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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

Page last updated: August 20, 2015

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