Actively Recruiting
Sapanisertib and Serabelisib (PIKTOR) With Paclitaxel and a Substudy With an Insulin-Suppressing Diet in Patients With Advanced/Recurrent Endometrial Cancer
Led by Faeth Therapeutics · Updated on 2025-12-24
40
Participants Needed
18
Research Sites
246 weeks
Total Duration
On this page
Sponsors
F
Faeth Therapeutics
Lead Sponsor
G
GOG Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Sapanisertib and Serabelisib (PIKTOR) With Paclitaxel and a Substudy With an Insulin-Suppressing Diet in Patients With Advanced/Recurrent Endometrial Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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..
You will not qualify if you...
- 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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 18 locations
1
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92037
Actively Recruiting
2
University of California, San Francisco (UCSF)
San Francisco, California, United States, 94158
Actively Recruiting
3
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States, 33140
Actively Recruiting
4
Florida Cancer Specialists, North
St. Petersburg, Florida, United States, 33705
Actively Recruiting
5
Florida Cancer Specialists, East
West Palm Beach, Florida, United States, 33401
Actively Recruiting
6
Maryland Oncology Hematology, P.A.
Brandywine, Maryland, United States, 20613
Actively Recruiting
7
Minnesota Oncology Hematology, P.A.
Maple Grove, Minnesota, United States, 55369
Actively Recruiting
8
Women's Cancer Care Associates, LLC
Albany, New York, United States, 12208
Actively Recruiting
9
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
10
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 46214
Actively Recruiting
11
Oncology Associates of Oregon, P.C.
Eugene, Oregon, United States, 97401
Actively Recruiting
12
Northwest Cancer Specialists, P.C.
Portland, Oregon, United States, 97227
Actively Recruiting
13
Alliance Cancer Specialists, PC
Doylestown, Pennsylvania, United States, 18901
Actively Recruiting
14
West Penn Hospital
Pittsburgh, Pennsylvania, United States, 15224
Actively Recruiting
15
Avera Cancer Institute
Sioux Falls, South Dakota, United States, 57105
Actively Recruiting
16
Texas Oncology - West Texas
El Paso, Texas, United States, 79902
Actively Recruiting
17
Texas Oncology - Gulf Coast
The Woodlands, Texas, United States, 77380
Actively Recruiting
18
Virginia Cancer Specialists, P.C.
Fairfax, Virginia, United States, 22031
Actively Recruiting
Research Team
M
Medical Monitor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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