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

This study has been terminated.
(Business reason, Pfizer's requested withdrawal of the Biologics License Application (BLA) . This study is not being discontinued for efficacy or safety reason)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00886743
First received: April 22, 2009
Last updated: March 8, 2017
Last verified: March 2017
  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: Intervention Model: Single Group Assignment
Masking: No masking
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 Corrected QT Interval Using a Population-specific Correction Formula (QTcN) [ Time Frame: Postdose Day 1 to end of treatment ]
    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.


Secondary Outcome Measures:
  • 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 [ Time Frame: Postdose Day 1 to end of treatment ]
    Based on average across triplicates for a given hourly measurement.

  • Number of Participants With Corrected QT (QTc) Interval ≥450, ≥480, and ≥500 Msec Using Bazett's (QTcB) and Fridericia's (QTcF) Correction Formulas [ Time Frame: Postdose Day 1 to end of treatment ]
    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.


Other Outcome Measures:
  • Maximum Observed Plasma Concentration (Cmax) of Oprelvekin [ Time Frame: Postdose Day 1 to end of treatment ]
    Cmax was obtained directly from the serum oprelvekin concentration data using noncompartmental methods.

  • Time to Reach Maximum Observed Plasma Concentration (Tmax) of Oprelvekin [ Time Frame: Postdose Day 1 to end of treatment ]
    Tmax was obtained directly from the serum oprelvekin concentration data using noncompartmental methods.


Enrollment: 19
Study Start Date: September 2009
Study Completion Date: December 2015
Primary Completion Date: December 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   (Adult)
Sexes Eligible for Study:   All
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

Locations
United States, California
Pfizer Investigational Site
Santa Monica, California, United States, 90403
Sarcoma Oncology Center
Santa Monica, California, United States, 90403
United States, District of Columbia
Pfizer Investigational Site
District of Columbia, District of Columbia, United States, 20060
Howard University
Washington, District of Columbia, United States, 20060
Pfizer Investigational Site
Washington, District of Columbia, United States, 20060
United States, Kentucky
Montgomery Cancer Center
Mount Sterling, Kentucky, United States, 40353
Pfizer Investigational Site
Mount Sterling, Kentucky, United States, 40353
United States, Ohio
Gabrail Cancer Center Research
Canton, Ohio, United States, 44718
Pfizer Investigational Site
Canton, Ohio, United States, 44718
Gabrail Cancer Center Research
Dover, Ohio, United States, 44622
Pfizer Investigational Site
Dover, Ohio, United States, 44622
Pfizer Investigational Site
Middletown, Ohio, United States, 45042
Signal Point Clinical Research Center, LLC
Middletown, Ohio, United States, 45042
United States, Texas
Pfizer Investigational Site
Laredo, Texas, United States, 78041
South Texas Research Alliance LLC.
Laredo, Texas, United States, 78041
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00886743     History of Changes
Other Study ID Numbers: 3067K1-2213
B2491001 ( Other Identifier: Alias Study Number )
Study First Received: April 22, 2009
Results First Received: November 14, 2016
Last Updated: March 8, 2017

Additional relevant MeSH terms:
Thrombocytopenia
Blood Platelet Disorders
Hematologic Diseases
Oprelvekin
Antineoplastic Agents

ClinicalTrials.gov processed this record on April 28, 2017