Clinical trial NCT03397394: Rucaparib in Patients With Locally Advanced or Metastatic Urothelial Carcinoma
Official title: A Phase 2, Open-label Study of Rucaparib in Patients With Locally Advanced or Metastatic Urothelial Carcinoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Bladder Cancer
Urothelial Carcinoma
Metastatic Urothelial Carcinoma
Renal Pelvis Carcinoma
Ureter Carcinoma
Urinary Bladder Carcinoma
Urethra Carcinoma
Muscle Invasive Bladder Cancer
Keywords: PARP inhibitor
PARPi
HRD
ATLAS
homologous recombination
DNA repair
LOH
DNA defect
DNA anomaly
Rucaparib
MIBC
Lead sponsor: pharmaand GmbH
Sponsor class: INDUSTRY
Collaborators: name: Foundation Medicine
First posted: 2018-01-12
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Objective Response Rate (ORR) Per RECIST Version 1.1
timeFrame: Time from first dose to date of progression, up to approximately 19 months
Secondary outcomes:
measure: Progression-free Survival (PFS) According to RECIST v1.1, as Assessed by the Investigator
timeFrame: Cycle 1 Day 1 to End of Treatment, up to approximately 10 months
measure: Overall Survival
timeFrame: The total study time for reporting of deaths was approximately 19 months.
measure: Pharmacokinetics - Trough (Cmin) Level Rucaparib Concentrations
timeFrame: From Cycle 2 Day 1 to Cycle 4 Day 1, or approximately 2 months
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Pinnacle Oncology, Honor Health
state: Arizona
city: La Jolla
country: United States
facility: University of California San Diego (UCSD), Moores Cancer Center
state: California
city: Los Angeles
country: United States
facility: University of California, Los Angeles (UCLA)
state: California
city: Orange
country: United States
facility: Universityof California, Irvine
state: California
city: Santa Monica
country: United States
facility: Saint John's Health Center - John Wayne Cancer Institute (JWCI)
state: California
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
city: Hartford
country: United States
facility: Hartford Health Care Cancer Institute
state: Connecticut
city: Norwich
country: United States
facility: Eastern Connecticut Hematology & Oncology Associates (ECHO)
state: Connecticut
city: Washington
country: United States
facility: Medstar Georgetown University Medical Center
state: District of Columbia
city: Miami
country: United States
facility: Miami Cancer Institute, Baptist Health South Florida
state: Florida
city: Chicago
country: United States
facility: Northwestern University, Chicago
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University - Melvin and Bren Simon Cancer Center (IUSCC)
state: Indiana
city: Iowa City
country: United States
facility: The University of Iowa and Holden Comprehensive Cancer Center
state: Iowa
city: Louisville
country: United States
facility: Norton Cancer Center
state: Kentucky
city: New Orleans
country: United States
facility: Ochsner Cancer Institute
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland, Marlene and Stewart Greenebaum Cancer Center
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Minneapolis
country: United States
facility: Minnesota Oncology Hematology P.A. (USO - US Oncology)
state: Minnesota
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada (CCCN)
state: Nevada
city: Hackensack
country: United States
facility: John Theurer Cancer Center at Hackensack University Medical Center
state: New Jersey
city: Albuquerque
country: United States
facility: University of New Mexico UNM Cancer Research and Treatment Center
state: New Mexico
city: Albany
country: United States
facility: New York Oncology Hematology, P.C. (USO - US Oncology)
state: New York
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: New York
country: United States
facility: New York - Presbyterian Hospital-Weill Cornell Medical Center
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Durham
country: United States
facility: Duke University, Duke Cancer Institute
state: North Carolina
city: Oklahoma City
country: United States
facility: Stephenson Cancer Center
state: Oklahoma
city: Portland
country: United States
facility: Northwest Cancer Specialists P.C. (USO - US Oncology)
state: Oregon
city: Portland
country: United States
facility: Providence Portland Medical Center
state: Oregon
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Allentown
country: United States
facility: Lehigh Valley Health Network
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State Hershey Medical Center
state: Pennsylvania
city: Myrtle Beach
country: United States
facility: Atlantic Urology Clinics
state: South Carolina
city: Chattanooga
country: United States
facility: University Oncology & Hematology
state: Tennessee
city: Nashville
country: United States
facility: Urology Associates
state: Tennessee
city: Dallas
country: United States
facility: Texas Oncology PA (USO - US Oncology)
state: Texas
city: Houston
country: United States
facility: University of Texas, UT Health Science Center
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah, Huntsman Cancer Institute
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia, Emily Couric Clinical Center
state: Virginia
city: Seattle
country: United States
facility: University of Washington / Seattle Cancer Care Alliance
state: Washington
city: Milwaukee
country: United States
facility: Froedtert & Medical College of Wisconsin
state: Wisconsin
city: Lyon
country: France
facility: Centre de Lutte Contre le Cancer (CLCC) - Universite de Lyon - Centre Leon-Berard
city: Paris
country: France
facility: Hopital Saint-Louis
city: Saint-Herblain
country: France
facility: Centre de Lutte Contre le Cancer - Institut de Cancerologie de l'Ouest - Rene Gauducheau
city: Toulouse
country: France
facility: Institut Universitaire du Cancer de Toulouse - Oncopole
city: Villejuif
country: France
facility: Institut Gustave Roussy
city: Erlangen
country: Germany
facility: Urologische und Kinderurologische Universitätsklinik im Malteser
city: Münster
country: Germany
facility: Universitatsklinikum Munster / Urologie und Kinderurologie
city: Nurtingen
country: Germany
facility: Studienpraxis Urologie
city: Candiolo
country: Italy
facility: Fondazionerca sul Cancro ONLUS - Istituto di Candiolo IRCCS
city: Milano
country: Italy
facility: IRCCS Ospedale San Raffaele - Medical Oncology Dept
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale Tumori
city: Naples
country: Italy
facility: Azienda Ospedaliera Universitaria Federico II Oncologia Medica
city: Pamplona
country: Spain
facility: Universidad de Navarra - Clinica Universitaria de Navarra
state: Navarre
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron de Barcelona
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon
city: Madrid
country: Spain
facility: Clinica Universitaria de Navarra Madrid
city: Madrid
country: Spain
facility: MD Anderson Cancer Center
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Santiago De Compostela
country: Spain
facility: Hospital Clínico Universitario de Santiago de Compostela
city: London
country: United Kingdom
facility: Sarah Cannon Research Institute - United Kingdom - London Office
city: London
country: United Kingdom
facility: Guy's & St. Thomas' Hospital (London Oncology Clinic)
Study officials:
References:
citation: 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.