Study Evaluating The Effects Of Oprelvekin On Cardiac Repolarization In Subjects With Chemotherapy Induced Thrombocytopenia
Information source: Pfizer
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Severe Thrombocytopenia
Intervention: oprelvekin (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Pfizer Official(s) and/or principal investigator(s): Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Overall contact: Pfizer CT.gov Call Center, Phone: 1-800-718-1021
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.
Clinical Details
Official title: Study Of The Effects Of Oprelvekin On Cardiac Repolarization In Subjects At Risk Of Severe Thrombocytopenia After Myelosuppressive Chemotherapy
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: 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.
Secondary outcome: Time-matched change from baseline in the following QT variables: Fridericia correction (QTcF), Bazett corrections (QTcB)Incidence of QTcN, QTcB and QTcF:>=450 msecs, >=480, >=500 msecs, time-matched change from baseline >=30 msecs, time-matched change from baseline >=60 msecs. Based on average across triplicates for a given hourly measurement. Pharmacokinetic (PK) parameter Cmax Pharmacokinetic (PK) parameter tmax Time-matched changes in vital signs and laboratory data. Based on the value or the average across measures for a given hourly time point if more than 1 measure taken.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Pfizer CT.gov Call Center, Phone: 1-800-718-1021
Sarcoma Oncology Center, Santa Monica, California 90403, United States; Terminated
Howard University, Washington, District of Columbia 20060, United States; Terminated
Montgomery Cancer Center, Mount Sterling, Kentucky 40353, United States; Terminated
Gabrail Cancer Center, Canton, Ohio 44718, United States; Terminated
Gabrail Cancer Center Research, Dover, Ohio 44622, United States; Terminated
Signal Point Hematology / Oncology Inc, Middletown, Ohio 45042, United States; Recruiting
Flavio Castaneda M.D., Laredo, Texas 78041, United States; Terminated
South Texas Research Alliance LLC., Laredo, Texas 78041, United States; Terminated
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: September 2009
Last updated: August 18, 2015
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