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PI3Kβ Selective Inhibitor With Paclitaxel, Advanced Gastric Adenocarcinoma

NCT02615730 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2025-01-24

No results posted yet for this study

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.

Conditions

  • Advanced Gastric Adenocarcinoma

Interventions

DRUG

GSK2636771

Increasing dose levels of GSK2636771 (300 mg or 400 mg once daily)

DRUG

Paclitaxel

fixed dose of paclitaxel (80 mg/m2 on Days 1, 8 and 15 of a 28-day treatment cycle)

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Principal Investigators

  • Sun Young Rha · Yonsei Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2021-03-31
Completion
2021-03-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02615730 on ClinicalTrials.gov