Study on Adding Sapanisertib to Usual Chemotherapy for Metastatic Liver Cancer with β-Catenin Gene Mutation (SAPHIRE Trial)
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT06811116
This clinical trial is testing whether adding the drug Sapanisertib to the usual chemotherapy treatment, Cabozantinib, can improve outcomes for patients with liver cancer that has spread and has a specific gene mutation. The study aims to find the best dose and evaluate the effectiveness of this combination.
Patient Parameters
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Program Overview
This study is exploring the effects of combining two drugs, Sapanisertib and Cabozantinib, to treat liver cancer that has spread to other parts of the body and has a mutation in the β-catenin gene. The goal is to determine the best dose of Sapanisertib and to see if this combination works better than Cabozantinib alone in stopping cancer growth. Both drugs may help by blocking enzymes that cancer cells need to grow.
Description
The study is divided into two phases. In Phase I, researchers will determine the safest and most effective dose of Sapanisertib when used with Cabozantinib in patients with advanced liver cancer. In Phase II, the study will compare the effectiveness of the combination treatment against Cabozantinib alone in patients with a specific gene mutation.
Primary goals include finding the best dose and evaluating how long patients live without the cancer getting worse. Secondary goals involve assessing the overall response rate, survival, and safety of the treatment. Researchers will also look at specific molecular markers and how the drugs are processed in the body.
Participants in Phase I will receive both Sapanisertib and Cabozantinib daily. In Phase II, participants will be randomly assigned to receive either the combination treatment or Cabozantinib alone. Treatment cycles last 28 days and continue unless the cancer progresses or side effects become unacceptable. Patients will have regular blood tests and scans to monitor their health and the treatment's effects.
After completing the study treatment, participants will have follow-up visits every three months for two years to check on their health and any long-term effects of the treatment.
Eligibility Criteria
Inclusion Criteria
- Must have confirmed liver cancer that cannot be cured with surgery or other treatments.
- For Phase II, must have measurable cancer that can be tracked with scans.
- Must have a specific mutation in the β-catenin gene, confirmed by a lab test.
- Must have tried at least one previous treatment for metastatic cancer, including immune therapy if eligible.
- Must be 18 years or older.
- Must have a good performance status and liver function.
- Must have adequate blood cell counts and kidney function.
- HIV-positive patients must have an undetectable viral load.
- Hepatitis B and C patients must have controlled or treated infections.
- Patients with stable brain metastases are eligible.
- Must agree to use effective birth control during and after the study.
- Must be able to understand and sign a consent form.
Exclusion Criteria
- Cannot have unresolved side effects from previous cancer treatments.
- Cannot be taking other experimental drugs.
- Cannot have allergies to similar drugs.
- Cannot take certain medications that interact with Cabozantinib.
- Cannot have taken Cabozantinib before.
- Cannot have conditions that prevent swallowing pills.
- Cannot have uncontrolled illnesses that make participation unsafe.
- Pregnant or breastfeeding women cannot participate due to potential risks to the baby.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care | 92612 | Irvine | California |
| UC Irvine Health/Chao Family Comprehensive Cancer Center | 92868 | Orange | California |
| Oregon Health and Science University | 97239 | Portland | Oregon |
| University of Pittsburgh Cancer Institute (UPCI) | 15232 | Pittsburgh | Pennsylvania |
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