Brief Title
A Study to Evaluate Rucaparib in Combination With Other Anticancer Agents in Patients With a Solid Tumor (SEASTAR)
Official Title
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
Brief 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).
Study Phase
Phase 1/Phase 2
Study Type
Interventional
Primary Outcome
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Secondary Outcome
Duration of Response (Phase 2)
Condition
Ovarian Cancer
Intervention
Rucaparib
Study Arms / Comparison Groups
Arm A: Oral rucaparib and oral lucitanib
Description: Phase 1b (Dose escalation): Up to 55 patients with advanced or metastatic solid tumors. Phase 2 (Dose expansion): Up to 80 patients with High Grade Ovarian Cancer.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
329
Start Date
June 28, 2019
Completion Date
March 2024
Primary Completion Date
October 2023
Eligibility 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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
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Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT03992131
Organization ID
CO-338-098
Responsible Party
Sponsor
Study Sponsor
Clovis Oncology, Inc.
Collaborators
Gilead Sciences
Study Sponsor
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Verification Date
April 2021