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Anti-diabetic drug

Temsirolimus + Metformin for Advanced Cancer

Phase 1

Waitlist Available

Led By Aung Naing, 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

Eastern Cooperative Oncology Group (ECOG) performance status =< 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10 weeks

Awards & highlights

Study Summary

This trial is testing temsirolimus and metformin hydrochloride to see if they can effectively treat cancer that has spread to other parts of the body. Temsirolimus works by blocking enzymes needed for cell growth, while metformin hydrochloride is a drug used to treat diabetes that may also prevent or slow the growth of cancers. Together, these two drugs may be able to kill more tumor cells.

Who is the study for?

This trial is for adults with advanced or metastatic cancer that's resistant to standard treatments, relapsed, or has no effective standard therapy. Participants must have stable vital signs and organ function, not be pregnant or breastfeeding, agree to use contraception, and be able to take oral medication. They should be recovered from previous therapies and not on certain drugs affecting liver enzymes.Check my eligibility

What is being tested?

The study tests the combination of temsirolimus (an enzyme blocker) and metformin hydrochloride (a diabetes drug potentially slowing cancer growth) in patients with advanced cancers. It aims to determine the safest doses while observing how well these drugs work together against tumor cells.See study design

What are the potential side effects?

Potential side effects include reactions related to cell growth inhibition by temsirolimus and digestive issues commonly associated with metformin. Specific side effects will depend on individual patient responses but may involve fatigue, nausea, changes in blood counts or liver enzymes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am fully active and can carry on all pre-disease activities without restriction.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~10 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 weeks for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Maximum Tolerated Dose (MTD) of Temsirolimus and Metformin

Secondary outcome measures

Clinical Tumor Response

Trial Design

1Treatment groups

Experimental Treatment

Group I: Temsirolimus + MetforminExperimental Treatment2 Interventions

Starting dose of Temsirolimus 25 mg by vein weekly. Metformin titrated over 3 weeks at 500 mg by mouth daily. Four weeks of treatment constitute 1 cycle. Cycle one (1) however, will be 6 weeks long to allow for metformin titration.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Temsirolimus

2008

Completed Phase 2

~1940

Metformin

2006

Completed Phase 4

~2430