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Rucaparib in Patients With Locally Advanced or Metastatic Urothelial Carcinoma (ATLAS)

Primary Purpose

Bladder Cancer, Urothelial Carcinoma, Metastatic Urothelial Carcinoma

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Rucaparib
Sponsored by
pharmaand GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bladder Cancer focused on measuring PARP inhibitor, PARPi, HRD, ATLAS, homologous recombination, DNA repair, LOH, DNA defect, DNA anomaly, Rucaparib, MIBC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pinnacle Oncology, Honor Health
  • University of California San Diego (UCSD), Moores Cancer Center
  • University of California, Los Angeles (UCLA)
  • Universityof California, Irvine
  • Saint John's Health Center - John Wayne Cancer Institute (JWCI)
  • Stanford University School of Medicine
  • Hartford Health Care Cancer Institute
  • Eastern Connecticut Hematology & Oncology Associates (ECHO)
  • Medstar Georgetown University Medical Center
  • Miami Cancer Institute, Baptist Health South Florida
  • Northwestern University, Chicago
  • Indiana University - Melvin and Bren Simon Cancer Center (IUSCC)
  • The University of Iowa and Holden Comprehensive Cancer Center
  • Norton Cancer Center
  • Ochsner Cancer Institute
  • University of Maryland, Marlene and Stewart Greenebaum Cancer Center
  • University of Michigan
  • Minnesota Oncology Hematology P.A. (USO - US Oncology)
  • Comprehensive Cancer Centers of Nevada (CCCN)
  • John Theurer Cancer Center at Hackensack University Medical Center
  • University of New Mexico UNM Cancer Research and Treatment Center
  • New York Oncology Hematology, P.C. (USO - US Oncology)
  • Roswell Park Cancer Institute
  • New York - Presbyterian Hospital-Weill Cornell Medical Center
  • Memorial Sloan Kettering Cancer Center
  • Duke University, Duke Cancer Institute
  • Stephenson Cancer Center
  • Northwest Cancer Specialists P.C. (USO - US Oncology)
  • Providence Portland Medical Center
  • Oregon Health and Science University
  • Lehigh Valley Health Network
  • Penn State Hershey Medical Center
  • Atlantic Urology Clinics
  • University Oncology & Hematology
  • Urology Associates
  • Texas Oncology PA (USO - US Oncology)
  • University of Texas, UT Health Science Center
  • University of Utah, Huntsman Cancer Institute
  • University of Virginia, Emily Couric Clinical Center
  • University of Washington / Seattle Cancer Care Alliance
  • Froedtert & Medical College of Wisconsin
  • Centre de Lutte Contre le Cancer (CLCC) - Universite de Lyon - Centre Leon-Berard
  • Hopital Saint-Louis
  • Centre de Lutte Contre le Cancer - Institut de Cancerologie de l'Ouest - Rene Gauducheau
  • Institut Universitaire du Cancer de Toulouse - Oncopole
  • Institut Gustave Roussy
  • Urologische und Kinderurologische Universitätsklinik im Malteser
  • Universitatsklinikum Munster / Urologie und Kinderurologie
  • Studienpraxis Urologie
  • Fondazionerca sul Cancro ONLUS - Istituto di Candiolo IRCCS
  • IRCCS Ospedale San Raffaele - Medical Oncology Dept
  • Fondazione IRCCS Istituto Nazionale Tumori
  • Azienda Ospedaliera Universitaria Federico II Oncologia Medica
  • Universidad de Navarra - Clinica Universitaria de Navarra
  • Hospital del Mar
  • Hospital Santa Creu i Sant Pau
  • Hospital Universitari Vall d'Hebron de Barcelona
  • Hospital General Universitario Gregorio Maranon
  • Clinica Universitaria de Navarra Madrid
  • MD Anderson Cancer Center
  • Hospital Universitario 12 de Octubre
  • Hospital Clínico Universitario de Santiago de Compostela
  • Sarah Cannon Research Institute - United Kingdom - London Office
  • Guy's & St. Thomas' Hospital (London Oncology Clinic)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Rucaparib

Arm Description

Oral rucaparib (monotherapy)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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).
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.

Full Information

First Posted
December 21, 2017
Last Updated
June 7, 2023
Sponsor
pharmaand GmbH
Collaborators
Foundation Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT03397394
Brief Title
Rucaparib in Patients With Locally Advanced or Metastatic Urothelial Carcinoma
Acronym
ATLAS
Official Title
A Phase 2, Open-label Study of Rucaparib in Patients With Locally Advanced or Metastatic Urothelial Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Terminated
Why Stopped
Efficacy did not meet the continuance criteria and DMC recommended to stop enrollment.
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
December 12, 2019 (Actual)
Study Completion Date
January 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
pharmaand GmbH
Collaborators
Foundation Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
97 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rucaparib
Arm Type
Experimental
Arm Description
Oral rucaparib (monotherapy)
Intervention Type
Drug
Intervention Name(s)
Rucaparib
Other Intervention Name(s)
CO-338
Intervention Description
Rucaparib will be administered daily.
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR) Per RECIST Version 1.1
Description
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 Frame
Time from first dose to date of progression, up to approximately 19 months
Secondary Outcome Measure Information:
Title
Progression-free Survival (PFS) According to RECIST v1.1, as Assessed by the Investigator
Description
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.
Time Frame
Cycle 1 Day 1 to End of Treatment, up to approximately 10 months
Title
Overall Survival
Description
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).
Time Frame
The total study time for reporting of deaths was approximately 19 months.
Title
Pharmacokinetics - Trough (Cmin) Level Rucaparib Concentrations
Description
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.
Time Frame
From Cycle 2 Day 1 to Cycle 4 Day 1, or approximately 2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Pinnacle Oncology, Honor Health
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
University of California San Diego (UCSD), Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
University of California, Los Angeles (UCLA)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Universityof California, Irvine
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Saint John's Health Center - John Wayne Cancer Institute (JWCI)
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Hartford Health Care Cancer Institute
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102
Country
United States
Facility Name
Eastern Connecticut Hematology & Oncology Associates (ECHO)
City
Norwich
State/Province
Connecticut
ZIP/Postal Code
06360
Country
United States
Facility Name
Medstar Georgetown University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Miami Cancer Institute, Baptist Health South Florida
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Northwestern University, Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Indiana University - Melvin and Bren Simon Cancer Center (IUSCC)
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
The University of Iowa and Holden Comprehensive Cancer Center
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Norton Cancer Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
Ochsner Cancer Institute
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
University of Maryland, Marlene and Stewart Greenebaum Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Minnesota Oncology Hematology P.A. (USO - US Oncology)
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada (CCCN)
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
Facility Name
John Theurer Cancer Center at Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
University of New Mexico UNM Cancer Research and Treatment Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
New York Oncology Hematology, P.C. (USO - US Oncology)
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
New York - Presbyterian Hospital-Weill Cornell Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Duke University, Duke Cancer Institute
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Stephenson Cancer Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Northwest Cancer Specialists P.C. (USO - US Oncology)
City
Portland
State/Province
Oregon
ZIP/Postal Code
97062
Country
United States
Facility Name
Providence Portland Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Lehigh Valley Health Network
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Penn State Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Atlantic Urology Clinics
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Facility Name
University Oncology & Hematology
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States
Facility Name
Urology Associates
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37209
Country
United States
Facility Name
Texas Oncology PA (USO - US Oncology)
City
Dallas
State/Province
Texas
ZIP/Postal Code
76201
Country
United States
Facility Name
University of Texas, UT Health Science Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Utah, Huntsman Cancer Institute
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
University of Virginia, Emily Couric Clinical Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
University of Washington / Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Froedtert & Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Centre de Lutte Contre le Cancer (CLCC) - Universite de Lyon - Centre Leon-Berard
City
Lyon
ZIP/Postal Code
69008
Country
France
Facility Name
Hopital Saint-Louis
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Centre de Lutte Contre le Cancer - Institut de Cancerologie de l'Ouest - Rene Gauducheau
City
Saint-Herblain
ZIP/Postal Code
44805
Country
France
Facility Name
Institut Universitaire du Cancer de Toulouse - Oncopole
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France
Facility Name
Urologische und Kinderurologische Universitätsklinik im Malteser
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Universitatsklinikum Munster / Urologie und Kinderurologie
City
Münster
ZIP/Postal Code
26133
Country
Germany
Facility Name
Studienpraxis Urologie
City
Nurtingen
ZIP/Postal Code
72622
Country
Germany
Facility Name
Fondazionerca sul Cancro ONLUS - Istituto di Candiolo IRCCS
City
Candiolo
ZIP/Postal Code
10060
Country
Italy
Facility Name
IRCCS Ospedale San Raffaele - Medical Oncology Dept
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Fondazione IRCCS Istituto Nazionale Tumori
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Federico II Oncologia Medica
City
Naples
ZIP/Postal Code
80131
Country
Italy
Facility Name
Universidad de Navarra - Clinica Universitaria de Navarra
City
Pamplona
State/Province
Navarre
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron de Barcelona
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital General Universitario Gregorio Maranon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Clinica Universitaria de Navarra Madrid
City
Madrid
ZIP/Postal Code
28027
Country
Spain
Facility Name
MD Anderson Cancer Center
City
Madrid
ZIP/Postal Code
28033
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Clínico Universitario de Santiago de Compostela
City
Santiago De Compostela
ZIP/Postal Code
15706
Country
Spain
Facility Name
Sarah Cannon Research Institute - United Kingdom - London Office
City
London
ZIP/Postal Code
CH63 4JY
Country
United Kingdom
Facility Name
Guy's & St. Thomas' Hospital (London Oncology Clinic)
City
London
ZIP/Postal Code
W1G 6AF
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
34030643
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.
Results Reference
derived

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Rucaparib in Patients With Locally Advanced or Metastatic Urothelial Carcinoma

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