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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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
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
~1550
Paclitaxel
2011
Completed Phase 4
~5380
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,940 Previous Clinical Trials
588,879 Total Patients Enrolled
NovartisIndustry Sponsor
1,614 Previous Clinical Trials
2,721,339 Total Patients Enrolled
Eric Sherman, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
3 Previous Clinical Trials
93 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.Women who can have babies must have a negative pregnancy test within 14 days before joining the study.I have not had chemotherapy or radiotherapy in the last 7 days.I do not have symptoms or untreated issues with brain metastases, leptomeningeal disease, or spinal cord compression.I have a history of heart problems or am at risk for them.I have not had major surgery in the last 3 weeks.I am not using any medications or therapies that are not allowed.My cancer has spread and cannot be surgically removed with the aim of cure.I am 18 years old or older.I can take care of myself but might not be able to do heavy physical work.I can swallow and keep down pills.My organ and bone marrow functions are normal.My diagnosis is anaplastic thyroid cancer.You have a disease that can be measured using specific criteria.I do not have major stomach or intestine problems.You do not have severe neuropathy based on a specific grading system.I have or am at risk for eye conditions like RVO or CSR.I have had interstitial lung disease or pneumonitis.You have had a bad reaction to taxanes, trametinib, or similar drugs, or to the ingredients in the study drug.
Research Study Groups:
This trial has the following groups:- Group 1: Trametinib in Combination With Paclitaxel
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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