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

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Number of Participants With Objective Response

Primary Outcome 1 - Timeframe: From the first dose of study drug until the date of documented response to treatment

Primary Outcome 2 - Measure: as Assessed by the Investigator Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v)1.1 (Phase 2)

Primary Outcome 2 - Timeframe: assessed up to 2 years

CONDITION

• Ovarian Cancer
• Triple-negative Breast Cancer
• Urothelial Carcinoma
• Solid Tumor

ELIGIBILITY

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

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Overall Contact

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