PI3Kβ Selective Inhibitor With Paclitaxel, Advanced Gastric Adenocarcinoma
Status:
Completed
Trial end date:
2021-03-31
Target enrollment:
Participant gender:
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. 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.