NCT00696930

Study to Evaluate the Efficacy and Safety of 90Y-SMT487 in Subjects With Symptomatic Malignant Carcinoid Tumors

A Phase II Open-label Multi-center Study to Evaluate the Efficacy and Safety of 90Y-SMT487 in Subjects With Symptomatic Malignant Carcinoid Tumors

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Molecular Insight Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Malignant Carcinoid Tumor

Interventions

Type	Name	Description
DRUG	90Y-SMT487

Timeline

• Start date: 2008-06-01
• Primary completion: 2008-06-01
• First posted: 2008-06-13
• Last updated: 2015-11-26