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NCT06463028PHASE2Recruiting

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

Faeth Therapeutics

Start Date

12/12/2024

Completion Date

9/1/2029

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.

Detailed Description

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 who have failed prior systemic therapies, including a platinum-based therapy and an immune checkpoint inhibitor, either separately or together.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Histologically confirmed diagnosis of endometrioid endometrial carcinoma. * Documented evidence of advanced or recurrent endometrial cancer that is not amenable to surgery/radiation for curative intent. * Participant has received at least 1 but not more than 4 prior systemic therapies. Prior therapy must include platinum-based chemotherapy and a checkpoint inhibitor, either separately or in combination. If a subject has been unable to be treated with checkpoint inhibitor in the past due to medical contraindications, consult with Medical Monitor. * PI3K/AKT/mTOR pathway gene alteration identified. * At least 1 measurable target lesion according to RECIST v1.1 * Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 at Screening. * Non-pregnant, non-lactating females who are postmenopausal, surgically sterile or who agree to use effective contraceptive methods.. Exclusion Criteria: * Participants with central nervous system metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting treatment in this study * Active malignancy (except for endometrial cancer, definitively treated in-situ carcinomas \[e.g., breast, cervix, bladder\], or basal or squamous cell carcinoma of the skin) within the past 24 months prior to treatment. Fully resected localized malignancies are eligible. * Gastric feeding tube (gastrostomy tube), gastrointestinal malabsorption, gastrointestinal anastomosis, bowel obstruction, or any other condition that might affect the absorption of study treatment. * Clinically significant (per Investigator judgement) hemoptysis or tumor bleeding. * Significant cardiovascular impairment. * Active, uncontrolled (requiring systemic antimicrobial therapy) infection. * Concurrent participation in another therapeutic clinical trial. * Prior radiation therapy within 21 days prior to start of study treatment. * Strong CYP3A4 inhibitors and inducers are prohibited during the study. Strong CYP1A2 inhibitors as well as CYP1A2 inducers should be administered with caution and at the discretion of the Investigator. Alternative treatments, if available, should be considered. Additionally, strong CYP3A4 inhibitors or inducers should not be taken within 7 days before the first dose of study intervention. * Participants who require PPIs or chronic use of antacids, histamine H2 receptor blockers, or other treatments to raise gastric pH. * Prolongation of QTc interval to \>480 ms. * HbA1c ≥ 8.0% or fasting serum glucose \> 160 mg/dL or fasting triglycerides \> 300 mg/dL or receiving treatment with insulin.

Interventions

DRUG

Sapanisertib

DRUG

Serabelisib

DRUG

Paclitaxel

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Conditions

Endometrial Cancer

Locations

UC San Diego Moores Cancer Center

La Jolla, California 92037

United States

University of California, San Francisco (UCSF)

San Francisco, California 94158

United States

Mount Sinai Comprehensive Cancer Center

Miami Beach, Florida 33140

United States

Florida Cancer Specialists, North

St. Petersburg, Florida 33705

United States

Florida Cancer Specialists, East

West Palm Beach, Florida 33401

United States

Maryland Oncology Hematology, P.A.

Brandywine, Maryland 20613

United States

Minnesota Oncology Hematology, P.A.

Maple Grove, Minnesota 55369

United States

Women's Cancer Care Associates, LLC

Albany, New York 12208

United States

Memorial Sloan Kettering Cancer Center

New York, New York 10065

United States

University of Cincinnati Medical Center

Cincinnati, Ohio 46214

United States

Oncology Associates of Oregon, P.C.

Eugene, Oregon 97401

United States

Northwest Cancer Specialists, P.C.

Portland, Oregon 97227

United States

Alliance Cancer Specialists, PC

Doylestown, Pennsylvania 18901

United States

West Penn Hospital

Pittsburgh, Pennsylvania 15224

United States

Avera Cancer Institute

Sioux Falls, South Dakota 57105

United States

Texas Oncology - West Texas

El Paso, Texas 79902

United States

Texas Oncology - Gulf Coast

The Woodlands, Texas 77380

United States

Virginia Cancer Specialists, P.C.

Fairfax, Virginia 22031

United States