Combination of Serabelisib and Insulin Suppressing Diet With or Without Nab-paclitaxel in Subjects With Advanced Solid Tumors With PIK3CA Mutations

PHASE1CompletedINTERVENTIONAL
Enrollment

34

Participants

Timeline

Start Date

April 22, 2022

Primary Completion Date

April 30, 2025

Study Completion Date

April 30, 2025

Conditions
Advanced Solid TumorPIK3CA MutationPTEN Loss of Function Mutation
Interventions
DRUG

Serabelisib

serabelisib administered orally

OTHER

Insulin Suppressing Diet

3 meals consumed daily (i.e., breakfast, lunch, dinner) and optional snacks provided dependent on caloric needs

DRUG

Nab paclitaxel

nab-paclitaxel administered intravenously weekly

Trial Locations (17)

10065

Memorial Sloan Kettering Cancer Center, New York

11042

Northwell Health, Lake Success

19104

University of Pennsylvania Health System, Perelman Center for Advanced Medicine, Philadelphia

27858

East Carolina University, Greenville

35429

University of Alabama, Birmingham

46250

Community Health Network, Inc., Indianapolis

53226

Medical College of Wisconsin, Milwaukee

55902

Mayo Clinic - Rochester, Rochester

57105

Avera Cancer Institute, Sioux Falls

77030

Oncology Consultants, PA, Houston

77339

Lumi Research, Kingwood

77701

Baptist Hospitals of Southeast Texas, Beaumont

90067

Valkyrie Clinical Trials, Los Angeles

92663

Hoag Memorial Hospital Presbyterian, Newport Beach

92801

Pacific Cancer Specialists, Anaheim

07109

New Jersey Cancer Care, PA, Belleville

07631

Englewood Health, Englewood

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Faeth Therapeutics

INDUSTRY