, Germany
Centre de Lutte Contre le Cancer - Institut de Cancerologie de l'Ouest - Rene Gauducheau
🇫🇷
Saint-Herblain, France
Universitatsklinikum Munster / Urologie und Kinderurologie
🇩🇪
Münster, Germany
Institut Gustave Roussy
🇫🇷
Villejuif, France
Fondazionerca sul Cancro ONLUS - Istituto di Candiolo IRCCS
🇮🇹
Candiolo, Italy
Universidad de Navarra - Clinica Universitaria de Navarra
🇪🇸
Pamplona, Navarre, Spain
Hospital General Universitario Gregorio Maranon
🇪🇸
Madrid, Spain
Clinica Universitaria de Navarra Madrid
🇪🇸
Madrid, Spain
Hospital del Mar
🇪🇸
Barcelona, Spain
Hospital Universitari Vall d'Hebron de Barcelona
🇪🇸
Barcelona, Spain
Fondazione IRCCS Istituto Nazionale Tumori
🇮🇹
Milano, Italy
Hospital Santa Creu i Sant Pau
🇪🇸
Barcelona, Spain
MD Anderson Cancer Center
🇪🇸
Madrid, Spain
Hospital Universitario 12 de Octubre
🇪🇸
Madrid, Spain
Guy's & St. Thomas' Hospital (London Oncology Clinic)
🇬🇧
London, United Kingdom
Hartford Health Care Cancer Institute
🇺🇸
Hartford, Connecticut, United States
John Theurer Cancer Center at Hackensack University Medical Center
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Hackensack, New Jersey, United States
Roswell Park Cancer Institute
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Buffalo, New York, United States
Norton Cancer Center
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Louisville, Kentucky, United States
Ochsner Cancer Institute
🇺🇸
New Orleans, Louisiana, United States
Northwest Cancer Specialists P.C. (USO - US Oncology)
🇺🇸
Portland, Oregon, United States
Oregon Health and Science University
🇺🇸
Portland, Oregon, United States
Froedtert & Medical College of Wisconsin
🇺🇸
Milwaukee, Wisconsin, United States
University of Michigan
🇺🇸
Ann Arbor, Michigan, United States
Providence Portland Medical Center
🇺🇸
Portland, Oregon, United States
Penn State Hershey Medical Center
🇺🇸
Hershey, Pennsylvania, United States