Study of Gemcitabine and Nab-Sirolimus for Advanced Leiomyosarcoma or Soft-Tissue Sarcoma

This study is testing a combination of two drugs, gemcitabine and nab-sirolimus, for people with advanced leiomyosarcoma or soft-tissue sarcomas. These cancers must have specific changes (loss-of-function mutations or deletions) in the TSC1 or TSC2 genes. The main goal is to find the safest and most effective dose of these two drugs when given together. Researchers will also look at how well the treatment shrinks tumors and how long people live without their cancer getting worse. You may be able to join if you are 18 or older, have one of these cancers that has spread or cannot be removed by surgery, and standard treatments are no longer working. The current status of this study is unclear.

Study design
This is an interventional study with a planned enrollment of 18 participants. It is designed to find the maximum tolerated dose of the drug combination.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety and side effects will be measured throughout the study completion, which is an average of 1 year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06308419

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
M.D. Anderson Cancer Center
~18 participants
Updated 2026-02-25 on ClinicalTrials.gov
What's tested:GemcitabineNab-Sirolimus

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and adverse events (AEs)
Measured over Through study completion; an average of 1 year
Leiomyosarcoma
Soft-tissue Sarcomas
1 sites across 1 states
Texas1
  • Elise Nassif, MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

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  • Safety and adverse events (AEs)Through study completion; an average of 1 year

    Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0