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
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.
Arms & interventions
- DrugSapanisertib
Oral
- DrugSerabelisib
Oral
- DrugPaclitaxel
Infusion
Outcome measures
Primary
Objective Response Rate (ORR)
Defined as the proportion of participants with measurable disease at baseline who have confirmed complete response (CR) or partial response (PR).
Time frame: Up to 2 years
Secondary
Progression free survival (PFS)
Time frame: Up to 5 years.
Progression free survival (PFS) at 6 months
Time frame: Up to 5 years.
Overall survival (OS)
Time frame: Up to 5 years.
Clinical benefit rate (CBR)
Time frame: Up to 5 years.
Duration of response (DoR)
Time frame: Up to 5 years.
Safety and tolerability of drugs by assessment of adverse events (AEs) / serious adverse events (SAEs)
Time frame: Up to 2 years.
Eligibility criteria
Study locations (18)
UC San Diego Moores Cancer Center
La Jolla, California, 92037
University of California, San Francisco (UCSF)
San Francisco, California, 94158
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, 33140
Florida Cancer Specialists, North
St. Petersburg, Florida, 33705
Florida Cancer Specialists, East
West Palm Beach, Florida, 33401
Maryland Oncology Hematology, P.A.
Brandywine, Maryland, 20613
Minnesota Oncology Hematology, P.A.
Maple Grove, Minnesota, 55369
Women's Cancer Care Associates, LLC
Albany, New York, 12208
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
University of Cincinnati Medical Center
Cincinnati, Ohio, 46214
Oncology Associates of Oregon, P.C.
Eugene, Oregon, 97401
Northwest Cancer Specialists, P.C.
Portland, Oregon, 97227
Alliance Cancer Specialists, PC
Doylestown, Pennsylvania, 18901
West Penn Hospital
Pittsburgh, Pennsylvania, 15224
Avera Cancer Institute
Sioux Falls, South Dakota, 57105
Texas Oncology - West Texas
El Paso, Texas, 79902
Texas Oncology - Gulf Coast
The Woodlands, Texas, 77380
Virginia Cancer Specialists, P.C.
Fairfax, Virginia, 22031
References
- 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.(PubMed)