A Phase 2 Multicenter, Open-label Study of Rucaparib as Treatment for Solid Tumors Associated With Deleterious Mutations in Homologous Recombination Repair Genes

pharmaand GmbH18 sites in 1 country83 target enrollmentJanuary 16, 2020

ConditionsSolid Tumor

InterventionsRucaparib

DrugsRucaparib

Overview

Phase: Phase 2
Intervention: Rucaparib
Conditions: Solid Tumor
Sponsor: pharmaand GmbH
Enrollment: 83
Locations: 18
Primary Endpoint: Best Overall Response Rate by Investigator
Status: Terminated
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

January 16, 2020

End Date

July 15, 2022

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

pharmaand GmbH

Responsible Party

Sponsor

Eligibility Criteria

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

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

Arms & Interventions

Rucaparib

Eligible participants will be enrolled in either Cohort A or Cohort B. Cohort A: Up to 200 participants with deleterious mutations in BRCA1, BRCA2, PALB2, RAD51C or RAD51D. Cohort B (Exploratory): Up to 20 participants with deleterious mutations in BARD1, BRIP1, FANCA, NBN, RAD51 or RAD51B.

Intervention: Rucaparib

Outcomes

Primary Outcomes

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 participants with advanced prostate cancer).

Secondary Outcomes

Disease Control Rate(From first dose of study drug until disease progression (up to approximately 2 years))
Overall Response Rate by Independent Radiology Review(From first dose of study drug until disease progression (up to approximately 2 years))
Progression-free Survival(From first dose of study drug until disease progression (up to approximately 2 years))
Number of Participants Experiencing Treatment-emergent Adverse Events(From first dose of study drug until disease progression (up to approximately 2 years))
Duration of Response(From first dose of study drug until disease progression (up to approximately 2 years))
Overall Survival(From first dose of study drug until disease progression (up to approximately 2 years))
Steady State Minimum Concentration [Cmin](From first dose of study drug until disease progression (up to approximately 2 years))