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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 organ and bone marrow functions are normal.
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My diagnosis is anaplastic thyroid cancer.
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I do not have major stomach or intestine problems.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-Free Survival (PFS)

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
~1600
Paclitaxel
2011
Completed Phase 4
~5380

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,927 Previous Clinical Trials
591,394 Total Patients Enrolled
NovartisIndustry Sponsor
1,607 Previous Clinical Trials
2,709,778 Total Patients Enrolled
Eric Sherman, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
3 Previous Clinical Trials
93 Total Patients Enrolled

Media Library

Paclitaxel (Taxane) Clinical Trial Eligibility Overview. Trial Name: NCT03085056 — Phase < 1
Thyroid Cancer Research Study Groups: Trametinib in Combination With Paclitaxel
Thyroid Cancer Clinical Trial 2023: Paclitaxel Highlights & Side Effects. Trial Name: NCT03085056 — Phase < 1
Paclitaxel (Taxane) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03085056 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What ailment is Trametinib usually utilized to treat?

"Trametinib is an effective treatment option for neoplasm metastasis, Kaposi sarcoma, and advance directives."

Answered by AI

Are there any vacancies left for participants in this experiment?

"This medical research has ceased patient recruitment and was last modified on March 10th 2022. If you're looking for another study, there are 230 trials actively enrolling patients with thyroid cancer while 922 studies related to Trametinib need participants."

Answered by AI

Are there various health facilities in the U.S. that are conducting this medical investigation?

"Seven medical centres are currently enrolling patients in this trial. These include the Memorial Sloan Kettering Westchester (Limited Protocol Activities) facility in Harrison and the Memorial Sloan Kettering Cancer Centre in New york, as well as 5 other sites scattered across America."

Answered by AI

How many participants is the clinical trial currently allowing to join?

"Recruitment for this trial has since been suspended. It was initially posted on March 15th 2017 and modified lastly on the 10th of March 2022. If you seek out other studies, there are currently 230 active clinical trials enrolling individuals who have thyroid cancer, anaplastic carcinoma, or Trametinib-related malignancies."

Answered by AI

Are there any other trials of Trametinib that have been conducted to date?

"Presently, there are 922 active trials for Trametinib and 233 in their final phase. Although many of these experiments are happening in Woolloongabba, Queensland, the exploration of this drug is taking place across 51124 different sites worldwide."

Answered by AI

Who else is applying?

What site did they apply to?
Memorial Sloan Kettering Cancer Center @ Commack (Limited Protocol Activities)
What portion of applicants met pre-screening criteria?
Did not meet criteria

Why did patients apply to this trial?

~1 spots leftby Sep 2024