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

pharmaand

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Solid Tumor; Urothelial Carcinoma; Triple-negative Breast Cancer; Ovarian Cancer

Treatments: Drug: Sacituzumab govitecan; Drug: Rucaparib; Drug: Lucitanib

Study type: Interventional

Funder types: Industry

Identifiers

NCT03992131

2018-003759-39 (EudraCT Number)

CO-338-098

Details and patient eligibility

About

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

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria Phase 1b (all arms):

• Solid tumor, advanced or metastatic, progressed on standard treatment participants 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
• Eastern Cooperative Oncology Group (ECOG) 0 or 1
• Tumor tissue for genomic analysis

Exclusion Criteria Phase 1b (all arms):

• Known history of myelodysplastic syndrome (MDS)
• Symptomatic and/or untreated central nervous system (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 poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitor treatment allowed for participants with ovarian cancer
• Known history of MDS
• Symptomatic and/or untreated CNS metastases

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 3 patient groups

Arm A: Rucaparib and Lucitanib

Experimental group

Description:

Participants will receive oral rucaparib twice daily (BID) and oral lucitanib once daily (QD) continuously in 28-day cycles.

Treatment:

Drug: Rucaparib

Drug: Lucitanib

Arm B: Rucaparib BID and Sacituzumab Govitecan

Experimental group

Description:

Participants will receive oral rucaparib BID, administered continuously, in combination with intravenous (IV) sacituzumab govitecan administration on Day 1 and Day 8 of a 21-day cycle.

Treatment:

Drug: Sacituzumab govitecan

Drug: Rucaparib

Arm B: Rucaparib QD and Sacituzumab Govitecan

Experimental group

Description:

Participants will receive oral rucaparib QD, administered continuously, in combination with IV sacituzumab govitecan administration on Day 1 and Day 8 of a 21-day cycle.

Treatment:

Drug: Sacituzumab govitecan

Drug: Rucaparib