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
Trial Description
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).
Eligibility Requirements
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