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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
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.
Premiere Oncology of Arizona
Scottsdale, Arizona, United States
Moores UCSD Cancer Center
La Jolla, California, United States
Premiere Oncology
Santa Monica, California, United States
Georgia Cancer Specialists
Atlanta, Georgia, United States
ECG interval change
Time frame: 24 hours
Safety/Efficacy
Time frame: 24 hours
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UNM Cancer Center
Albuquerque, New Mexico, United States
Swedish Cancer Institute
Seattle, Washington, United States
Northwest Medical Specialities
Tacoma, Washington, United States