The purpose of the study was to provide access to continued treatment for those who participated in other Astellas sponsored ASP2215 trials that completed the primary analysis and, had the potential to continue to derive clinical benefit from the treatment with ASP2215, and who did not meet any of the study discontinuation criteria in the present study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
oral tablet
Site US10005
Phoenix, Arizona, United States
Site US10003
Baltimore, Maryland, United States
Site US10006
New York, New York, United States
Site US10007
New York, New York, United States
Number of Participants With Adverse Events
AE was defined as any untoward medical occurrence in a participant administered a study drug or has undergone study procedures and which did not necessarily have a causal relationship with this treatment. An abnormality identified during a medical test (e.g., laboratory parameter, vital sign, Electrocardiography (ECG) data, and physical exam) was defined as an AE only if the abnormality induces clinical signs or symptoms or requires active intervention or requires interruption or discontinuation of study medication or the abnormality or investigational value is clinically significant in the opinion of the investigator.
Time frame: From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 811.0 days, minimum of 43 days and maximum of 1067 days)
Eastern Cooperative Oncology Group (ECOG) Performance Status at End Of Treattment Visit (EOT)
ECOG performance status was used to assess participants disease progression, and ability to carry out the daily living activities. The participants were graded on a scale of 0 to 5 where 0 = fully active, able to carry on all predisease performance without restriction; 1 = restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work; 2 = ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours; 3 = capable of only limited self-care,confined to bed or chair more than 50% of waking hours; 4 = completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; 5 = Dead. Number of participants with ECOG performance status was reported.
Time frame: EOT Visit (30 days post-last dose, maximum treatement duration of 1067 days)
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Site US10001
Cleveland, Ohio, United States
Site US10004
Hershey, Pennsylvania, United States
Site US10008
Philadelphia, Pennsylvania, United States