Not Yet RecruitingPhase 2ACTRN12606000330549

An Open Label, Multi Centre, Phase II Study to Evaluate the Safety and Efficacy of Coramsine Injection in Patients with Melanoma


Sponsor

Solbec Pharmaceuticals Ltd

Enrollment

56 participants

Start Date

Oct 1, 2006

Study Type

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

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing an experimental injection called Coramsine for adults aged 18 and over with advanced melanoma (stage III that cannot be removed by surgery, or stage IV). Participants must have measurable tumour(s) and be in reasonably good health overall.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Coramsine Injection. 1.5mg/kg infused over 4 hours, daily for 5 days. Six cycles.

Coramsine Injection. 1.5mg/kg infused over 4 hours, daily for 5 days. Six cycles.


Locations(1)

Australia

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