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A Phase 1b/2 Study of Serabelisib in Combination With Canagliflozin in Patients With Advanced Solid Tumors

Breast Cancer Clinical Trial

Official title:
A Phase 1b/2 Study of Serabelisib in Combination With Canagliflozin in Patients With Advanced Solid Tumors With PIK3CA or KRAS Mutations

Clinical Trial Summary

This study aims to test the hypothesis that combining serabelisib, a PI3K alpha isoform inhibitor, with an SGLT2 inhibitor, canagliflozin will improve efficacy in the treatment of patients with advanced solid tumors.

Clinical Trial Description

This study aims to test the hypothesis that controlling the glucose/insulin feedback will enhance the efficacy of PI3K inhibition in treating solid tumors. The treatment consists of serabelisib, a PI3K alpha isoform (PI3Kα) inhibitor, combined with the sodium-glucose cotransporter-2 (SGLT2) inhibitor canagliflozin. The study will assess the safety and efficacy of the combination in adult patients with advanced solid tumors harboring mutations that may be dependent on PI3Kα activity: PIK3CA mutations and KRAS mutations. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04073680
Study type Interventional
Source Petra Pharma
Contact Albert Yu, MD
Phone 646-440-9218
Email ayu@petrapharmacorp.com
Status Not yet recruiting
Phase Phase 1/Phase 2
Start date September 1, 2020
Completion date December 30, 2021
View Details
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