Study on Sapanisertib and Serabelisib with Paclitaxel and a Diet Substudy for Advanced or Recurrent Endometrial Cancer
Sponsor: Faeth Therapeutics
ClinicalTrials ID:NCT06463028
This clinical trial is testing a combination of drugs, sapanisertib and serabelisib, with paclitaxel to see if they are safe and effective for treating advanced or returning endometrial cancer. The study also includes a diet-related substudy.
Patient Parameters
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Program Overview
The purpose of this study is to evaluate how well a combination of drugs—sapanisertib, serabelisib, and paclitaxel—works in treating patients with advanced or recurrent endometrial cancer. This trial is for patients whose cancer has not responded to previous treatments, including platinum-based chemotherapy and immune checkpoint inhibitors.
Description
This study is designed to test the effectiveness and safety of a drug combination for patients with advanced or recurrent endometrial cancer. Participants in this trial have already tried other treatments, such as platinum-based chemotherapy and immune checkpoint inhibitors, but their cancer has not improved. The study will take place at multiple centers and will involve taking the drugs sapanisertib and serabelisib (PIKTOR) along with paclitaxel. There is also a substudy that looks at the effects of diet on treatment outcomes.
Eligibility Criteria
Inclusion Criteria
- Confirmed diagnosis of endometrial cancer.
- Cancer has advanced or returned and cannot be treated with surgery or radiation to cure it.
- Have tried at least one but no more than three previous treatments, including platinum-based chemotherapy and a checkpoint inhibitor.
- Have a specific gene alteration in the PI3K/AKT/mTOR pathway.
- Have at least one tumor that can be measured by scans.
- Be in good general health with an ECOG performance status of 0 or 1.
- Women must not be pregnant or breastfeeding and must agree to use effective birth control if they are of childbearing potential.
Exclusion Criteria
- Cancer has spread to the brain unless treated and stable without steroids for at least 4 weeks.
- Have had another active cancer within the last 2 years, except for certain treated skin cancers or in-situ carcinomas.
- Have digestive issues that affect the absorption of the study drugs.
- Have significant bleeding from the lungs or tumors.
- Have serious heart problems.
- Have an active, uncontrolled infection.
- Are participating in another clinical trial.
- Have had radiation therapy within 21 days before starting the study.
- Are taking certain medications that affect how the study drugs work.
- Have a prolonged QTc interval on an ECG.
- Have high blood sugar or triglycerides, or are on insulin treatment.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Women's Cancer Care Associates, LLC | 12208 | Albany | New York |
| Avera Cancer Institute | 57105 | Sioux Falls | South Dakota |
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