A Phase 1 Study of Picoplatin in Subjects With Advanced Non-Hematological Malignancies With Emphasis on Cardiac Repolarization
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.
Interventional
Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
ECG interval change
24 hours
Yes
Robert Earhart, MD, PhD
Study Director
Poniard Pharmaceuticals
United States: Food and Drug Administration
0701
NCT00710697
June 2008
July 2009
Name | Location |
---|---|
Swedish Cancer Institute | Seattle, Washington 98104 |
Georgia Cancer Specialists | Decatur, Georgia 30033 |
Moores UCSD Cancer Center | La Jolla, California 92093-0658 |
Premiere Oncology | Santa Monica, California 90404 |
Premiere Oncology of Arizona | Scottsdale, Arizona 85260 |
UNM Cancer Center | Albuquerque, New Mexico 87106 |
Northwest Medical Specialities | Tacoma, Washington 98405 |