A Phase II Study of PI-88 With Dacarbazine in Patients With Metastatic Melanoma

NCT00130442 Phase 2 COMPLETED Results posted

The aim of the study is to compare the safety and effectiveness of a new drug called PI-88, when used in combination with an approved chemotherapy drug called dacarbazine, in the treatment of metastatic melanoma. PI-88 blocks new blood vessel growth in tumours (starves it of nutrients) and dacarbazine stops the cancer cells from growing. The results from this study will be analysed to see if it is worthwhile for the two drugs to be tested in future studies involving larger numbers of melanoma patients.

Details

Lead sponsor	Cellxpert Biotechnology Corp.
Phase	Phase 2
Status	COMPLETED
Enrolment	134
Start date	2005-06
Completion	2010-10

Conditions

• Melanoma

Interventions

• PI-88 and dacarbazine
• dacarbazine or DTIC

Primary outcomes

• Non-progression Rate After Six Cycles — In week 3 of every second cycle (each cycle was 21 days) for all subjects enrolled, up to the end of cycle 6 (About 5 months after randomization)
  The Proportion of Patients With Objective Response or Stable Disease (Non-progression Rate) after six treatment cycles

Countries

United States, Australia