drugset / Trial / NCT00747825
Phase I Safety and Dosimetry Study in Patients With Confirmed Metastatic Melanoma
Non-randomizedSingle-groupOpen-labelDiagnostic
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.
Timeline
- Start
- 2009-12
- Primary completion
- 2011-09
- Completion
- 2011-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 131-I-MIP-1145 | Small molecule | 148 mbq | Intravenous |
| Subject | 131-I-MIP-1145 | Small molecule | 222 mbq | Intravenous |