A Phase I/II Trial of Sapanisertib in Combination With Cabozantinib in β-catenin-mutated Hepatocellular Carcinoma (SAPHIRE)
National Cancer Institute (NCI)
Summary
This phase I/II trial studies the side effects and best dose of sapanisertib when given together with cabozantinib, and to see how well they work in treating patients with liver cancer that has spread from where it first started to other places in the body (metastatic) and contains a mutation (change) in the β-catenin gene. Sapanisertib and cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving sapanisertib and cabozantinib together may work better than giving cabozantinib alone in treating β-catenin-mutated metastatic hepatocellular carcinoma.
Description
PRIMARY OBJECTIVES: I. To establish the recommended phase 2 dose (RP2D) of the combination of sapanisertib and cabozantinib in advanced hepatocellular carcinoma (HCC) patients. (Safety Lead-In \[Phase I\]) II. To determine the activity by progression free survival (PFS) of the combination of sapanisertib and cabozantinib versus (vs) cabozantinib alone in advanced β-catenin mutated HCC patients. (Phase II) SECONDARY OBJECTIVES: I. To estimate the activity by objective response rate (ORR) of the combination of sapanisertib and cabozantinib versus cabozantinib alone in advanced β-catenin mutat…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patients must have histologically or cytologically confirmed HCC, not amenable to curative treatment approach * For Phase 2, patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥ 20 mm (≥ 2 cm) by chest x-ray or as ≥ 10 mm (≥ 1 cm) with CT scan, MRI, or calipers by clinical exam * For phase 2, patients must have a β-catenin mutation, based on next generation eequencing (NGS) testing through Clinical Labora…
Interventions
- ProcedureBiospecimen Collection
Undergo blood collection
- DrugCabozantinib S-malate
Given PO
- ProcedureImaging Procedure
Undergo imaging scans
- DrugSapanisertib
Given orally (PO)
Locations (4)
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory CareIrvine, California
- UC Irvine Health/Chao Family Comprehensive Cancer CenterOrange, California
- Oregon Health and Science UniversityPortland, Oregon
- University of Pittsburgh Cancer Institute (UPCI)Pittsburgh, Pennsylvania