NCT00412828

A Phase I/II Study of CR011-vcMMAE in Subjects With Unresectable Stage III or Stage IV Melanoma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 117 (actual)
• Sponsor: CuraGen Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the safety, tolerability and pharmacokinetics of CR011-vcMMAE in patients who have unresectable stage III or stage IV melanoma and have failed no more than 1 line of prior cytotoxic therapy. CR011-vcMMAE will be administered intravenously (IV) once every 3 weeks at escalating doses until the maximum tolerated dose (MTD) is reached. Once the MTD is defined, 18-32 patients will be enrolled to further evaluate the safety and efficacy of CR011-vcMMAE at this dose level. Additional dosing schedules of CR011-vcMMAE will also be explored.

Conditions

• Unresectable Stage III or Stage IV Melanoma

Interventions

Type	Name	Description
DRUG	CR011-vcMMAE	administered as an intravenous infusion of 250 mL over 90 min

Timeline

• Start date: 2006-06-01
• Primary completion: 2010-12-01
• Completion: 2011-05-01
• First posted: 2006-12-19
• Last updated: 2015-02-19

Locations

4 sites across 1 country: United States