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Sponsored by: |
Molecular Insight Pharmaceuticals, Inc. |
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Information provided by: | Molecular Insight Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT00696930 |
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.
Condition | Intervention | Phase |
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Malignant Carcinoid Tumor |
Drug: 90Y-SMT487 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Safety/Efficacy Study |
Official Title: | A Phase II Open-Label Multi-Center Study to Evaluate the Efficacy and Safety of 90Y-SMT487 in Subjects With Symptomatic Malignant Carcinoid Tumors |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | ( Molecular Insight Pharmaceuticals, Inc. ) |
Study ID Numbers: | CSMT 487A 2202 |
Study First Received: | June 11, 2008 |
Last Updated: | June 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00696930 |
Health Authority: | United States: Food and Drug Administration |
Malignant Carcinoid Tumors |
Carcinoid tumor Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neuroepithelioma Carcinoid Tumor |
Adenocarcinoma Neoplasms, Glandular and Epithelial Carcinoma Neuroendocrine Tumors |
Neoplasms Neoplasms by Histologic Type Neoplasms, Nerve Tissue |