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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.
Full 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.
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Inclusion criteria
Have histologically or cytologically confirmed locally advanced or metastatic solid tumors.
Have a tumor harboring a mutation in PIK3CA or KRAS genes.
Have received prior therapy and have recurrent or persistent disease without standard therapies available, or are ineligible to receive standard therapies.
Have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Have Eastern Cooperative Oncology Group performance status (ECOG PS) of ≤2
Have adequate organ function.
Have adequate birth control during the course of the study.
Are able to receive canagliflozin
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
60 participants in 1 patient group
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Central trial contact
Albert Yu, MD; Peggy Siemon-Hryczyk, MS
Data sourced from clinicaltrials.gov
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