Trametinib in Combination With Paclitaxel in the Treatment of Anaplastic Thyroid Cancer (NCT03085056)
๐ฉบ Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (17 items) and avoid the listed exclusions (23 items).
Location: Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) โ Basking Ridge, New Jersey
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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 โฅ480 msec
- History or evidence of current clinically significant uncontrolled arrhythmias (exception: patients with controlled atrial fibrillation for \>30 days prior to -enrollment are eligible)
- History of acute coronary syndromes (including myocardial infarction and unstable angina), coronary angioplasty, or stenting within 6 months prior to randomization
๐ Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
๐ All Participating Trial Locations (7 Sites)
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) โ Basking Ridge, New Jersey
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) โ Middletown, New Jersey
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) โ Montvale, New Jersey
- Memorial Sloan Kettering Cancer Center @ Commack (Limited Protocol Activities) โ Commack, New York
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) โ Harrison, New York
- Memorial Sloan Kettering Cancer Center โ New York, New York
- Memorial Sloan Kettering Nassau (Limited Protocol Activities) โ Uniondale, New York
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.