NCT00710697

Cardiac Safety Assessment Study of Picoplatin in Solid Tumors

A Phase 1 Study of Picoplatin in Subjects With Advanced Non-Hematological Malignancies With Emphasis on Cardiac Repolarization

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Poniard Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate what effects, if any, picoplatin has on the heart rhythm.

Detailed description

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.

Conditions

• Solid Tumors

Interventions

Type	Name	Description
DRUG	Picoplatin	IV 150 mg/m2, IV (in the vein) on day 1 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.

Timeline

• Start date: 2008-06-01
• Primary completion: 2009-03-01
• Completion: 2009-07-01
• First posted: 2008-07-04
• Last updated: 2009-09-24

Locations

7 sites across 1 country: United States