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

Study Of The Effects Of Oprelvekin On Cardiac Repolarization In Subjects At Risk Of Severe Thrombocytopenia After Myelosuppressive Chemotherapy

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.

Study Overview

• Status: Terminated
• Conditions: Severe Thrombocytopenia
• Intervention / Treatment: Drug: oprelvekin

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Santa Monica, California, United States, 90403
      • Sarcoma Oncology Center
    • Santa Monica, California, United States, 90403
      • Pfizer Investigational Site
  • District of Columbia
    • District of Columbia, District of Columbia, United States, 20060
      • Pfizer Investigational Site
    • Washington, District of Columbia, United States, 20060
      • Howard University
    • Washington, District of Columbia, United States, 20060
      • Pfizer Investigational Site
  • Kentucky
    • Mount Sterling, Kentucky, United States, 40353
      • Montgomery Cancer Center
    • Mount Sterling, Kentucky, United States, 40353
      • Pfizer Investigational Site
  • Ohio
    • 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
      • Gabrail Cancer Center Research
    • Middletown, Ohio, United States, 45042
      • Signal Point Clinical Research Center, LLC
    • Middletown, Ohio, United States, 45042
      • Pfizer Investigational Site
  • Texas
    • Laredo, Texas, United States, 78041
      • Pfizer Investigational Site
    • Laredo, Texas, United States, 78041
      • South Texas Research Alliance LLC.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Oprelvekin as subcutaneous injection (50 mg/kg once daily); Open label treatment with oprelvekin	Drug: oprelvekin; injection, 50 mg/kg, once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time-matched Change From Baseline in Corrected QT Interval Using a Population-specific Correction Formula (QTcN)	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.	Postdose Day 1 to end of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Based on average across triplicates for a given hourly measurement.	Postdose Day 1 to end of treatment
Number of Participants With Corrected QT (QTc) Interval ≥450, ≥480, and ≥500 Msec Using Bazett's (QTcB) and Fridericia's (QTcF) Correction Formulas	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.	Postdose Day 1 to end of treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Observed Plasma Concentration (Cmax) of Oprelvekin	Cmax was obtained directly from the serum oprelvekin concentration data using noncompartmental methods.	Postdose Day 1 to end of treatment
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Oprelvekin	Tmax was obtained directly from the serum oprelvekin concentration data using noncompartmental methods.	Postdose Day 1 to end of treatment

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: April 22, 2009
• First Submitted That Met QC Criteria: April 22, 2009
• First Posted (Estimate): April 23, 2009

Study Record Updates

• Last Update Posted (Actual): April 19, 2017
• Last Update Submitted That Met QC Criteria: March 8, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Blood Platelet Disorders; Thrombocytopenia; Antineoplastic Agents; Oprelvekin
• Other Study ID Numbers: 3067K1-2213; B2491001 (Other Identifier: Alias Study Number)