Trametinib + Paclitaxel for Thyroid Cancer

Recruiting in Palo Alto (17 mi)

+9 other locations

Overseen by Eric Sherman, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

The purpose of this study is to test the safety and tolerability of this treatment combination of paclitaxel and trametinib. Additionally, this study aims to to find out what effects the combination of paclitaxel and trametinib has on the shrinkage and growth of anaplastic thyroid cancer.

Research Team

Eric Sherman, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

This trial is for adults with anaplastic thyroid cancer that can't be removed by surgery. Participants must be able to take pills, agree to use birth control, and have a certain level of physical ability (ECOG ≤2 or Karnofsky ≥60). They should not have significant nerve damage, gastrointestinal issues, recent chemotherapy or radiotherapy, untreated brain metastases, lung disease history, high cardiovascular risk, active infections like HIV/HBV/HCV or conditions affecting oral medication absorption.

Inclusion Criteria

Women who can have babies must have a negative pregnancy test within 14 days before joining the study.

Agreement to use adequate contraception

Ability to understand and sign a written informed consent document

Exclusion Criteria

I have been diagnosed with HIV, HBV, or HCV.

I do not have any unmanaged ongoing illnesses.

I have a condition that affects my ability to absorb pills.

Treatment Details

Interventions

• Paclitaxel (Taxane)
• Trametinib (MEK Inhibitor)

Trial Overview The study tests the combination of Trametinib and Paclitaxel on anaplastic thyroid cancer. It aims to assess safety and how well this combo works in slowing down tumor growth or causing shrinkage. The effects will be measured according to standard criteria for evaluating the response of solid tumors.

Participant Groups

Group I: Trametinib in Combination With Paclitaxel Experimental Treatment 2 Interventions

Patients will receive paclitaxel 80mg/m\^2 weekly for 3 out of 4 weeks, which is a standard regimen in the treatment of anaplastic thyroid cancer, in combination with trametinib 2mg daily during each 4 week cycle.

Paclitaxel is already approved in Canada for the following indications:

Approved in Canada as Paclitaxel for:

• Ovarian cancer
• Breast cancer
• Non-small cell lung cancer
• Kaposi's sarcoma

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Lisa M. DeAngelis

Memorial Sloan Kettering Cancer Center

Chief Medical Officer since 2021

MD from Columbia University

Selwyn M. Vickers

Memorial Sloan Kettering Cancer Center

Chief Executive Officer since 2022

MD from Johns Hopkins University

Novartis

Industry Sponsor

Trials

1,646

Recruited

2,778,000+

Vasant Narasimhan

Novartis

Chief Executive Officer since 2018

MD from Harvard Medical School, Bachelor's in Biological Sciences from University of Chicago, Master's in Public Policy from John F. Kennedy School of Government

Shreeram Aradhye

Novartis

Chief Medical Officer since 2022

MD from Yale University, MSc in Clinical Epidemiology from University of Pennsylvania