Rucaparib in Patients With Locally Advanced or Metastatic Urothelial Carcinoma

Bladder Cancer Clinical Trial

— ATLAS  

Official title:

A Phase 2, Open-label Study of Rucaparib in Patients With Locally Advanced or Metastatic Urothelial Carcinoma

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
• 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
• 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

Related Conditions & MeSH terms

• Bladder Cancer
• Carcinoma
• Carcinoma, Transitional Cell
• Metastatic Urothelial Carcinoma
• Muscle Invasive Bladder Cancer
• Renal Pelvis Carcinoma
• Ureter Carcinoma
• Urethra Carcinoma
• Urinary Bladder Carcinoma
• Urinary Bladder Neoplasms
• Urothelial Carcinoma

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