Status:
WITHDRAWN
Study to Evaluate the Efficacy and Safety of 90Y-SMT487 in Subjects With Symptomatic Malignant Carcinoid Tumors
Lead Sponsor:
Molecular Insight Pharmaceuticals, Inc.
Conditions:
Malignant Carcinoid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 speci...
Eligibility Criteria
Inclusion
- Life expectancy \> 6 months.
- Subjects must have distant metastases.
- Subjects must be able to discontinue Sandostatin LAR treatment for at least 1 month prior to Day 1/Cycle 1; last dose of Sandostatin LAR must be 60 days or more prior to the first OctreoTher™ dose. For subcutaneous Sandostatin discontinuation should be 12 hours. Subjects taking other long acting somatostatin analogues must discontinue the analogue at least 2 times the dosing interval.
- Upon baseline disease assessment, all subjects must have at least 1 measurable site of disease that either has never been irradiated or if the measurable lesion has been previously irradiated; this same lesion has since demonstrated progression base don the SWOG response criteria.
- Subjects must state or agree with the statement that "I have symptoms from my cancer that bother me." Subjects must have failed to gain complete symptom control despite an optimal attempt at somatostatin therapy in the judgement of their physician.
Exclusion
- Chemotherapy, biologic therapy or other investigational therapy within 4 weeks of Day 1.
- Surgery, hormonal therapy (not including somatostatin analogues) or radiation, within 2 weeks of Day 1.
- Subjects with know brain metastases unless these metastases have been treated and stabilized for at least six months prior to study start.
- Subjects who received high dose OctreoScan therapy or other radiolabelled somatostatin therapy or other systemic radiolabelled therapy (e.g. MIBG) for treatment of metastatic carcinoid.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00696930
Start Date
June 1 2008
Last Update
November 26 2015
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