RecruitingPhase 1NCT06308419
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
Sponsor
M.D. Anderson Cancer Center
Enrollment
18 participants
Start Date
Aug 14, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Min Age: 18 Years
Plain Language Summary
Simplified for easier understanding
This early-phase study tests a drug combination — gemcitabine (an established chemotherapy) plus nab-sirolimus (a newer drug that targets a specific cell growth pathway) — in patients with advanced soft tissue sarcomas, particularly leiomyosarcoma or sarcomas with specific gene mutations (TSC1 or TSC2). The goal is to establish safe dosing.
**You may be eligible if...**
- You are 18 years or older
- You have been diagnosed with leiomyosarcoma or another soft tissue sarcoma with TSC1 or TSC2 gene mutations
- Your cancer has spread or cannot be surgically removed, and standard treatments are no longer working
- You have at least one measurable tumor on imaging
- Your liver, kidney, and blood counts are within acceptable ranges
**You may NOT be eligible if...**
- You are pregnant or breastfeeding
- You have active brain metastases (cancer that has spread to the brain) that are not controlled
- You have serious heart problems or an active infection
- You have had gemcitabine within the past 12 months with disease progression while on it
Talk to your doctor to see if this trial is right for you.
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
DRUGGemcitabine
Given by IV
DRUGNab-Sirolimus
Given by IV
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06308419
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