Spots Global Cancer Trial Database for PI3Kβ Selective Inhibitor With Paclitaxel, Advanced Gastric Adenocarcinoma
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Trial Identification
Brief Title: PI3Kβ Selective Inhibitor With Paclitaxel, Advanced Gastric Adenocarcinoma
Official Title: 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 Having Alterations in PI3K Pathway Genes
Study ID: NCT02615730
Conditions
Study Description
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. 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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 19 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Severance Hospital, Yonsei University Health System, Yonsei Cancer Center, Seoul, , Korea, Republic of
Contact Details
Name: Sun Young Rha
Affiliation: Yonsei Cancer Center
Role: PRINCIPAL_INVESTIGATOR
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