RecruitingPhase 2NCT06463028

Sapanisertib and Serabelisib (PIKTOR) With Paclitaxel and a Substudy With an Insulin-Suppressing Diet in Patients With Advanced/Recurrent Endometrial Cancer

An Open-label, Multi-Center, Phase 2 Clinical Trial Evaluating Sapanisertib and Serabelisib (PIKTOR) With Paclitaxel, and a Substudy Evaluating PIKTOR With Paclitaxel Plus an Insulin-Suppressing Diet, in Patients With Advanced or Recurrent Endometrial Cancer

Sponsor

Faeth Therapeutics

Enrollment

40 participants

Start Date

Dec 12, 2024

Study Type

INTERVENTIONAL

Conditions

Endometrial Cancer

Summary

This is a Phase 2, multicenter, open-label, single-arm study to evaluate the efficacy and safety of sapanisertib and serabelisib (PIKTOR) with paclitaxel in participants with advanced or recurrent endometrial cancer.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests a combination of two drugs — sapanisertib and serabelisib — with paclitaxel chemotherapy in people with advanced or recurrent endometrial (uterine) cancer that has a mutation in a specific molecular pathway (PI3K/AKT/mTOR). An optional substudy also tests a low-insulin diet alongside the drugs. **You may be eligible if...** - You have confirmed endometrioid endometrial cancer that has come back or spread - You are not a candidate for surgery or radiation with curative intent - You have received at least 1 but no more than 4 prior systemic therapies, including platinum-based chemotherapy AND a checkpoint inhibitor (immunotherapy) - Your tumor has a PI3K/AKT/mTOR pathway gene mutation - You are in good health (ECOG ≤1) and not pregnant **You may NOT be eligible if...** - You have active brain metastases (or have not finished steroid treatment for them) - You have another active cancer within the past 2 years - You have gastrointestinal issues affecting drug absorption (feeding tube, bowel obstruction, or malabsorption) - You have significant bleeding from tumors Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSapanisertib

Oral

DRUGSerabelisib

Oral

DRUGPaclitaxel

Infusion

Locations(18)

UC San Diego Moores Cancer Center

La Jolla, California, United States

University of California, San Francisco (UCSF)

San Francisco, California, United States

Mount Sinai Comprehensive Cancer Center

Miami Beach, Florida, United States

Florida Cancer Specialists, North

St. Petersburg, Florida, United States

Florida Cancer Specialists, East

West Palm Beach, Florida, United States

Maryland Oncology Hematology, P.A.

Brandywine, Maryland, United States

Minnesota Oncology Hematology, P.A.

Maple Grove, Minnesota, United States

Women's Cancer Care Associates, LLC

Albany, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

University of Cincinnati Medical Center

Cincinnati, Ohio, United States

Oncology Associates of Oregon, P.C.

Eugene, Oregon, United States

Northwest Cancer Specialists, P.C.

Portland, Oregon, United States

Alliance Cancer Specialists, PC

Doylestown, Pennsylvania, United States

West Penn Hospital

Pittsburgh, Pennsylvania, United States

Avera Cancer Institute

Sioux Falls, South Dakota, United States

Texas Oncology - West Texas

El Paso, Texas, United States

Texas Oncology - Gulf Coast

The Woodlands, Texas, United States

Virginia Cancer Specialists, P.C.

Fairfax, Virginia, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06463028

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