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mTOR Inhibitor

Drug Combination for Advanced Cancer

Phase 1

Waitlist Available

Led By Filip Janku, MD, PHD

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

ECOG performance status 0-3

Measurable or evaluable disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up after 4, 28 day cycles

Awards & highlights

No Placebo-Only Group

All Individual Drugs Already Approved

Approved for 10 Other Conditions

Summary

This trial is investigating a combination of drugs to treat advanced cancer, and the safety of the drug combination. Up to 249 patients will take part at MD Anderson.

Who is the study for?

This trial is for adults with advanced cancers that haven't responded to standard treatments or have no standard treatment improving survival by three months. Participants need measurable disease, must not have had recent chemotherapy, and should have proper organ function. They must use effective contraception and cannot be pregnant or nursing.

What is being tested?

Researchers are testing the highest dose of Vorinostat combined with either Sirolimus, Everolimus, or Temsirolimus that patients can tolerate without severe side effects. These drugs aim to slow cancer growth by targeting specific proteins in cancer cells.

What are the potential side effects?

Potential side effects include fatigue, nausea, blood count changes affecting immunity and clotting, liver issues signaled by enzyme changes in blood tests, mouth sores, rash, diarrhea and possibly lung problems due to inflammation.

Eligibility Criteria

Inclusion Criteria

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

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I can care for myself but may not be able to do heavy physical work.

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My cancer can be measured or seen on tests.

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My advanced cancer has not improved with standard treatments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ after 4, 28 day cycles

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~after 4, 28 day cycles

This trial's timeline: 3 weeks for screening, Varies for treatment, and after 4, 28 day cycles for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Maximum Tolerated Dose (MTD)

Secondary study objectives

Tumor Response

Awards & Highlights

No Placebo-Only Group

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

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Arm C: Vorinostat + TemsirolimusExperimental Treatment2 Interventions

Escalation and Expansion Phase: Vorinostat dose 300 mg by mouth on Days 7 - 28. Rest of cycles: 300 mg by mouth on Days 1 - 28. Escalation Phase: Temsirolimus starting dose 12.5 mg by vein on Days 1, 8, 15, 22. Expansion Phase: MTD from Escalation Phase.

Group II: Arm B: Vorinostat + EverolimusExperimental Treatment2 Interventions

Escalation and Expansion Phase: Vorinostat dose 300 mg by mouth on Days 7 - 28. Rest of cycles: 300 mg by mouth on Days 1 - 28. Escalation Phase: Everolimus starting dose 5 mg by mouth on Days 1 - 28. Expansion Phase: MTD from Escalation Phase.

Group III: Arm A: Vorinostat + SirolimusExperimental Treatment2 Interventions

Escalation Phase: Vorinostat starting dose 100 mg by mouth on Days 7 - 28 of Cycle 1; For all other cycles, dose of 100 mg Days 1-28. Expansion Phase starting dose: MTD from Escalation Phase. Escalation Phase: Sirolimus starting dose1 mg by mouth on Days 1 - 28. Expansion Phase starting dose: MTD from Escalation Phase.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sirolimus

FDA approved

Everolimus

FDA approved

Temsirolimus

FDA approved

Vorinostat

FDA approved