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

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00886743

Enrollment

Registered

2009-04-23

Start date

2009-09-30

Completion date

2015-12-31

Last updated

2017-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe Thrombocytopenia

Brief summary

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.

Interventions

DRUGoprelvekin

injection, 50 mg/kg, once daily

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Time-matched Change From Baseline in Corrected QT Interval Using a Population-specific Correction Formula (QTcN)	Postdose Day 1 to end of treatment	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.

Secondary

Measure	Time frame	Description
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	Postdose Day 1 to end of treatment	Based on average across triplicates for a given hourly measurement.
Number of Participants With Corrected QT (QTc) Interval ≥450, ≥480, and ≥500 Msec Using Bazett's (QTcB) and Fridericia's (QTcF) Correction Formulas	Postdose Day 1 to end of treatment	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.

Other

Measure	Time frame	Description
Maximum Observed Plasma Concentration (Cmax) of Oprelvekin	Postdose Day 1 to end of treatment	Cmax was obtained directly from the serum oprelvekin concentration data using noncompartmental methods.
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Oprelvekin	Postdose Day 1 to end of treatment	Tmax was obtained directly from the serum oprelvekin concentration data using noncompartmental methods.

Countries

United States

Participant flow

Pre-assignment details

A total of 45 participants were screened; of these, 19 received treatment.

Participants by arm

Arm	Count
Oprelvekin, 50 μg/kg Participants received 50 μg/kg of oprelvekin once daily by subcutaneous injection.	19
Total	19

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Adverse Event	3
Overall Study	Other	1

Baseline characteristics

Characteristic	Oprelvekin, 50 μg/kg
Age, Continuous	49.5 Years STANDARD_DEVIATION 9.6
Body Mass Index	26.7 Kilograms/meters^2 STANDARD_DEVIATION 7.9
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants
Race/Ethnicity, Customized Black or African American	2 Participants
Race/Ethnicity, Customized White	17 Participants
Sex: Female, Male Female	11 Participants
Sex: Female, Male Male	8 Participants
Weight	76.9 Kilograms STANDARD_DEVIATION 25.7

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	14 / 19
serious Total, serious adverse events	1 / 19

Outcome results

Primary

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.