Who is sponsoring NCT00395070?

NCT00395070 is sponsored by Vical.

What condition does NCT00395070 study?

NCT00395070 studies Metastatic Melanoma.

What drugs are being tested in NCT00395070?

Interventions: Allovectin-7®, Dacarbazine (DTIC), Temozolomide (TMZ).

What is the status of NCT00395070?

NCT00395070 is currently COMPLETED.

Last reviewed 2013-09-11 · How we verify

A Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of Treatment With 2 mg Intralesional Allovectin-7® Compared to Dacarbazine (DTIC) or Temozolomide (TMZ) in Subjects With Recurrent Metastatic Melanoma

NCT00395070 Phase 3 COMPLETED

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.

Details

Lead sponsor	Vical
Phase	Phase 3
Status	COMPLETED
Enrolment	390
Start date	2006-10
Completion	2013-07

Conditions

Metastatic Melanoma

Interventions

Allovectin-7®
Dacarbazine (DTIC)
Temozolomide (TMZ)

Primary outcomes

To compare the overall response rate at ≥24 weeks after randomization in the Allovectin-7® arm versus the control (DTIC/TMZ) arm. — After all 375 subjects are enrolled

Countries

United States, Belgium, Brazil, Canada, France, Germany, Israel, Italy, Netherlands, Poland, Russia, Spain, Switzerland, Turkey (Türkiye)