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A Study to Evaluate Rucaparib in Patients With Solid Tumors and With Deleterious Mutations in HRR Genes (LODESTAR)

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ClinicalTrials.gov Identifier: NCT04171700
Recruitment Status : Active, not recruiting
First Posted : November 21, 2019
Last Update Posted : March 28, 2022
Sponsor:
Information provided by (Responsible Party):
Clovis Oncology, Inc.

Study Description
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Brief Summary:
A Phase 2, open-label, single-arm trial to evaluate the response of rucaparib in patients with various solid tumors and with deleterious mutations in Homologous Recombination Repair (HRR) genes.

Condition or disease Intervention/treatment Phase
Solid Tumor Drug: Rucaparib Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Multicenter, Open-label Study of Rucaparib as Treatment for Solid Tumors Associated With Deleterious Mutations in Homologous Recombination Repair Genes
Actual Study Start Date : November 21, 2019
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : June 2022

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

Eligible patients will be enrolled in either Cohort A or Cohort B.

Cohort A: Up to 200 patients with deleterious mutations in BRCA1, BRCA2, PALB2, RAD51C or RAD51D.

Cohort B (Exploratory): Up to 20 patients with deleterious mutations in BARD1, BRIP1, FANCA, NBN, RAD51 or RAD51B.

 Drug: Rucaparib
Oral rucaparib will be administered twice daily. The starting dose will be 600 mg daily (BID).
Other Names:
  • Rubraca
  • Rucaparib camsylate
  • Rucaparib tablets
  • CO-338
  • PF 01367338
  • AG 014447


Outcome Measures
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Primary Outcome Measures :
  1. Best Overall Response Rate by Investigator [ Time Frame: From first dose of study drug until disease progression (up to approximately 2 years) ]
    Best overall response rate as assessed by the investigator by RECIST v1.1 (or by RECIST v1.1 and PCWG3 in patients with advanced prostate cancer).


Secondary Outcome Measures :
  1. Overall Response Rate by Independent Radiology Review [ Time Frame: From first dose of study drug until disease progression (up to approximately 2 years) ]
    Best overall response rate by independent radiology review by RECIST v1.1 (or by RECIST v1.1 and PCWG3 in patients with advanced prostate cancer)

  2. Duration of Response [ Time Frame: From first dose of study drug until disease progression (up to approximately 2 years) ]
    Measure of clinical benefit, defined as the time from initial tumor response to documented tumor progression.

  3. Disease Control Rate [ Time Frame: From first dose of study drug until disease progression (up to approximately 2 years) ]
    Measure of clinical benefit, defined as the percentage of complete response (CR), partial response (PR), and stable disease (SD) beyond 16 weeks.

  4. Progression-Free Survival [ Time Frame: From first dose of study drug until disease progression (up to approximately 2 years) ]
    Measure of clinical benefit, defined as the duration from study enrollment to objective tumor progression.

  5. Overall Survival [ Time Frame: From first dose of study drug until disease progression (up to approximately 2 years) ]
    Measure of clinical benefit, defined as the duration from study enrollment to death.

  6. Safety and Tolerability of rucaparib [ Time Frame: From first dose of study drug until disease progression (up to approximately 2 years) ]
    Incidence of AEs, clinical lab abnormalities, and dose modifications.

  7. Steady state minimum concentration [Cmin] [ Time Frame: From first dose of study drug until disease progression (up to approximately 2 years) ]
    Rucaparib PK


Eligibility Criteria
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Information from the National Library of Medicine

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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

Key Inclusion Criteria:

  • Unresectable, locally advanced or metastatic solid tumor and relapsed/progressive disease
  • Measurable disease per RECIST v1.1 or modified RECIST v1.1 and PCWG3 (for prostate cancer)
  • Have a deleterious mutation (germline or somatic) in BRCA1, BRCA2, PALB2, RAD51C, RAD51D, BARD1, BRIP1, FANCA, NBN, RAD51 or RAD51B. Note: Breast cancer patients that are HER2 negative and have germline BRCA1 or BRCA2 mutations AND patients with epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer or metastatic castration-resistant prostate cancer with BRCA1 or BRCA2 mutations are ineligible for this trial.
  • At least one prior line of therapy extending overall survival or standard of care therapy for advanced disease. Note: Some tumor types have specific inclusion/exclusion criteria for previous treatments.
  • ECOG 0 or 1
  • Tumor tissue available for genomic analysis, or must be willing to have a biopsy if no archival tumor tissue available
  • Adequate organ function
  • Life expectancy of 4 months

Key Exclusion Criteria:

  • Active central nervous system brain metastases, leptomeningeal disease or primary tumor of CNS origin
  • Active second malignancy (Exceptions: Successfully treated malignancy with no active disease for 1 year, surgically cured and/or low-risk tumors, or patients receiving ongoing anticancer hormonal therapy for a previously treated cancer)
  • Pre-existing gastrointestinal disorders/conditions interfering with ingestion/absorption of rucaparib
  • Prior treatment with a PARP inhibitor
  • More than 3 prior lines of chemotherapy in the locally advanced/metastatic setting
  • History of myelodysplastic syndrome or acute myeloid leukemia
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): NCT04171700


Locations
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Sponsors and Collaborators
Clovis Oncology, Inc.
Investigators
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Principal Investigator: Kim Reiss-Binder, MD University of Pennsylvania
More Information
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Responsible Party: Clovis Oncology, Inc.
ClinicalTrials.gov Identifier: NCT04171700    
Other Study ID Numbers: CO-338-100
First Posted: November 21, 2019    Key Record Dates
Last Update Posted: March 28, 2022
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

De-identified datasets for study results will be made available to qualified researchers in compliance with applicable privacy laws and data protection regulations.

Data will be provided by Clovis Oncology.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Data will be made available to qualified researchers after the primary, secondary, and/or exploratory outcomes of the study are reported or published and for 1 year thereafter.
Access Criteria: Requests for de-identified datasets will be made available to qualified researchers following submission of a methodologically sound proposal to medinfo@clovisoncology.com.

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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.:
rucaparib
PARPi
rare tumor
solid tumor
CO-338
ovarian cancer
prostate cancer
pancreatic cancer
breast cancer
lung cancer
colon cancer
gastric cancer
bladder cancer
colorectal cancer
PARP inhibitor
 homologous recombination
DNA repair
LODESTAR
germline
somatic
BRCA1
BRCA2
PALB2
RAD51C
RAD51D
BARD1
BRIP1
FANCA
RAD51
RAD51B
Additional relevant MeSH terms:
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Neoplasms
Rucaparib
Poly(ADP-ribose) Polymerase Inhibitors
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents