Cardiac Safety Assessment Study of Picoplatin in Solid Tumors
Recruitment status was Active, not recruiting
The purpose of this study is to investigate what effects, if any, picoplatin has on the heart rhythm.
|Study Design:||Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 1 Study of Picoplatin in Subjects With Advanced Non-Hematological Malignancies With Emphasis on Cardiac Repolarization|
- ECG interval change [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
- Safety/Efficacy [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2008|
|Estimated Study Completion Date:||July 2009|
|Estimated Primary Completion Date:||March 2009 (Final data collection date for primary outcome measure)|
Experimental: Single Arm
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.
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.
|United States, Arizona|
|Premiere Oncology of Arizona|
|Scottsdale, Arizona, United States, 85258|
|United States, California|
|Moores UCSD Cancer Center|
|La Jolla, California, United States, 92093|
|Santa Monica, California, United States, 90404|
|United States, Georgia|
|Georgia Cancer Specialists|
|Atlanta, Georgia, United States, 30341|
|United States, New Mexico|
|UNM Cancer Center|
|Albuquerque, New Mexico, United States, 87131|
|United States, Washington|
|Swedish Cancer Institute|
|Seattle, Washington, United States, 98104|
|Northwest Medical Specialities|
|Tacoma, Washington, United States, 98405|
|Study Director:||Robert Earhart, MD, PhD||Poniard Pharmaceuticals|