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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2015-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Severe Thrombocytopenia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Oprelvekin as subcutaneous injection (50 mg/kg once daily)

Open label treatment with oprelvekin

Group Type OTHER

oprelvekin

Intervention Type DRUG

injection, 50 mg/kg, once daily

Interventions

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oprelvekin

injection, 50 mg/kg, once daily

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No