NCT00747825

Phase I Safety and Dosimetry Study in Patients With Confirmed Metastatic Melanoma

A Phase I Study Evaluating the Safety, Pharmacokinetics, Tissue Distribution, and Determination of Radiation Dosimetry for 131-I-MIP-1145

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Molecular Insight Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, single dose study for patients 18 years of age or older with confirmed metastatic melanoma. Up to 12 patients will be enrolled and all will receive an injection of approximately 4.0 to 6.0 mCi (148-222 MBq) of 131-I-MIP-1145 administered via IV injection. The study will consist of a single dosing day followed by a 7-day assessment period and 21-day follow-up period. The total duration of the study from screening to final follow-up visit is approximately 60 days.

Conditions

• Metastatic Melanoma

Interventions

Type	Name	Description
DRUG	131-I-MIP-1145	IV injection between 4.0 to 6.0 mCi (148-222 MBq) of 131-I-MIP-1145

Timeline

• Start date: 2009-12-01
• Primary completion: 2011-09-01
• Completion: 2011-09-01
• First posted: 2008-09-05
• Last updated: 2011-10-12

Locations

1 site across 1 country: United States