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Anti-metabolites

Gemcitabine + Nab-sirolimus for Soft Tissue Sarcoma

Phase 1

Waitlist Available

Led By Elise Nassif, MD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion; an average of 1 year

Awards & highlights

Study Summary

This trial aims to determine the best dose of two drugs, gemcitabine and nab-sirolimus, that can be safely given together to patients with advanced leiomyosarcomas or

Who is the study for?

This trial is for people with advanced leiomyosarcomas or soft-tissue sarcomas, specifically those with TSC2 or TSC1 loss-of-function mutations or deletions. The full eligibility criteria are not provided, but typically participants must meet certain health standards and may be required to have tried other treatments first.Check my eligibility

What is being tested?

The trial is testing the combination of two drugs: Gemcitabine and Nab-Sirolimus. It aims to find a safe dosage that can be given together to treat patients with specific types of advanced sarcomas.See study design

What are the potential side effects?

While specific side effects are not listed here, common ones for cancer drugs like Gemcitabine and Nab-Sirolimus might include nausea, fatigue, increased risk of infection due to low blood cell counts, liver problems, mouth sores, rash, and diarrhea.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion; an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion; an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Safety and adverse events (AEs)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Gemcitabine + Nab-sirolimusExperimental Treatment2 Interventions

Participants found to be eligible to take part in this study, participants will be assigned to a dose level of gemcitabine and nab-sirolimus based on when participants join this study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Gemcitabine

2017

Completed Phase 3

~2070

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Aadi BioscienceUNKNOWN

M.D. Anderson Cancer CenterLead Sponsor

2,974 Previous Clinical Trials

1,789,462 Total Patients Enrolled

Elise Nassif, MDPrincipal InvestigatorM.D. Anderson Cancer Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants currently being enrolled in this ongoing medical study?

"As per information from clinicaltrials.gov, patient recruitment for this particular trial is currently closed. The trial's initial posting was on July 31, 2024, with the latest update done on March 6, 2024. Despite this trial not accepting new participants at present, there are a total of 469 ongoing trials actively seeking eligible candidates."

Answered by AI

Has the combination of Gemcitabine and Nab-sirolimus received official endorsement from the FDA?

"On a scale of 1 to 3, the safety rating for Gemcitabine + Nab-sirolimus is considered as 1 by our team at Power. This assessment aligns with the nature of this Phase 1 study where there is minimal available data backing its safety and effectiveness."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06308419.

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