This is an open-label study in which oprelvekin will be administered for the prevention of severe low blood platelet cell counts (cells in your blood that keep bleeding and clotting stable) in adults with cancer who are taking chemotherapy (anti-cancer drug) that has a side effect of blocking your bone marrow from making platelet cells. The purpose of this study is to learn more about the effects of the recommended dose of oprelvekin on the heart's electrical cycle.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
19
injection, 50 mg/kg, once daily
Pfizer Investigational Site
Santa Monica, California, United States
Sarcoma Oncology Center
Santa Monica, California, United States
Howard University
Time-matched Change From Baseline in Corrected QT Interval Using a Population-specific Correction Formula (QTcN)
Because the sponsor terminated the study prematurely, this population-specific correction of QT was not done. QT data collected during the study corrected using the Bazett's and Fridericia formulae are presented as secondary outcome measures.
Time frame: Postdose Day 1 to end of treatment
Number of Participants With Time-matched Change From Baseline in Corrected QT (QTc) Interval ≥30 or 60 Msec Using Fridericia's (QTcF) and Bazett's (QTcB) Correction Formulas
Based on average across triplicates for a given hourly measurement.
Time frame: Postdose Day 1 to end of treatment
Number of Participants With Corrected QT (QTc) Interval ≥450, ≥480, and ≥500 Msec Using Bazett's (QTcB) and Fridericia's (QTcF) Correction Formulas
Definition of QTc is based on observed individual values rather than the average across triplicate starting from Day 1 postdose through the end of treatment.
Time frame: Postdose Day 1 to end of treatment
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Washington D.C., District of Columbia, United States
Pfizer Investigational Site
Washington D.C., District of Columbia, United States
Montgomery Cancer Center
Mount Sterling, Kentucky, United States
Pfizer Investigational Site
Mount Sterling, Kentucky, United States
Gabrail Cancer Center Research
Canton, Ohio, United States
Pfizer Investigational Site
Canton, Ohio, United States
Gabrail Cancer Center Research
Dover, Ohio, United States
Pfizer Investigational Site
Dover, Ohio, United States
...and 4 more locations