A Study to Evaluate Rucaparib in Combination With Other Anticancer Agents in Patients With a Solid Tumor (SEASTAR)

Status: Active

Description

This is an open label, Phase 1b / 2 study with multiple treatment arms evaluating the safety, tolerability, PK, and preliminary efficacy of rucaparib in combination with a second anticancer therapy in patients with an advanced / metastatic solid malignancy (Phase 1b), followed by evaluation of the combination in one or more specific patient populations in an expansion phase (Phase 2 cohorts).

Eligibility Criteria

Inclusion Criteria

  • Inclusion Criteria Phase 1b (all arms): - Solid tumor, advanced or metastatic, progressed on standard treatment Patients in Arm B must have either triple negative breast cancer OR urothelial carcinoma OR ovarian cancer OR have a solid tumor with a deleterious mutation in BRCA1, BRCA2, PALB2, RAD51C or RAD51D - Measurable disease per RECIST v1.1 - Adequate organ function - ECOG 0 or 1 - Tumor tissue for genomic analysis Exclusion Criteria Phase 1b (all arms): - Known history of MDS - Symptomatic and/or untreated CNS metastases Inclusion Criteria Phase 2 (all arms): - Histologically or cytologically confirmed solid tumor, previously treated and measurable per RECIST v1.1, as follows: - Arm A: ovarian cancer with gBRCAwt disease, either platinum-sensitive OR platinum-resistant - Arm B: Metastatic triple negative breast cancer OR advanced/ metastatic urothelial carcinoma OR relapsed ovarian cancer - At least 1 prior line of standard therapy for advanced disease - Adequate organ function - ECOG 0 or 1 - Tumor tissue for genomic analysis Exclusion Criteria Phase 2 (all arms): - Prior PARPi treatment allowed for patients with ovarian cancer - Known history of MDS - Symptomatic and/or untreated CNS metastases

Locations & Contacts

Massachusetts

Boston
Brigham and Women's Hospital
Status: Active
Name Not Available
Dana-Farber Cancer Institute
Status: Active
Name Not Available

Texas

Houston
M D Anderson Cancer Center
Status: Active
Name Not Available

Trial Phase & Type

Trial Phase

Phase I/II

Trial Type

Treatment

Lead Organization

Lead Organization
Clovis Oncology

Trial IDs

Primary ID CO-338-098
Secondary IDs NCI-2019-04655
Clinicaltrials.gov ID NCT03992131