NCT00272415

A Study of Intravenous INO-1001 Plus Oral Temozolomide to Evaluate Tolerability, Safety, and Pharmacokinetics in Patients With Melanoma

A Phase Ib, Open-Label, Multicenter Trial of Intravenous INO-1001 Plus Oral Temozolomide to Evaluate the Tolerability, Safety, and Pharmacokinetics in Subjects With Newly-Diagnosed or Recurrent Unresectable Stage III or Stage IV Melanoma

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 39 (estimated)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, open-label, non-randomized, multicenter study in adults, aged eighteen (18) or older, with newly-diagnosed or recurrent unresectable Stage III or Stage IV melanoma. A maximum of 18 subjects will be enrolled in Stage 1 of this study. (Stage 1 completed enrollment in June 2006.) A maximum of 39 subjects will be enrolled in Stage 2 of this study.

Conditions

• Melanoma

Interventions

Type	Name	Description
DRUG	INO-1001	Intravenous repeating dose
DRUG	temozolomide	Oral repeating dose

Timeline

• Start date: 2005-10-01
• First posted: 2006-01-06
• Last updated: 2009-03-11