Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    rucaparib LODESTAR
Previous Study | Return to List | Next Study

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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04171700
Recruitment Status : Recruiting
First Posted : November 21, 2019
Last Update Posted : March 26, 2021
Sponsor:
Information provided by (Responsible Party):
Clovis Oncology, Inc.

Tracking Information
First Submitted Date  ICMJE November 19, 2019
First Posted Date  ICMJE November 21, 2019
Last Update Posted Date March 26, 2021
Actual Study Start Date  ICMJE November 21, 2019
Estimated Primary Completion Date November 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 19, 2019)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 19, 2019)
  • 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)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Steady state minimum concentration [Cmin] [ Time Frame: From first dose of study drug until disease progression (up to approximately 2 years) ]
    Rucaparib PK
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate Rucaparib in Patients With Solid Tumors and With Deleterious Mutations in HRR Genes
Official Title  ICMJE A Phase 2 Multicenter, Open-label Study of Rucaparib as Treatment for Solid Tumors Associated With Deleterious Mutations in Homologous Recombination Repair Genes
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Solid Tumor
Intervention  ICMJE 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
Study Arms  ICMJE 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.

Intervention: Drug: Rucaparib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 19, 2019)
220
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2022
Estimated Primary Completion Date November 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Clovis Oncology For North America, Latin America and Asia Pacific inquiries: 1-415-409-7220, 1-844-258-7662 medinfo@clovisoncology.com
Contact: Clovis Oncology For Europe and Rest of World related inquiries: +353 16950030 (toll-paid) MedInfo.IE@clovisoncology.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04171700
Other Study ID Numbers  ICMJE CO-338-100
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Clovis Oncology, Inc.
Study Sponsor  ICMJE Clovis Oncology, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kim Reiss-Binder, MD University of Pennsylvania
PRS Account Clovis Oncology, Inc.
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP