A Study to Assess APO866 for the Treatment of Advanced Melanoma
Status:
Completed
Trial end date:
2009-03-01
Target enrollment:
Participant gender:
Summary
This phase II study is designed to determine the efficacy and safety of APO866 for the
treatment of patients with advanced cutaneous melanoma. APO866 has shown to induce growth
inhibition in cultures of human melanoma cells as well as in animal models with
subcutaneously implanted melanoma tumors. APO866 was considered to be safe and well tolerated
in a phase I study that treated 24 patients with advanced cancer. In that study one of the
two patients with advanced melanoma had a stable disease for 5 months with size reduction of
some lesions. APO866 is administered by intravenous infusion continuously for 96 hours that
is repeated every 4 weeks. Patients will receive 3 cycles of treatment and the primary
efficacy endpoint will be assessed at Week 16. Patients will be follow-up for 12 months.