Trametinib in Combination With Paclitaxel in the Treatment of Anaplastic Thyroid Cancer (NCT03085056) | Clinical Trial Compass
Active — Not RecruitingEarly Phase 1
Trametinib in Combination With Paclitaxel in the Treatment of Anaplastic Thyroid Cancer
United States13 participantsStarted 2017-03-15
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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
* Platelets ≥100x10\^9/L
* Serum bilirubin ≤1.5x institutional upper limit of normal (ULN) (Unless Gilbert's Disease in which case total bilirubin ≤3x institutional ULN)
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5x institutional ULN (≤5x institutional ULN if there is liver metastasis)
* Serum creatinine ≤1.5 mg/dL OR calculate…