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

June 7, 2023 updated by: zr Pharma & GmbH

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

The purpose of the ATLAS study is to determine how patients with locally advanced unresectable or metastatic urothelial carcinoma respond to treatment with rucaparib.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
97

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France, 69008
        • Centre de Lutte Contre le Cancer (CLCC) - Universite de Lyon - Centre Leon-Berard
      • Paris, France, 75010
        • Hôpital Saint-Louis
      • Saint-Herblain, France, 44805
        • Centre de Lutte Contre Le Cancer - Institut de Cancerologie de L'Ouest - Rene Gauducheau
      • Toulouse, France, 31059
        • Institut Universitaire du Cancer de Toulouse - Oncopole
      • Villejuif, France, 94805
        • Institut Gustave Roussy
  • Germany
      • Erlangen, Germany, 91054
        • Urologische und Kinderurologische Universitätsklinik im Malteser
      • Münster, Germany, 26133
        • Universitatsklinikum Munster / Urologie und Kinderurologie
      • Nurtingen, Germany, 72622
        • Studienpraxis Urologie
  • Italy
      • Candiolo, Italy, 10060
        • Fondazionerca sul Cancro ONLUS - Istituto di Candiolo IRCCS
      • Milano, Italy, 20133
        • Fondazione IRCCS Istituto Nazionale Tumori
      • Milano, Italy, 20132
        • IRCCS Ospedale San Raffaele - Medical Oncology Dept
      • Naples, Italy, 80131
        • Azienda Ospedaliera Universitaria Federico II Oncologia Medica
  • Spain
      • Barcelona, Spain, 08003
        • Hospital del Mar
      • Barcelona, Spain, 08025
        • Hospital Santa Creu i Sant Pau
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron de Barcelona
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Marañón
      • Madrid, Spain, 28033
        • MD Anderson Cancer Center
      • Madrid, Spain, 28027
        • Clinica Universitaria de Navarra Madrid
      • Santiago De Compostela, Spain, 15706
        • Hospital Clinico Universitario de Santiago de Compostela
    • Navarre
      • Pamplona, Navarre, Spain, 31008
        • Universidad de Navarra - Clinica Universitaria de Navarra
  • United Kingdom
      • London, United Kingdom, CH63 4JY
        • Sarah Cannon Research Institute - United Kingdom - London Office
      • London, United Kingdom, W1G 6AF
        • Guy's & St. Thomas' Hospital (London Oncology Clinic)
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • Pinnacle Oncology, Honor Health
    • California
      • La Jolla, California, United States, 92093
        • University of California San Diego (UCSD), Moores Cancer Center
      • Los Angeles, California, United States, 90095
        • University of California, Los Angeles (UCLA)
      • Orange, California, United States, 92868
        • Universityof California, Irvine
      • Santa Monica, California, United States, 90404
        • Saint John's Health Center - John Wayne Cancer Institute (JWCI)
      • Stanford, California, United States, 94304
        • Stanford University School of Medicine
    • Connecticut
      • Hartford, Connecticut, United States, 06102
        • Hartford Health Care Cancer Institute
      • Norwich, Connecticut, United States, 06360
        • Eastern Connecticut Hematology & Oncology Associates (ECHO)
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • MedStar Georgetown University Medical Center
    • Florida
      • Miami, Florida, United States, 33176
        • Miami Cancer Institute, Baptist Health South Florida
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University, Chicago
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University - Melvin and Bren Simon Cancer Center (IUSCC)
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • The University of Iowa and Holden Comprehensive Cancer Center
    • Kentucky
      • Louisville, Kentucky, United States, 40207
        • Norton Cancer Center
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Cancer Institute
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland, Marlene and Stewart Greenebaum Cancer Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Minnesota Oncology Hematology P.A. (USO - US Oncology)
    • Nevada
      • Las Vegas, Nevada, United States, 89169
        • Comprehensive Cancer Centers of Nevada (CCCN)
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • John Theurer Cancer Center at Hackensack University Medical Center
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • University of New Mexico UNM Cancer Research and Treatment Center
    • New York
      • Albany, New York, United States, 12208
        • New York Oncology Hematology, P.C. (USO - US Oncology)
      • Buffalo, New York, United States, 14263
        • Roswell Park Cancer Institute
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
      • New York, New York, United States, 10021
        • New York - Presbyterian Hospital-Weill Cornell Medical Center
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University, Duke Cancer Institute
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Stephenson Cancer Center
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University
      • Portland, Oregon, United States, 97213
        • Providence Portland Medical Center
      • Portland, Oregon, United States, 97062
        • Northwest Cancer Specialists P.C. (USO - US Oncology)
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Lehigh Valley Health Network
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Hershey Medical Center
    • South Carolina
      • Myrtle Beach, South Carolina, United States, 29572
        • Atlantic Urology Clinics
    • Tennessee
      • Chattanooga, Tennessee, United States, 37403
        • University Oncology & Hematology
      • Nashville, Tennessee, United States, 37209
        • Urology Associates
    • Texas
      • Dallas, Texas, United States, 76201
        • Texas Oncology PA (USO - US Oncology)
      • Houston, Texas, United States, 77030
        • University of Texas, UT Health Science Center
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • University of Utah, Huntsman Cancer Institute
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia, Emily Couric Clinical Center
    • Washington
      • Seattle, Washington, United States, 98109
        • University of Washington / Seattle Cancer Care Alliance
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Froedtert & Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Rucaparib
Oral rucaparib (monotherapy)
Drug: Rucaparib
Rucaparib will be administered daily.
Other Names:
  • CO-338

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR) Per RECIST Version 1.1
Time Frame: 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.
Time from first dose to date of progression, up to approximately 19 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Progression-free Survival (PFS) According to RECIST v1.1, as Assessed by the Investigator
Time Frame: 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.
Cycle 1 Day 1 to End of Treatment, up to approximately 10 months
Overall Survival
Time Frame: 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).
The total study time for reporting of deaths was approximately 19 months.
Pharmacokinetics - Trough (Cmin) Level Rucaparib Concentrations
Time Frame: 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.
From Cycle 2 Day 1 to Cycle 4 Day 1, or approximately 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
zr Pharma & GmbH

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Foundation Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 12, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 15, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 21, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 12, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 9, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 7, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CO-338-085
  • 2017-004166-10 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Bladder Cancer

Clinical Trials on Rucaparib

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings