Status:
TERMINATED
Study Evaluating The Effects Of Oprelvekin On Cardiac Repolarization In Subjects With Chemotherapy Induced Thrombocytopenia
Lead Sponsor:
Pfizer
Conditions:
Severe Thrombocytopenia
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- Men and women must be 18 to 65 years of age, with nonmyeloid malignancies for whom oprelvekin is indicated.
- At least one documented occasion of adequate hematologic recovery from previous or current chemotherapy.
- Adequate renal and hepatic excretory function.
Exclusion
- A marked baseline prolongation of QT/QTc interval (eg, repeated \[two out of three readings\] demonstration of a QTcF interval \>450 msec.
- Additional risk factors for torsades de pointes including heart failure (subjects that have functional class III or IV congestive heart failure), hypokalemia, hypomagnesemia, or hypocalcemia.
- A pace maker or defibrillator.
- A history of LQTS, syncope, seizure, or the unexplained cardiac-related death of a family member at less than 30 years of age.
- Requirement of concomitant prescription or non-prescription medications or dietary supplements that have a risk of causing torsades de pointes or prolonged QT/QTc interval.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00886743
Start Date
September 1 2009
End Date
December 1 2015
Last Update
April 19 2017
Active Locations (14)
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1
Pfizer Investigational Site
Santa Monica, California, United States, 90403
2
Sarcoma Oncology Center
Santa Monica, California, United States, 90403
3
Howard University
Washington D.C., District of Columbia, United States, 20060
4
Pfizer Investigational Site
Washington D.C., District of Columbia, United States, 20060