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

NCT06463028 · Faeth Therapeutics
In plain English

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Official title
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
About this study
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
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.
Study design
Enrollment target: 40 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-12-12
Estimated completion: 2029-09
Last updated: 2025-12-24
Interventions
Drug: SapanisertibDrug: SerabelisibDrug: Paclitaxel
Primary outcomes
  • Objective Response Rate (ORR) (Up to 2 years)
Sponsor
Faeth Therapeutics · industry
With: GOG Foundation
Contacts & investigators
ContactMedical Monitor · contact · clinicaltrials@faeththerapeutics.com · (708)406-9282
All locations (18)
UC San Diego Moores Cancer CenterRecruiting
La Jolla, California, United States
University of California, San Francisco (UCSF)Recruiting
San Francisco, California, United States
Mount Sinai Comprehensive Cancer CenterRecruiting
Miami Beach, Florida, United States
Florida Cancer Specialists, NorthRecruiting
St. Petersburg, Florida, United States
Florida Cancer Specialists, EastRecruiting
West Palm Beach, Florida, United States
Maryland Oncology Hematology, P.A.Recruiting
Brandywine, Maryland, United States
Minnesota Oncology Hematology, P.A.Recruiting
Maple Grove, Minnesota, United States
Women's Cancer Care Associates, LLCRecruiting
Albany, New York, United States
Memorial Sloan Kettering Cancer CenterRecruiting
New York, New York, United States
University of Cincinnati Medical CenterRecruiting
Cincinnati, Ohio, United States
Oncology Associates of Oregon, P.C.Recruiting
Eugene, Oregon, United States
Northwest Cancer Specialists, P.C.Recruiting
Portland, Oregon, United States
Alliance Cancer Specialists, PCRecruiting
Doylestown, Pennsylvania, United States
West Penn HospitalRecruiting
Pittsburgh, Pennsylvania, United States
Avera Cancer InstituteRecruiting
Sioux Falls, South Dakota, United States
Texas Oncology - West TexasRecruiting
El Paso, Texas, United States
Texas Oncology - Gulf CoastRecruiting
The Woodlands, Texas, United States
Virginia Cancer Specialists, P.C.Recruiting
Fairfax, Virginia, United States
Sapanisertib and Serabelisib (PIKTOR) With Paclitaxel and a Substudy With an Insulin-Suppressing Diet in Patients With Advanced/Recurrent Endometrial Cancer · TrialPath