Study to Evaluate the Efficacy and Safety of 90Y-SMT487 in Subjects With Symptomatic Malignant Carcinoid Tumors
Status:
Withdrawn
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
Subjects will be screened to determine OctreoScan® uptake. And upon meeting the eligibility
criteria, 90 subjects will complete a symptom assessment scale at baseline and throughout the
study at specific time points. Actual treatment will consist of three six-week cycles of a
fixed total dose of 13.3 GBq (360 mCi) of 90Y-SMT487. The total dose will be divided into
three equal doses and administered as a single activity of 4.4 GBq (120 mCi) of 90Y-SMT487
once every six weeks for three cycles. An amino acid infusion will be administered along with
each dose. Long-term follow up will occur at 6 and 12 months after Day 1/ Cycle 1. Survival
will be assessed every six months.