PI3Kβ Selective Inhibitor With Paclitaxel, Advanced Gastric Adenocarcinoma

Phase 1

Completed

• Conditions: Advanced Gastric Adenocarcinoma
• Interventions: Drug: GSK2636771; Drug: Paclitaxel

• Registration Number: NCT02615730
• Lead Sponsor: Yonsei University

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.

Study Timeline

• Study First Submitted: 2015-11-24
• Study First Submitted QC: 2015-11-24
• Study First Posted: 2015-11-26
• Study Start: 2016-02
• Primary Completion: 2021-03-31
• Study Completion: 2021-03-31
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-21
• Last Update Posted: 2025-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Paclitaxel & GSK2636771	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)
Paclitaxel & GSK2636771	Paclitaxel	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)

Primary Outcome Measures

Name	Time	Method
Recommended Phase II dose	4 weeks	Recommended Phase II dose for phase 1
Progression-free survival	6 weeks	Progression-free survival for phase 2

Secondary Outcome Measures

Name	Time	Method
Dose limiting toxicity	28 days	Dose limiting toxicity for phase 1

Trial Locations

Locations (1)

Severance Hospital, Yonsei University Health System, Yonsei Cancer Center; 🇰🇷 Seoul, Korea, Republic of