Breast Cancer Clinical Trial

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

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).

View Eligibility Criteria

Eligibility 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

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

25

Study ID:

NCT03992131

Recruitment Status:

Terminated

Sponsor:

pharmaand GmbH

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There are 3 Locations for this study

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Dana Farber Cancer Institute
Boston Massachusetts, 02215, United States
Sarah Cannon Research Institute
Nashville Tennessee, 37203, United States
MD Anderson Cancer Center
Houston Texas, 77030, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

25

Study ID:

NCT03992131

Recruitment Status:

Terminated

Sponsor:


pharmaand GmbH

How clear is this clinincal trial information?

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