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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00886743
First received: April 22, 2009
Last updated: October 15, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Severe Thrombocytopenia
Drug: oprelvekin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study Of The Effects Of Oprelvekin On Cardiac Repolarization In Subjects At Risk Of Severe Thrombocytopenia After Myelosuppressive Chemotherapy

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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. [ Time Frame: 35 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Time-matched change from baseline in the following QT variables: Fridericia correction (QTcF), Bazett corrections (QTcB) [ Time Frame: 35 months ] [ Designated as safety issue: Yes ]
  • 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 [ Time Frame: 35 months ] [ Designated as safety issue: Yes ]
  • measurement. [ Time Frame: 35 months ] [ Designated as safety issue: Yes ]
  • Pharmacokinetic (PK) parameter Cmax [ Time Frame: 35 months ] [ Designated as safety issue: Yes ]
  • Pharmacokinetic (PK) parameter tmax [ Time Frame: 35 months ] [ Designated as safety issue: Yes ]
  • 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. [ Time Frame: 35 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 48
Study Start Date: September 2009
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Oprelvekin as subcutaneous injection (50 mg/kg once daily)
Open label treatment with oprelvekin
Drug: oprelvekin
injection, 50 mg/kg, once daily

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00886743

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

Locations
United States, California
Sarcoma Oncology Center Terminated
Santa Monica, California, United States, 90403
United States, District of Columbia
Howard University Terminated
Washington, District of Columbia, United States, 20060
Howard University_Project Manager Terminated
Washington DC., District of Columbia, United States, 20060
United States, Kentucky
Montgomery Cancer Center Recruiting
Mount Sterling, Kentucky, United States, 40353
United States, Ohio
Gabrail Cancer Center Terminated
Canton, Ohio, United States, 44718
Gabrail Cancer Center Research Terminated
Dover, Ohio, United States, 44622
Signal Point Hematology / Oncology Inc Recruiting
Middletown, Ohio, United States, 45042
United States, Texas
South Texas Research Alliance LLC. Active, not recruiting
Laredo, Texas, United States, 78041
Flavio Castaneda M.D. Active, not recruiting
Laredo, Texas, United States, 78041
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00886743     History of Changes
Other Study ID Numbers: 3067K1-2213, B2491001
Study First Received: April 22, 2009
Last Updated: October 15, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Thrombocytopenia
Blood Platelet Disorders
Hematologic Diseases
Oprelvekin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014