CompletedPhase 2ACTRN12609000253202

A Multicenter, Open-Label Phase 1b/2 Study to Assess the Safety and Clinical Activity of Intravenous Combretastatin A1 Diphosphate (OXi4503, CA1P) as Monotherapy in Subjects with Primary or Secondary Hepatic Tumour Burden

A Multicenter, Open-Label Phase 1b/2 Study to Assess the Safety and Clinical Activity of Intravenous Combretastatin A1 Diphosphate (OXi4503, CA1P) when treated on Days 1, 8 and 15 of a 28 day treatment cycle in escalating doses as Monotherapy in Subjects with Primary or Secondary Hepatic Tumour Burden until the maximum tolerated dose is determined.

Sponsor

Clinical Network Services (CNS) Pty Ltd

Enrollment

65 participants

Start Date

Mar 15, 2009

Study Type

Interventional

Conditions

Carcinomas with Primary (Hepatocellular carcinoma) or Secondary Hepatic Tumour (carcinoma metastasis) Burden

Summary

to Assess the Safety and Clinical Activity of Intravenous Combretastatin A1 Diphosphate (OXi4503, CA1P)

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This early-phase study tests a drug called OXi4503 (combretastatin) given intravenously for adults (18+) with liver tumours — either primary liver cancer or cancer that has spread to the liver from another site. The drug works by disrupting blood vessels that feed tumours. It is for patients whose cancer has not responded to standard treatments.

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

Subjects will be dosed in 28-day treatment cycles by IV infusion of Combretastatin A1 Diphosphate (OXi4503, CA1P). Subject will have up to 6 cycles of treatment. Dosing will commence at 8.5 mg/m2 and

Subjects will be dosed in 28-day treatment cycles by IV infusion of Combretastatin A1 Diphosphate (OXi4503, CA1P). Subject will have up to 6 cycles of treatment. Dosing will commence at 8.5 mg/m2 and escalate to 11.0, 13.5 and 15.5 mg/m2 and then increase by an additional 25% of the preceding dose level thereafter.

Locations(1)

Australia

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ACTRN12609000253202