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

Part of paid clinical trials in La Jolla, California.

Sponsor
Faeth Therapeutics
Study ID
NCT06463028
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sapanisertib — DRUG
    Oral
  • Serabelisib — DRUG
    Oral
  • Paclitaxel — DRUG
    Infusion

Study Details

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.

Key Dates

Start date
Dec 12, 2024
Status verified
Dec 2025
Primary completion
Sep 30, 2028
Completion
Sep 30, 2029

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: sapanisertib and serabelisib (PIKTOR) with paclitaxel
    Subjects will receive doses of sapanisertib and serabelisib (PIKTOR) administered orally and paclitaxel administered intravenously.

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: Up to 2 years ]

Central Contacts

Locations (18)

FacilityCityStateZIPSite coordinators
UC San Diego Moores Cancer CenterLa JollaCalifornia92037-
University of California, San Francisco (UCSF)San FranciscoCalifornia94158-
Mount Sinai Comprehensive Cancer CenterMiami BeachFlorida33140-
Florida Cancer Specialists, NorthSt. PetersburgFlorida33705-
Florida Cancer Specialists, EastWest Palm BeachFlorida33401-
Maryland Oncology Hematology, P.A.BrandywineMaryland20613-
Minnesota Oncology Hematology, P.A.Maple GroveMinnesota55369-
Women's Cancer Care Associates, LLCAlbanyNew York12208-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
University of Cincinnati Medical CenterCincinnatiOhio46214-
Oncology Associates of Oregon, P.C.EugeneOregon97401-
Northwest Cancer Specialists, P.C.PortlandOregon97227-
Alliance Cancer Specialists, PCDoylestownPennsylvania18901-
West Penn HospitalPittsburghPennsylvania15224-
Avera Cancer InstituteSioux FallsSouth Dakota57105-
Texas Oncology - West TexasEl PasoTexas79902-
Texas Oncology - Gulf CoastThe WoodlandsTexas77380-
Virginia Cancer Specialists, P.C.FairfaxVirginia22031-

Find similar trials in La Jolla, CA

By condition
Endometrial cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
UC San Diego Moores Cancer Center· La Jolla, CAUniversity of California, San Francisco (UCSF)· San Francisco, CAMount Sinai Comprehensive Cancer Center· Miami Beach, FLFlorida Cancer Specialists, North· St. Petersburg, FLFlorida Cancer Specialists, East· West Palm Beach, FLMaryland Oncology Hematology, P.A.· Brandywine, MD

Related Studies