drugset / Trial / NCT00395070

A Phase 3 Pivotal Trial Comparing Allovectin-7® Alone vs Chemotherapy Alone in Patients With Stage 3 or Stage 4 Melanoma

NCT00395070

Phase 3 Completed 390 enrolled Vical
RandomizedParallel-groupSingle-blindTreatment

Summary

To compare the safety and efficacy of Allovectin-7® versus Dacarbazine (DTIC)or Temozolomide (TMZ) in subjects with recurrent stage 3 or stage 4 melanoma.

Timeline

Start
2006-10
Primary completion
2012-03
Completion
2013-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Allovectin-7® Other / unclassified 2 mg Other
Comparator Dacarbazine Small molecule 1000 mg/m2 Intravenous
Comparator Temozolomide Small molecule 150 mg/m2 Oral
Comparator Temozolomide Small molecule 200 mg/m2 Oral

Indications