A Phase I Trial of Combination Gemcitabine and Nab-Sirolimus in Advanced Leiomyosarcomas or Advanced Soft-Tissue Sarcomas With TSC2 or TSC1 Loss-of-function Mutations or Deletions

StatusActive, Not Recruiting
PhasePhase 1
Started

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Record History

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  1. Enrollment closed, study ongoing
    • Eligibility criteria expanded, about 7 words
    • Study description expanded, about 9 words
    • Site details revised
  2. Trial status: Active, Not Recruiting to Recruiting
    • Site details revised
    v7
  3. Enrollment target: 12 to 18
    • Eligibility criteria shortened, about 1 word
    v6
  4. Trial status: Recruiting to Active, Not Recruiting
    • Eligibility criteria expanded, about 31 words
    • Site details revised
    v5
  5. Eligibility criteria shortened, about 11 wordsv4
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  1. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jul 31, 2024 to Aug 14, 2024
    • Site details revised
    v3
  2. Site contact updatedv2
  1. Study First Submitted
  • 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.
M.D. Anderson Cancer Center
1,231 trials monitored
See 85 trials at risk
Sarcoma
1,027 trials monitored
See 70 trials at risk
To find a recommended dose of gemcitabine and nab-sirolimus that can be given in combination to participants with advanced leiomyosarcomas or soft-tissue sarcomas.
Trial Details
NCT Number NCT06308419
Lead Sponsor M.D. Anderson Cancer Center
Collaborators: Aadi Bioscience
Conditions
(from sponsor)		 Leiomyosarcoma, Soft-tissue Sarcomas
Related terms Leiomyosarcoma, Sarcoma
Enrollment 18 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov