Gemcitabine + Nab-Sirolimus for Sarcoma

Phase 1

Recruiting

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

No Placebo-Only Group

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety and adverse events (AEs)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~1920

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