The purpose of the study is to evaluate the efficacy of treatment with abemaciclib in patients with anaplastic thyroid/undifferentiated thyroid
Name: Abemaciclib
Description: Overall response defined as either complete response or partial response assessed using RECIST v1.1 criteria. This measure will be reported as a number without dispersion. RECIST v1.1 criteria: Evaluation of Target Lesions Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, no appearance of new lesions. Evaluation of Non-Target Lesions Complete Response (CR): Disappearance of all non-target lesions Incomplete Response/Stable Disease (SD): Persistence of one or more non-target lesion(s) Progressive Disease (PD): Appearance of one or more new lesions
Measure: Overall response (OR) Time: 8 (+/-4) weeks from start of treatmentDescription: Overall survival defined as duration of time from start of treatment to death from any cause. This will be reported as median survival time with interquartile range
Measure: Overall survival (OS) Time: 3 yearsDescription: Progression-free survival (PFS) defined as the duration of time from start of treatment to time of progression or death from any cause. This will be reported as median time with interquartile range.
Measure: Progression-free survival (PFS) Time: 3 yearsAllocation: N/A
Single Group Assignment
There is one SNP
This will be reported as median time with interquartile range.. Inclusion Criteria: 1. Histologically or cytologically confirmed diagnosis of anaplastic thyroid cancer or undifferentiated thyroid cancer that does not have a known BRAF V600E positive on tissue/blood testing. --- V600E ---
BRAF V600E positive patients are eligible if they have previously received FDA approved therapy for this genetic abnormality and progressed or become intolerant. --- V600E ---
Inclusion Criteria: 1. Histologically or cytologically confirmed diagnosis of anaplastic thyroid cancer or undifferentiated thyroid cancer that does not have a known BRAF V600E positive on tissue/blood testing. --- V600E ---