Study Evaluating The Effects Of Oprelvekin On Cardiac Repolarization In Subjects With Chemotherapy Induced Thrombocytopenia

Stopped early · Phase 2

Conditions studied: Severe Thrombocytopenia

In brief

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.

Key facts

Study ID

NCT00886743

Run by

Pfizer

People needed

19

Starts

2009-09-01

Expected to finish

2015-12-01

Last updated by the study team

2017-04-19

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Pfizer Investigational Site — Santa Monica, California, United States
• Sarcoma Oncology Center — Santa Monica, California, United States
• Howard University — 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
• Pfizer Investigational Site — Middletown, Ohio, United States
• Signal Point Clinical Research Center, LLC — Middletown, Ohio, United States
• Pfizer Investigational Site — Laredo, Texas, United States
• South Texas Research Alliance LLC. — Laredo, Texas, United States

Full record on ClinicalTrials.gov

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