NCT03992131

A Study to Evaluate Rucaparib in Combination With Other Anticancer Agents in Participants 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

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: pharmaand GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

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

Interventions

Type	Name	Description
DRUG	Rucaparib	Rucaparib will be administered per schedule specified in the arm description.
DRUG	Lucitanib	Lucitanib will be administered per schedule specified in the arm description.
DRUG	Sacituzumab govitecan	Sacituzumab govitecan will be administered per schedule specified in the arm description.

Timeline

• Start date: 2019-06-28
• Primary completion: 2022-03-08
• Completion: 2022-04-22
• First posted: 2019-06-20
• Last updated: 2024-01-16
• Results posted: 2024-01-16

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study