SEASTAR: A Phase 1b/2, Open-label, Parallel Arm Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Oral Rucaparib in Combination With Other Anticancer Agents in Patients With a Solid Tumor

Condition: Ovarian Cancer, Triple-negative Breast Cancer, Urothelial Carcinoma, Solid Tumor

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03992131

Sponsor: Clovis Oncology, Inc.

Phase: Phase 1/Phase 2

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: All

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 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

View trial on ClinicalTrials.gov