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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03397394
Recruitment Status : Terminated (Efficacy did not meet the continuance criteria and DMC recommended to stop enrollment.)
First Posted : January 12, 2018
Results First Posted : October 19, 2020
Last Update Posted : October 19, 2020
Sponsor:
Collaborator:
Foundation Medicine
Information provided by (Responsible Party):
Clovis Oncology, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Bladder Cancer Urothelial Carcinoma Metastatic Urothelial Carcinoma Renal Pelvis Carcinoma Ureter Carcinoma Urinary Bladder Carcinoma Urethra Carcinoma Muscle Invasive Bladder Cancer Drug: Rucaparib Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 97 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Open-label Study of Rucaparib in Patients With Locally Advanced or Metastatic Urothelial Carcinoma
Actual Study Start Date : June 1, 2018
Actual Primary Completion Date : December 12, 2019
Actual Study Completion Date : January 15, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Rucaparib

Arms and Interventions
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Arm Intervention/treatment
Experimental: Rucaparib
Oral rucaparib (monotherapy)
 Drug: Rucaparib
Rucaparib will be administered daily.
Other Name: CO-338


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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).

  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03397394


Locations
Show Show 64 study locations
Sponsors and Collaborators
Clovis Oncology, Inc.
Foundation Medicine
  Study Documents (Full-Text)

Documents provided by Clovis Oncology, Inc.:
Study Protocol  [PDF] October 24, 2018
Statistical Analysis Plan  [PDF] January 31, 2018

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Clovis Oncology, Inc.
ClinicalTrials.gov Identifier: NCT03397394    
Other Study ID Numbers: CO-338-085
First Posted: January 12, 2018    Key Record Dates
Results First Posted: October 19, 2020
Last Update Posted: October 19, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Clovis Oncology, Inc.:
PARP inhibitor
PARPi
HRD
ATLAS
homologous recombination
DNA repair
 LOH
DNA defect
DNA anomaly
Rucaparib
MIBC
Additional relevant MeSH terms:
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Carcinoma
Urinary Bladder Neoplasms
Carcinoma, Transitional Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
 Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases
Rucaparib
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents