A Phase Ib/IIa, Open-Label, Dose Finding Study to Evaluate the Safety, Pharmacokinetics and Clinical Activity of PI3Kβ Selective Inhibitor (GSK2636771) Administered in Combination With Paclitaxel in Advanced Gastric Adenocarcinoma
Overview
- Phase
- Phase 1
- Intervention
- GSK2636771
- Conditions
- Advanced Gastric Adenocarcinoma
- Sponsor
- Yonsei University
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- Recommended Phase II dose
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
This is a Phase Ib/IIa, open-label, non-randomized, dose-escalation, multi-center study to evaluate the safety, tolerability, pharmacokinetics (PK), and clinical activity of oral GSK2636771 in combination with intravenous (IV) paclitaxel in two independent subject populations: subjects with PTEN-deficient, advanced gastric adenocarcinoma.
Detailed Description
This is a Phase Ib/IIa, open-label, non-randomized, dose-escalation, multi-center study to evaluate the safety, tolerability, pharmacokinetics (PK), and clinical activity of oral GSK2636771 in combination with intravenous (IV) paclitaxel in two independent subject populations: subjects with PTEN-deficient, advanced gastric adenocarcinoma. This study will be conducted in two phases: the Dose Escalation Phase and the Dose Expansion Phase. The Dose Escalation Phase (Phase Ib) is designed to determine the maximum tolerated dose (MTD) and the recommended Phase II dose (RP2D) of GSK2636771 administered in combination with paclitaxel. The Dose Expansion Phase (Phase IIa) will further evaluate the safety and clinical activity of the RP2D as determined in the Dose Escalation Phase.
Investigators
Sun Young Rha
Professor
Yonsei University
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Paclitaxel & GSK2636771
Increasing dose levels of GSK2636771 (300 mg or 400 mg once daily) in combination with a fixed dose of paclitaxel (80 mg/m2 on Days 1, 8 and 15 of a 28-day treatment cycle)
Intervention: GSK2636771
Paclitaxel & GSK2636771
Increasing dose levels of GSK2636771 (300 mg or 400 mg once daily) in combination with a fixed dose of paclitaxel (80 mg/m2 on Days 1, 8 and 15 of a 28-day treatment cycle)
Intervention: Paclitaxel
Outcomes
Primary Outcomes
Recommended Phase II dose
Time Frame: 4 weeks
Recommended Phase II dose for phase 1
Progression-free survival
Time Frame: 6 weeks
Progression-free survival for phase 2
Secondary Outcomes
- Dose limiting toxicity(28 days)