Solid Tumors Clinical Trial
Official title:
A Phase 1 Study of Picoplatin in Subjects With Advanced Non-Hematological Malignancies With Emphasis on Cardiac Repolarization
The purpose of this study is to investigate what effects, if any, picoplatin has on the heart rhythm.
Phase 1 and 2 studies have demonstrated that picoplatin, a next-generation platinum analogue
designed to avoid drug resistance, has activity when administered IV in a variety of
cancers. Preclinical and clinical studies indicate that picoplatin may be effective in
platinum refractory or resistant cancer.
Preclinical data in beagle dogs have shown that picoplatin had no effect on cardiovascular
function, including the QT interval. In the cumulative human trial experience, the
cardiovascular serious adverse events that have occurred are consistent with events expected
in patients with advanced malignant disease and do not suggest any propensity toward
drug-related serious ventricular arrhythmias or sudden death.
The purpose of this trial is to conduct a formal study to specifically evaluate the effect
of picoplatin on the QT/QTc interval as measured by the ECG, and to correlate QTcF interval
with plasma total and ultrafilterable platinum concentrations. This study is also being
conducted to ensure the safety of picoplatin with regard to the QT/QTc interval. Patients
who choose to participate in this study will also be given the opportunity to continue to
receive picoplatin until limited by toxicity or disease progression.
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Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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