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

Status:	Terminated
Conditions:	Hematology
Therapuetic Areas:	Hematology
Healthy:	No
Age Range:	18 - 65
Updated:	4/21/2016
Start Date:	September 2009
End Date:	September 2015

Study Of The Effects Of Oprelvekin On Cardiac Repolarization In Subjects At Risk Of Severe Thrombocytopenia After Myelosuppressive Chemotherapy

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.

Inclusion Criteria:

- 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 Criteria:

- 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.

We found this trial at

sites

Flavio Castaneda M.D.

Laredo, Texas 78041

from

Laredo, TX