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Trametinib in Combination With Paclitaxel in the Treatment of Anaplastic Thyroid Cancer | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGEARLY_PHASE1

Trametinib in Combination With Paclitaxel in the Treatment of Anaplastic Thyroid Cancer

A Pilot Study of Trametinib in Combination With Paclitaxel in the Treatment of Anaplastic Thyroid Cancer

NCT03085056•Memorial Sloan Kettering Cancer Center

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Pathologically (histologically or cytologically) proven diagnosis of anaplastic thyroid cancer (a diagnosis that is noted to be consistent with anaplastic thyroid cancer is acceptable).
•Metastatic disease or local-regional disease that is considered not resectable for cure.
•Patients must have measurable disease per RECIST v1.1 criteria, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm with conventional techniques or as ≥10 mm with spiral CT scan, MRI, or calipers by clinical exam
•Age ≥18 years
•ECOG performance status ≤2 (or Karnofsky ≥60)
•Able to swallow and retain orally-administered medication and does not have any clinically significant gastrointestinal abnormalities that may alter absorption, such as malabsorption syndrome or major resection of the stomach or bowels
•No CTCAE v4 grade \>2 neuropathy
•Patients must have normal organ and marrow function as defined below:
•* Absolute neutrophil count (ANC) ≥1.5x10\^9/L
•* Hemoglobin ≥9 g/dL
+7 more criteria

Exclusion Criteria

•Patients who have had chemotherapy or radiotherapy within 7 days of starting treatment.
•Symptomatic or untreated brain metastases, leptomeningeal disease, or spinal cord compression
•History of interstitial lung disease or pneumonitis
•History or current evidence/risk of retinal vein occlusion (RVO) or central serous retinopathy (CSR):
•* History of RVO or CSR, or predisposing factors to RVO or CSR (e.g., uncontrolled glaucoma or ocular hypertension)
•* Visible retinal pathology as assessed by ophthalmic exam that is considered a high risk factor for RVO or CSR such as evidence of new optic disc cupping, evidence of new visual field defects, and intraocular pressure \>21 mm Hg
•History or evidence of cardiovascular risk including any of the following:
•* LVEF\<LLN
•* A QT interval corrected for heart rate using the Bazett's formula QTcB ≥480 msec
•* History or evidence of current clinically significant uncontrolled arrhythmias (exception: patients with controlled atrial fibrillation for \>30 days prior to -enrollment are eligible)
+12 more criteria

Locations (7)

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, United States

Memorial Sloan Kettering Cancer Center @ Commack (Limited Protocol Activities)

Commack, New York, United States

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, United States

Key Dates

Start Date

March 15, 2017

Primary Completion Date

September 1, 2026

Completion Date

September 1, 2026

Last Updated

July 3, 2025

Enrollment

ACTUAL participants

Conditions

Anaplastic Thyroid Cancer

Interventions

Trametinib

DRUG

Paclitaxel

DRUG

Efficacy of Pembrolizumab and Lenvatinib in Patients With Anaplastic Thyroid Cancer

NCT06374602

Anaplastic Thyroid Cancer

View study

ACTIVE_NOT_RECRUITINGPHASE2

Study of Cemiplimab Combined With Dabrafenib and Trametinib in People With Anaplastic Thyroid Cancer

NCT04238624

Anaplastic Thyroid CancerThyroid Cancer+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 3, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Trametinib in Combination With Paclitaxel in the Treatment of Anaplastic Thyroid Cancer

Inclusion Criteria

Exclusion Criteria

Efficacy of Pembrolizumab and Lenvatinib in Patients With Anaplastic Thyroid Cancer

Study of Cemiplimab Combined With Dabrafenib and Trametinib in People With Anaplastic Thyroid Cancer

Study of AIC100 CAR T Cells in Relapsed/Refractory Thyroid Cancer

Abemaciclib in Metastatic or Locally Advanced Anaplastic/Undifferentiated Thyroid Cancer

Inolitazone Dihydrochloride and Paclitaxel in Treating Patients With Advanced Anaplastic Thyroid Cancer

Phase I/II Study of PDR001 in Patients With Advanced Malignancies