Sapanisertib and Serabelisib (PIKTOR) With Paclitaxel and a Substudy With an Insulin-Suppressing Diet in Patients With Advanced/Recurrent Endometrial Cancer
NCT ID: NCT06463028
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
40 participants
INTERVENTIONAL
2024-12-12
2029-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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sapanisertib and serabelisib (PIKTOR) with paclitaxel
Subjects will receive doses of sapanisertib and serabelisib (PIKTOR) administered orally and paclitaxel administered intravenously.
Sapanisertib
Oral
Serabelisib
Oral
Paclitaxel
Infusion
Interventions
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Sapanisertib
Oral
Serabelisib
Oral
Paclitaxel
Infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
FEMALE
No
Sponsors
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GOG Foundation
NETWORK
Faeth Therapeutics
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Central Contacts
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References
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Starks DC, Rojas-Espaillat L, Meissner T, Williams CB. Phase I dose escalation study of dual PI3K/mTOR inhibition by Sapanisertib and Serabelisib in combination with paclitaxel in patients with advanced solid tumors. Gynecol Oncol. 2022 Sep;166(3):403-409. doi: 10.1016/j.ygyno.2022.07.005. Epub 2022 Jul 15.
Related Links
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Related Info
Other Identifiers
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FTH-PIK-201
Identifier Type: -
Identifier Source: org_study_id
GOG-3111
Identifier Type: OTHER
Identifier Source: secondary_id