Back to resultsStudy to Evaluate the Efficacy and Safety of 90Y-SMT487 in Subjects With Symptomatic Malignant Carcinoid Tumors
Primary Purpose
Malignant Carcinoid Tumor
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
90Y-SMT487
Sponsored by
About this trial
This is an interventional treatment trial for Malignant Carcinoid Tumor focused on measuring Malignant Carcinoid Tumors
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00696930
First Posted
June 11, 2008
Last Updated
November 24, 2015
Sponsor
Molecular Insight Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00696930
Brief Title
Study to Evaluate the Efficacy and Safety of 90Y-SMT487 in Subjects With Symptomatic Malignant Carcinoid Tumors
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Withdrawn
Study Start Date
June 2008 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Molecular Insight Pharmaceuticals, Inc.
4. Oversight
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Carcinoid Tumor
Keywords
Malignant Carcinoid Tumors
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
90Y-SMT487
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
12. IPD Sharing Statement
Learn more about this trial
Study to Evaluate the Efficacy and Safety of 90Y-SMT487 in Subjects With Symptomatic Malignant Carcinoid Tumors
We'll reach out to this number within 24 hrs