NCT02615730

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

Completed Phase 1/Phase 2 Last updated 21 January 2025

What this trial tests

Phase 1/Phase 2 trial testing GSK2636771 in Advanced Gastric Adenocarcinoma in 42 participants. Completed in 31 March 2021.

Timeline

1 February 2016

Primary endpoint
31 March 2021

31 March 2021

Quick facts

Lead sponsor	Yonsei University
Phase	Phase 1/Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	42
Start date	1 February 2016
Primary completion	31 March 2021
Estimated completion	31 March 2021
Sites	1 location across South Korea

Drugs / interventions tested

• GSK2636771 — full drug profile →
• Paclitaxel — full drug profile →

Conditions studied

• Advanced Gastric Adenocarcinoma — all drugs for Advanced Gastric Adenocarcinoma →

Sponsor

Yonsei University

Who can join

19 and older, any sex, with Advanced Gastric Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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

Sponsor's own 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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Targeting PI3K in cancer: mechanisms and advances in clinical trials.
   Yang J, Nie J, Ma X, Wei Y, et al · · 2019 · cited 1142× · PMID 30782187 · DOI 10.1186/s12943-019-0954-x
2. Role of PI3K/AKT pathway in cancer: the framework of malignant behavior.
   Jiang N, Dai Q, Su X, Fu J, et al · · 2020 · cited 419× · PMID 32333246 · DOI 10.1007/s11033-020-05435-1
3. Tumor biomarkers for diagnosis, prognosis and targeted therapy.
   Zhou Y, Tao L, Qiu J, Xu J, et al · · 2024 · cited 379× · PMID 38763973 · DOI 10.1038/s41392-024-01823-2
4. Comprehensive expression profiles of gastric cancer molecular subtypes by immunohistochemistry: implications for individualized therapy.
   Kim HS, Shin SJ, Beom SH, Jung M, et al · · 2016 · cited 45× · PMID 27331626 · DOI 10.18632/oncotarget.10115
5. Emerging Therapies in the Management of Advanced-Stage Gastric Cancer.
   Kumar V, Soni P, Garg M, Kamholz S, et al · · 2018 · cited 26× · PMID 30271341 · DOI 10.3389/fphar.2018.00404
6. New Treatment Opportunities in Phosphatase and Tensin Homolog (PTEN)-Deficient Tumors: Focus on PTEN/Focal Adhesion Kinase Pathway.
   Alfieri R, Giovannetti E, Bonelli M, Cavazzoni A. · · 2017 · cited 24× · PMID 28848709 · DOI 10.3389/fonc.2017.00170
7. Molecular mechanisms underlying the action of carcinogens in gastric cancer with a glimpse into targeted therapy.
   Patrad E, Khalighfard S, Amiriani T, Khori V, et al · · 2022 · cited 23× · PMID 36149600 · DOI 10.1007/s13402-022-00715-3
8. Towards precision medicine: linking genetic and cellular heterogeneity in gastric cancer.
   Carrasco-Garcia E, García-Puga M, Arevalo S, Matheu A. · · 2018 · cited 18× · PMID 30181784 · DOI 10.1177/1758835918794628