Protocol EC-FV-05: An Open-label, Multi-center, Extension Study of EC145 Administered Weeks 1 and 3 of a 4-Week Cycle in Subjects Enrolled in a Previous Study With EC145
This extension protocol is for those subjects that have completed the allowed duration of
participation in an Endocyte-sponsored clinical trial of EC145 and have continuing evidence
of clinical benefit (stable disease or better) at the time that they completed participation
in that study.
Following confirmation of eligibility, subjects will receive intravenously-administered
EC145 at a dose of 2.5 mg. Dosing will occur on Monday, Wednesday, and Friday of weeks 1 and
3 of each 4-week cycle. No therapy will be administered during weeks 2 and 4. Subjects
randomized to non-EC145-containing treatment arms of EC145 trials are not eligible for this
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Summary of the frequency of treatment-emergent adverse events and serious adverse events (by CTCAE v3.0 preferred term and system organ class). Summary of laboratory test values with descriptive statistics and analyzed for abnormal changes from baseline.
Binh Nguyen, MD
United States: Food and Drug Administration
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