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

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

INTRODUCTION

  • Org Study ID: CO-338-098
  • Secondary ID: N/A
  • NCT ID: NCT03992131
  • Sponsor: pharmaand GmbH

BRIEF SUMMARY

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).

  • Overall Status
    Terminated
  • Start Date
    June 28, 2019
  • Phase
    PHASE1, PHASE2
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A

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

Name: N/A

Role: N/A

Affiliation: N/A

Overall Contact

Name: N/A

Phone: N/A

Email: N/A

LOCATION

Facility Status Contact