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

Study Overview
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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.

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

Conditions
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Severe Thrombocytopenia

Intervention / Treatment
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* Drug: oprelvekin


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Oprelvekin as subcutaneous injection (50 mg/kg once daily)<br>Open label treatment with oprelvekin | Drug: oprelvekin<br>* injection, 50 mg/kg, once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time-matched Change From Baseline in Corrected QT Interval Using a Population-specific Correction Formula (QTcN) | Because the sponsor terminated the study prematurely, this population-specific correction of QT was not done. QT data collected during the study corrected using the Bazett's and Fridericia formulae are presented as secondary outcome measures. | Postdose Day 1 to end of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Time-matched Change From Baseline in Corrected QT (QTc) Interval ≥30 or 60 Msec Using Fridericia's (QTcF) and Bazett's (QTcB) Correction Formulas | Based on average across triplicates for a given hourly measurement. | Postdose Day 1 to end of treatment | 
| Number of Participants With Corrected QT (QTc) Interval ≥450, ≥480, and ≥500 Msec Using Bazett's (QTcB) and Fridericia's (QTcF) Correction Formulas | Definition of QTc is based on observed individual values rather than the average across triplicate starting from Day 1 postdose through the end of treatment. | Postdose Day 1 to end of treatment |