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Taxane

Trametinib + Paclitaxel for Thyroid Cancer

Phase < 1

Waitlist Available

Led By Eric Sherman, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

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

Must have

Metastatic or local-regional disease considered not resectable for cure

Age ≥18 years

Must not have

Known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) infection

Uncontrolled intercurrent illness

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new combination cancer treatment to see if it is safe and effective against Anaplastic Thyroid Cancer.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include allergic reactions to ingredients in the drugs; nerve damage; digestive problems; risks related to heart health such as vein occlusion; lung issues like pneumonitis; liver function changes due to hepatitis risk factors; and general symptoms like fatigue.

Eligibility Criteria

Inclusion Criteria

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

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My cancer has spread and cannot be surgically removed with the aim of cure.

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I am 18 years old or older.

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I can take care of myself but might not be able to do heavy physical work.

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I can swallow and keep down pills.

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My diagnosis is anaplastic thyroid cancer.

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I do not have major stomach or intestine problems.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I do not have any unmanaged ongoing illnesses.

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I do not have symptoms or untreated issues with brain metastases, leptomeningeal disease, or spinal cord compression.

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I have a history of heart problems or am at risk for them.

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I have not had major surgery in the last 3 weeks.

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I am not using any medications or therapies that are not allowed.

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I have or am at risk for eye conditions like RVO or CSR.

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I have had interstitial lung disease or pneumonitis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Progression-Free Survival (PFS)

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: Trametinib in Combination With PaclitaxelExperimental Treatment2 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Trametinib

2014

Completed Phase 2

~1630

Paclitaxel

2011

Completed Phase 4

~5450