Study Of The Effects Of Oprelvekin On Cardiac Repolarization In Subjects At Risk Of Severe Thrombocytopenia After Myelosuppressive Chemotherapy
Phase 2
18 Years
65 Years
18 Years
65 Years
Open (Enrolling)
Both
Severe Thrombocytopenia
Both
Severe Thrombocytopenia
Trial Information
Study Of The Effects Of Oprelvekin On Cardiac Repolarization In Subjects At Risk Of Severe Thrombocytopenia After Myelosuppressive Chemotherapy
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Time-matched change from baseline in QT interval corrected for heart rate using a population-specific correction formula (QTcN). Based on average across triplicates for a given hourly time point after subcutaneous (SC) administration of oprelvekin.
Outcome Time Frame:
35 months
Safety Issue:
Yes
Principal Investigator
Pfizer CT.gov Call Center
Investigator Role:
Study Director
Investigator Affiliation:
Pfizer
Authority:
United States: Food and Drug Administration
Study ID:
3067K1-2213
NCT ID:
NCT00886743
Start Date:
September 2009
Completion Date:
August 2014
Related Keywords:
- Severe Thrombocytopenia
- Thrombocytopenia
Name | Location |
|---|---|
| Pfizer Investigational Site | Blendora, California 91740 |
| Pfizer Investigational Site | Crestview Hills, Kentucky 41017 |
| Pfizer Investigational Site | Detroit, Michigan 48201 |
| Pfizer Investigational Site | Cincinnait, Ohio 45236 |
| Pfizer Investigational Site | Houston, Texas 77030 |
| Pfizer Investigational Site | Washington, District of Columbia 20007-2197 |
