drugset / Trial / NCT00272415

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

NCT00272415 ↗

Phase 1 Terminated 39 enrolled Genentech, Inc.
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2005-10
Primary completion
—
Completion
—

Drugs

EvaluationDrugModalityDoseRoute
Subject INO-1001 Unknown — Intravenous
Subject Temozolomide Small molecule — Oral

Indications