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

Pfizer

Status and phase

Terminated

Phase 2

Conditions

Severe Thrombocytopenia

Treatments

Drug: oprelvekin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00886743

B2491001 (Other Identifier)

3067K1-2213

Details and patient eligibility

About

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.

Enrollment

19 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.