Trial Outcomes & Findings for Study Evaluating The Effects Of Oprelvekin On Cardiac Repolarization In Subjects With Chemotherapy Induced Thrombocytopenia (NCT NCT00886743)
NCT ID: NCT00886743
Last Updated: 2017-04-19
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
19 participants
Primary outcome timeframe
Postdose Day 1 to end of treatment
Results posted on
2017-04-19
Participant Flow
A total of 45 participants were screened; of these, 19 received treatment.
Participant milestones
| Measure |
Oprelvekin, 50 μg/kg
Participants received 50 μg/kg of oprelvekin once daily by subcutaneous injection.
|
|---|---|
|
Overall Study
STARTED
|
19
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Oprelvekin, 50 μg/kg
Participants received 50 μg/kg of oprelvekin once daily by subcutaneous injection.
|
|---|---|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Other
|
1
|
Baseline Characteristics
Study Evaluating The Effects Of Oprelvekin On Cardiac Repolarization In Subjects With Chemotherapy Induced Thrombocytopenia
Baseline characteristics by cohort
| Measure |
Oprelvekin, 50 μg/kg
n=19 Participants
Participants received 50 μg/kg of oprelvekin once daily by subcutaneous injection.
|
|---|---|
|
Age, Continuous
|
49.5 Years
STANDARD_DEVIATION 9.60 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
17 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=5 Participants
|
|
Weight
|
76.9 Kilograms
STANDARD_DEVIATION 25.7 • n=5 Participants
|
|
Body Mass Index
|
26.7 Kilograms/meters^2
STANDARD_DEVIATION 7.9 • n=5 Participants
|
PRIMARY outcome
Timeframe: Postdose Day 1 to end of treatmentBecause 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Postdose Day 1 to end of treatmentPopulation: Participants who completed baseline and postdose triplicate electrocardiograms through at least 3 continuous days of dosing. Those who received any systemic concomitant medications that had the potential for drug interaction and sporadic effect on QT/QTc data, and thus impacted results, were excluded from the analyses.
Based on average across triplicates for a given hourly measurement.
Outcome measures
| Measure |
Oprelvekin, 50 μg/kg
n=19 Participants
Participants received 50 μg/kg of oprelvekin once daily by subcutaneous injection.
|
|---|---|
|
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
QTcF change ≥30 msec
|
5 Participants
|
|
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
QTcF change ≥60 msec
|
0 Participants
|
|
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
QTcB change ≥30 msec
|
9 Participants
|
|
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
QTcB change ≥60 msec
|
2 Participants
|
SECONDARY outcome
Timeframe: Postdose Day 1 to end of treatmentPopulation: Participants who completed baseline and postdose triplicate electrocardiograms through at least 3 continuous days of dosing. Those who received any systemic concomitant medications that had the potential for drug interaction and sporadic effect on QT/QTc data, and thus impacted results, were excluded from the analyses.
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.
Outcome measures
| Measure |
Oprelvekin, 50 μg/kg
n=19 Participants
Participants received 50 μg/kg of oprelvekin once daily by subcutaneous injection.
|
|---|---|
|
Number of Participants With Corrected QT (QTc) Interval ≥450, ≥480, and ≥500 Msec Using Bazett's (QTcB) and Fridericia's (QTcF) Correction Formulas
QTcF ≥450 msec
|
2 Participants
|
|
Number of Participants With Corrected QT (QTc) Interval ≥450, ≥480, and ≥500 Msec Using Bazett's (QTcB) and Fridericia's (QTcF) Correction Formulas
QTcF ≥480 msec
|
0 Participants
|
|
Number of Participants With Corrected QT (QTc) Interval ≥450, ≥480, and ≥500 Msec Using Bazett's (QTcB) and Fridericia's (QTcF) Correction Formulas
QTcF ≥500 mec
|
0 Participants
|
|
Number of Participants With Corrected QT (QTc) Interval ≥450, ≥480, and ≥500 Msec Using Bazett's (QTcB) and Fridericia's (QTcF) Correction Formulas
QTcB ≥450 msec
|
13 Participants
|
|
Number of Participants With Corrected QT (QTc) Interval ≥450, ≥480, and ≥500 Msec Using Bazett's (QTcB) and Fridericia's (QTcF) Correction Formulas
QTcB ≥480 msec
|
3 Participants
|
|
Number of Participants With Corrected QT (QTc) Interval ≥450, ≥480, and ≥500 Msec Using Bazett's (QTcB) and Fridericia's (QTcF) Correction Formulas
QTcB ≥500 mec
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Postdose Day 1 to end of treatmentPopulation: All participants who received at least 1 dose of study drug and had at least 1 concentration assessment.
Cmax was obtained directly from the serum oprelvekin concentration data using noncompartmental methods.
Outcome measures
| Measure |
Oprelvekin, 50 μg/kg
n=11 Participants
Participants received 50 μg/kg of oprelvekin once daily by subcutaneous injection.
|
|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of Oprelvekin
Participant 1
|
15900 picograms/mililiter
|
|
Maximum Observed Plasma Concentration (Cmax) of Oprelvekin
Participant 2
|
20100 picograms/mililiter
|
|
Maximum Observed Plasma Concentration (Cmax) of Oprelvekin
Participant 3
|
20200 picograms/mililiter
|
|
Maximum Observed Plasma Concentration (Cmax) of Oprelvekin
Participant 4
|
17000 picograms/mililiter
|
|
Maximum Observed Plasma Concentration (Cmax) of Oprelvekin
Participant 5
|
12200 picograms/mililiter
|
|
Maximum Observed Plasma Concentration (Cmax) of Oprelvekin
Participant 6
|
19100 picograms/mililiter
|
|
Maximum Observed Plasma Concentration (Cmax) of Oprelvekin
Participant 7
|
17300 picograms/mililiter
|
|
Maximum Observed Plasma Concentration (Cmax) of Oprelvekin
Participant 8
|
17500 picograms/mililiter
|
|
Maximum Observed Plasma Concentration (Cmax) of Oprelvekin
Participant 9
|
34500 picograms/mililiter
|
|
Maximum Observed Plasma Concentration (Cmax) of Oprelvekin
Participant 10
|
25000 picograms/mililiter
|
|
Maximum Observed Plasma Concentration (Cmax) of Oprelvekin
Participant 11
|
24000 picograms/mililiter
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Postdose Day 1 to end of treatmentPopulation: All participants who received at least 1 dose of study drug and had at least 1 concentration assessment.
Tmax was obtained directly from the serum oprelvekin concentration data using noncompartmental methods.
Outcome measures
| Measure |
Oprelvekin, 50 μg/kg
n=11 Participants
Participants received 50 μg/kg of oprelvekin once daily by subcutaneous injection.
|
|---|---|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Oprelvekin
Participant 2
|
4 hours
|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Oprelvekin
Participant 3
|
6 hours
|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Oprelvekin
Participant 4
|
3 hours
|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Oprelvekin
Participant 5
|
5 hours
|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Oprelvekin
Participant 6
|
3 hours
|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Oprelvekin
Participant 7
|
3 hours
|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Oprelvekin
Participant 8
|
6 hours
|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Oprelvekin
Participant 9
|
3 hours
|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Oprelvekin
Participant 10
|
3 hours
|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Oprelvekin
Participant 11
|
2 hours
|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Oprelvekin
Participant 1
|
1 hours
|
Adverse Events
Oprelvekin, 50 μg/kg
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Oprelvekin, 50 μg/kg
n=19 participants at risk
Participants received 50 μg/kg of oprelvekin once daily by subcutaneous injection.
|
|---|---|
|
Infections and infestations
Sepsis
|
5.3%
1/19 • Number of events 1
|
Other adverse events
| Measure |
Oprelvekin, 50 μg/kg
n=19 participants at risk
Participants received 50 μg/kg of oprelvekin once daily by subcutaneous injection.
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
5.3%
1/19 • Number of events 1
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.3%
1/19 • Number of events 1
|
|
Cardiac disorders
Atrioventricular block first degree
|
5.3%
1/19 • Number of events 1
|
|
Cardiac disorders
Sinus bradycardia
|
5.3%
1/19 • Number of events 1
|
|
Cardiac disorders
Sinus tachycardia
|
5.3%
1/19 • Number of events 1
|
|
Eye disorders
Ocular hyperaemia
|
5.3%
1/19 • Number of events 1
|
|
Eye disorders
Vision blurred
|
10.5%
2/19 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal tenderness
|
5.3%
1/19 • Number of events 1
|
|
Gastrointestinal disorders
Mouth ulceration
|
5.3%
1/19 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
5.3%
1/19 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
5.3%
1/19 • Number of events 1
|
|
General disorders
Fatigue
|
5.3%
1/19 • Number of events 1
|
|
General disorders
Oedema peripheral
|
5.3%
1/19 • Number of events 1
|
|
General disorders
Pyrexia
|
5.3%
1/19 • Number of events 1
|
|
Infections and infestations
Bronchitis
|
5.3%
1/19 • Number of events 1
|
|
Infections and infestations
Cellulitis
|
5.3%
1/19 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
5.3%
1/19 • Number of events 1
|
|
Injury, poisoning and procedural complications
Excoriation
|
5.3%
1/19 • Number of events 1
|
|
Investigations
Blood cholesterol increased
|
5.3%
1/19 • Number of events 1
|
|
Investigations
Blood triglycerides increased
|
5.3%
1/19 • Number of events 1
|
|
Investigations
Haematocrit decreased
|
5.3%
1/19 • Number of events 1
|
|
Investigations
Haemoglobin decreased
|
5.3%
1/19 • Number of events 1
|
|
Investigations
Heart rate decreased
|
5.3%
1/19 • Number of events 1
|
|
Investigations
Platelet count decreased
|
5.3%
1/19 • Number of events 1
|
|
Investigations
QRS axis abnormal
|
5.3%
1/19 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
10.5%
2/19 • Number of events 2
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.3%
1/19 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.3%
1/19 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
10.5%
2/19 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
5.3%
1/19 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
5.3%
1/19 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
15.8%
3/19 • Number of events 3
|
|
Nervous system disorders
Headache
|
5.3%
1/19 • Number of events 1
|
|
Nervous system disorders
Syncope
|
5.3%
1/19 • Number of events 1
|
|
Vascular disorders
Phlebitis
|
5.3%
1/19 • Number of events 1
|
|
Cardiac disorders
Short QT Interval with ST changes
|
5.3%
1/19 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER