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
M.D. Anderson Cancer Center
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.
Description
Primary Objectives: * To estimate the Maximum Tolerated Dose (MTD) of gemcitabine and nab-sirolimus combination in patients with advanced leiomyosarcomas or advanced soft-tissue sarcomas with TSC2 or TSC1 loss-of-function mutations or deletions. Secondary Objectives * To estimate the rate of toxicity in the combination of gemcitabine and nab-sirolimus in participants with advanced leiomyosarcomas or advanced soft-tissue sarcomas with TSC2 or TSC1 loss-of-function mutations or deletions. * To describe anti-tumor activity (ORR) by radiographic evaluation (RECIST 1.1) * To describe Progression…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Patients must have histologically confirmed leiomyosarcoma or sarcoma with TSC2 or TSC1 loss-of-function mutations or deletions based on standard-of-care genomic testing. 2. Sarcoma that is metastatic or unresectable and for which standard curative measures do not exist or are no longer effective. One prior standard systemic therapy is required for leiomyosarcoma (LMS) Patients. 3. Prior gemcitabine-based chemotherapy is allowed if the last dose of gemcitabine was given more than 12 months prior to the first dose of treatment on trial, there was no progression of diseas…
Interventions
- DrugGemcitabine
Given by IV
- DrugNab-Sirolimus
Given by IV
Location
- MD Anderson Cancer CenterHouston, Texas