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)

MD Anderson Cancer Center

Houston, Texas, United States

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NCT06308419


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