Combination of Serabelisib and Insulin Suppressing Diet With or Without Nab-paclitaxel in Subjects With Advanced Solid Tumors With PIK3CA Mutations
This study will evaluate the feasibility of optimizing the safety and tolerability of serabelisib (an investigational PI3K inhibitor) when combined with an ISD and with or without nab-paclitaxel with a goal of reducing side effects and enhancing anticancer activity.
Study Type : Interventional (Clinical Trial)- Estimated Enrollment : 68 participants
- Allocation : Non-Randomized
- Intervention Model : Single Group Assignment
- Masking : None (Open Label)
- Primary Purpose : Treatment
- Official Title : A Phase 1b Study of Serabelisib in Combination With an Insulin Suppressing Diet (Study ISD) and With or Without Nab-paclitaxel in Adult Subjects With Advanced Solid Tumors With PIK3CA Mutations With or Without PTEN Loss
- Actual Study Start Date : April 22, 2022
- Estimated Primary Completion Date : September 2024
- Estimated Study Completion Date : September 2024
ClinicalTrials.gov Identifier:NCT05300048
Sponsor:Faeth Therapeutics
Information provided by (Responsible Party): Faeth Therapeutics
View this trial on clinicaltrials.gov.
What is a Clinical Trial?
A clinical trial is required by the FDA for any new therapy to come to market. It involves recruiting volunteers to help prove the therapy actually works. Every pill that you take or procedure that is performed by physicians has went through a clinical trial