An Open Label, Multi Centre, Phase II Study to Evaluate the Safety and Efficacy of Coramsine Injection in Patients with Melanoma
Solbec Pharmaceuticals Ltd
56 participants
Oct 1, 2006
Interventional
Conditions
Summary
Melanoma is the least common but the most life-threatening of all skin cancers, accounting for only about 4% of all cases but causing 79% of skin cancer deaths. Whilst early stage melanoma can be successfully treated by surgical removal, few effective treatments exist for melanoma which has progressed to a later stage. The purpose of this study is to investigate the effect of Coramsine® in patients with late stage melanoma as well as evaluate the safety and tolerability of the drug. Also, the effect of Coramsine on Progression Free Survival will be assessed (this is defined as the length of time during and after treatment that the cancer does not grow and includes the amount of time patients have experienced a complete response or a partial response, as well as the amount of time patients have experienced stable disease).
Eligibility
Plain Language Summary
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Interventions
Coramsine Injection. 1.5mg/kg infused over 4 hours, daily for 5 days. Six cycles.
Locations(1)
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ACTRN12606000330549