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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

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Minor Study sites: 16 to 18v7
  2. Minor Study sites: 14 to 16v6
  3. Minor Study sites: 10 to 14
    • Eligibility criteria expanded, about 52 words
    • Study title expanded, about 2 words
    v5
  4. Minor Study sites: 2 to 10v4
  5. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 2
    • Start date changed from estimate of Dec 31, 2024 to Dec 12, 2024
    v3
  6. Notable Enrollment target: 120 to 40v2 Show 6 more changesShow less
    • Start date: Sep 30, 2024 to Dec 31, 2024
    • Eligibility criteria expanded, about 31 words
    • Secondary endpoints: 5 to 6
    • Study description shortened, about 12 words
    • Study arms: 3 to 1
    • Study title shortened, about 1 word
  7. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06463028
Lead Sponsor Faeth Therapeutics
Collaborators: GOG Foundation
Conditions
(from sponsor)
Endometrial Cancer
Related terms Carcinoma, Endometrioid, Endometrial Neoplasms, Genital Diseases, Hereditary Sensory and Autonomic Neuropathies
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov