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

Last updated: March 13, 2025
Sponsor: Faeth Therapeutics
Overall Status: Active - Recruiting

Phase

2

Condition

Endometrial Cancer

Vaginal Cancer

Pelvic Cancer

Treatment

Paclitaxel

Sapanisertib

Serabelisib

Clinical Study ID

NCT06463028
FTH-PIK-201
GOG-3111
  • Ages > 18
  • Female

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Histologically confirmed diagnosis of endometrioid endometrial carcinoma.

  • Documented evidence of advanced or recurrent endometrial cancer that is not amenableto surgery/radiation for curative intent.

  • Participant has received at least 1 but not more than 3 prior systemic therapies.Prior therapy must include platinum-based chemotherapy and a checkpoint inhibitor,either separately or in combination.

  • 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 orwho agree to use effective contraceptive methods..

Exclusion

Exclusion Criteria:

  • Participants with central nervous system metastases are not eligible, unless theyhave completed local therapy and have discontinued the use of corticosteroids forthis indication for at least 4 weeks before starting treatment in this study

  • Active malignancy (except for endometrial cancer, definitively treated in-situcarcinomas [e.g., breast, cervix, bladder], or basal or squamous cell carcinoma ofthe skin) within the past 24 months prior to treatment. Fully resected localizedmalignancies are eligible.

  • Gastrointestinal malabsorption, gastrointestinal anastomosis, bowel obstruction, orany other condition that might affect the absorption of study treatment.

  • Clinically significant 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, strong CYP1A2 inhibitors or CYP1A2 inducers, or clinicallysignificant CYP3A4 inducers within 7 days before the first dose of studyintervention, or participants who require treatment with strong CYP3A4 inhibitors orinducers during the study.

  • Participants who require PPIs or chronic use of antacids, histamine H2 receptorblockers, or other treatments to raise gastric pH.

  • Prolongation of QTc interval to >480 ms.

  • HbA1c ≥ 8.0%, fasting serum glucose > 160 mg/dL, fasting triglycerides > 300 mg/dLor receiving treatment with insulin.

Study Design

Total Participants: 40
Treatment Group(s): 3
Primary Treatment: Paclitaxel
Phase: 2
Study Start date:
December 12, 2024
Estimated Completion Date:
September 30, 2029

Study 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.

Connect with a study center

  • UC San Diego Moores Cancer Center

    La Jolla, California 92037
    United States

    Active - Recruiting

  • Mount Sinai Comprehensive Cancer Center

    Miami Beach, Florida 33140
    United States

    Active - Recruiting

  • Florida Cancer Specialists, North

    Saint Petersburg, Florida 33705
    United States

    Active - Recruiting

  • Florida Cancer Specialists, East

    West Palm Beach, Florida 33401
    United States

    Active - Recruiting

  • Minnesota Oncology Hematology, P.A.

    Maple Grove, Minnesota 55369
    United States

    Active - Recruiting

  • Women's Cancer Care Associates, LLC

    Albany, New York 12208
    United States

    Active - Recruiting

  • Oncology Associates of Oregon, P.C.

    Eugene, Oregon 97401
    United States

    Active - Recruiting

  • Northwest Cancer Specialists, P.C.

    Portland, Oregon 97227
    United States

    Active - Recruiting

  • Alliance Cancer Specialists, PC

    Doylestown, Pennsylvania 18901
    United States

    Active - Recruiting

  • Avera Cancer Institute

    Sioux Falls, South Dakota 57105
    United States

    Active - Recruiting

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