Clinical Trials /

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

NCT04171700

Description:

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.

Related Conditions:
  • Breast Carcinoma
  • Fallopian Tube Carcinoma
  • Malignant Solid Tumor
  • Ovarian Carcinoma
  • Primary Peritoneal Carcinoma
  • Prostate Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study to Evaluate Rucaparib in Patients With Solid Tumors and With Deleterious Mutations in HRR Genes
  • 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

Clinical Trial IDs

  • ORG STUDY ID: CO-338-100
  • NCT ID: NCT04171700

Conditions

  • Solid Tumor

Interventions

DrugSynonymsArms
RucaparibRubraca, Rucaparib camsylate, Rucaparib tablets, CO-338, PF 01367338, AG 014447Rucaparib

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
RucaparibExperimentalEligible 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.
  • Rucaparib

Eligibility 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

          -  3 or more prior lines of chemotherapy in the locally advanced/metastatic setting

          -  History of myelodysplastic syndrome or acute myeloid leukemia
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Best Overall Response Rate by Investigator
Time Frame:From first dose of study drug until disease progression (up to approximately 2 years)
Safety Issue:
Description: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

Measure:Overall Response Rate by Independent Radiology Review
Time Frame:From first dose of study drug until disease progression (up to approximately 2 years)
Safety Issue:
Description: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)
Measure:Duration of Response
Time Frame:From first dose of study drug until disease progression (up to approximately 2 years)
Safety Issue:
Description:Measure of clinical benefit, defined as the time from initial tumor response to documented tumor progression.
Measure:Disease Control Rate
Time Frame:From first dose of study drug until disease progression (up to approximately 2 years)
Safety Issue:
Description:Measure of clinical benefit, defined as the percentage of complete response (CR), partial response (PR), and stable disease (SD) beyond 16 weeks.
Measure:Progression-Free Survival
Time Frame:From first dose of study drug until disease progression (up to approximately 2 years)
Safety Issue:
Description:Measure of clinical benefit, defined as the duration from study enrollment to objective tumor progression.
Measure:Overall Survival
Time Frame:From first dose of study drug until disease progression (up to approximately 2 years)
Safety Issue:
Description:Measure of clinical benefit, defined as the duration from study enrollment to death.
Measure:Safety and Tolerability of rucaparib
Time Frame:From first dose of study drug until disease progression (up to approximately 2 years)
Safety Issue:
Description:Incidence of AEs, clinical lab abnormalities, and dose modifications.
Measure:Steady state minimum concentration [Cmin]
Time Frame:From first dose of study drug until disease progression (up to approximately 2 years)
Safety Issue:
Description:Rucaparib PK

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Clovis Oncology, Inc.

Trial Keywords

  • 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
  • sarcoma
  • HRR
  • HRD
  • platinum sensitive
  • platinum resistant
  • primary peritoneal cancer
  • fallopian tube cancer
  • tumor agnostic
  • basket study
  • basket trial
  • metastatic
  • locally advanced
  • esophageal cancer
  • leiomyosarcoma
  • ampullary carcinoma
  • carcinosarcoma
  • endometrial cancer
  • cervical cancer

Last Updated

December 18, 2019