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

• Status: Active, not recruiting
• Trial end date: 2024-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Clovis Oncology, Inc.
• Collaborators: Gilead Sciences; Immunomedics, Inc.
• Treatments: Antineoplastic Agents; Camptothecin; Immunoconjugates; Rucaparib

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