Clinical Trials Directory

Trials / Completed

CompletedNCT02615730

PI3Kβ Selective Inhibitor With Paclitaxel, Advanced Gastric Adenocarcinoma

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

Status
Completed
Phase
Phase 1 / Phase 2
Study type
Interventional
Enrollment
42 (actual)
Sponsor
Yonsei University · Academic / Other
Sex
All
Age
19 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGGSK2636771Increasing dose levels of GSK2636771 (300 mg or 400 mg once daily)
DRUGPaclitaxelfixed dose of paclitaxel (80 mg/m2 on Days 1, 8 and 15 of a 28-day treatment cycle)

Timeline

Start date
2016-02-01
Primary completion
2021-03-31
Completion
2021-03-31
First posted
2015-11-26
Last updated
2025-01-24

Locations

1 site across 1 country: South Korea

Source: ClinicalTrials.gov record NCT02615730. Inclusion in this directory is not an endorsement.