RecruitingPhase 1ACTRN12612000908831

A Phase I study of 4-(N-(S-penicillaminylacetyl)amino) phenylarsonous acid (PENAO) given as a continuous intravenous infusion, to patients with advanced solid tumours

Sponsor

University of NSW

Enrollment

35 participants

Start Date

Jul 17, 2012

Study Type

Interventional

Conditions

Patients with advanced solid tumours

Summary

The main aim of the study is to work out the safest dose of PENAO to give to patients. PENAO is an organoarsenic which means it is related to arsenic. There are other drugs in this class which are used to treat different forms of cancer. In this research study patients will be given a new drug, PENAO, for the first time. This drug has been previously safely tested in animals but has not been tested before in humans. Because of this, it is unknown what the most effective and safe dosage level should be. Secondly, the study aims to monitor patients to collect more information about how the drug is broken down by the body and do scans to observe whether the drug has an effect on tumours. To date, this drug has been shown to slow or stop the growth of many different types of tumours when grown in mice. PENAO is an experimental drug. This means that it is not an approved treatment for cancer in Australia or other parts of the world. This study drug was developed by a group of researchers at the University of NSW as an anti-cancer agent. This research and the clinical study are funded by the Cancer Institute of NSW.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This is a first-in-human study of a new experimental drug called PENAO, which is an arsenic-based compound developed to kill cancer cells. PENAO has been shown to slow tumor growth in mice with many types of cancer. This Phase I trial aims to find the safest dose in humans and to study how the body breaks down the drug. It is open to patients with advanced solid tumors that have not responded to standard treatments. You may be eligible if: - You are 18 years or older - You have an advanced solid tumor that is no longer responding to standard treatment or for which no standard treatment exists - Your general health is good (ECOG 0 or 1) - You are expected to live more than 3 months - Your kidney, heart, liver, and blood counts meet the study requirements You may NOT be eligible if: - You are currently on blood-thinning medications - You have HIV infection or active hepatitis B - You have known brain metastases - You have significant nerve damage (peripheral neuropathy above Grade I) - You are pregnant or breastfeeding - You have a history of allergic reactions to arsenic compounds Talk to your doctor about whether this trial might be right for you.

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

4-(N-(S-penicillaminylacetyl)amino) phenylarsonous acid (PENAO) PENAO will be administered as a continuous intravenous infusion, using a centrally placed infusion line and a portable pump. Patient

4-(N-(S-penicillaminylacetyl)amino) phenylarsonous acid (PENAO) PENAO will be administered as a continuous intravenous infusion, using a centrally placed infusion line and a portable pump. Patients will be enrolled and assessed in groups of 3 patients per cohort. If no defined severe toxicity is observed, then 3 new patients will be treated at the next higher dose level. If some defined severe toxicity is observed, the cohort may be expanded to 6 patients or recognised as the Maximum Active Drug Level. The starting dose of PENAO will be 2.0 mg/m2/day over 4 days (96 hours) in every 21 day cycle. Subsequent cohorts/groups of patients will receive the same daily dose over periods of 7 days, 14 days and 21 days. Once the feasibility of a 21 day infusion is determined, this schedule will be maintained and the daily dose will then be increased between cohorts. Subsequently daily dose increases are predefined in the protocol, and range between 30-40% of the previous safe dose.

Locations(1)

VIC, Australia

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ACTRN12612000908831