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

Primary Purpose

Severe Thrombocytopenia

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
oprelvekin
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Thrombocytopenia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pfizer Investigational Site
  • Sarcoma Oncology Center
  • Pfizer Investigational Site
  • Howard University
  • Pfizer Investigational Site
  • Montgomery Cancer Center
  • Pfizer Investigational Site
  • Gabrail Cancer Center Research
  • Pfizer Investigational Site
  • Gabrail Cancer Center Research
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Signal Point Clinical Research Center, LLC
  • Pfizer Investigational Site
  • South Texas Research Alliance LLC.

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Oprelvekin as subcutaneous injection (50 mg/kg once daily)

Arm Description

Open label treatment with oprelvekin

Outcomes

Primary Outcome Measures

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.

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
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
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.

Full Information

First Posted
April 22, 2009
Last Updated
March 8, 2017
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00886743
Brief Title
Study Evaluating The Effects Of Oprelvekin On Cardiac Repolarization In Subjects With Chemotherapy Induced Thrombocytopenia
Official Title
Study Of The Effects Of Oprelvekin On Cardiac Repolarization In Subjects At Risk Of Severe Thrombocytopenia After Myelosuppressive Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Terminated
Why Stopped
Business reason, Pfizer's requested withdrawal of the Biologics License Application (BLA) . This study is not being discontinued for efficacy or safety reason
Study Start Date
September 2009 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Thrombocytopenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oprelvekin as subcutaneous injection (50 mg/kg once daily)
Arm Type
Other
Arm Description
Open label treatment with oprelvekin
Intervention Type
Drug
Intervention Name(s)
oprelvekin
Intervention Description
injection, 50 mg/kg, once daily
Primary Outcome Measure Information:
Title
Time-matched Change From Baseline in Corrected QT Interval Using a Population-specific Correction Formula (QTcN)
Description
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.
Time Frame
Postdose Day 1 to end of treatment
Secondary Outcome Measure Information:
Title
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
Description
Based on average across triplicates for a given hourly measurement.
Time Frame
Postdose Day 1 to end of treatment
Title
Number of Participants With Corrected QT (QTc) Interval ≥450, ≥480, and ≥500 Msec Using Bazett's (QTcB) and Fridericia's (QTcF) Correction Formulas
Description
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.
Time Frame
Postdose Day 1 to end of treatment
Other Pre-specified Outcome Measures:
Title
Maximum Observed Plasma Concentration (Cmax) of Oprelvekin
Description
Cmax was obtained directly from the serum oprelvekin concentration data using noncompartmental methods.
Time Frame
Postdose Day 1 to end of treatment
Title
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Oprelvekin
Description
Tmax was obtained directly from the serum oprelvekin concentration data using noncompartmental methods.
Time Frame
Postdose Day 1 to end of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Santa Monica
State/Province
California
ZIP/Postal Code
90403
Country
United States
Facility Name
Sarcoma Oncology Center
City
Santa Monica
State/Province
California
ZIP/Postal Code
90403
Country
United States
Facility Name
Pfizer Investigational Site
City
District of Columbia
State/Province
District of Columbia
ZIP/Postal Code
20060
Country
United States
Facility Name
Howard University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20060
Country
United States
Facility Name
Pfizer Investigational Site
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20060
Country
United States
Facility Name
Montgomery Cancer Center
City
Mount Sterling
State/Province
Kentucky
ZIP/Postal Code
40353
Country
United States
Facility Name
Pfizer Investigational Site
City
Mount Sterling
State/Province
Kentucky
ZIP/Postal Code
40353
Country
United States
Facility Name
Gabrail Cancer Center Research
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Pfizer Investigational Site
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Gabrail Cancer Center Research
City
Dover
State/Province
Ohio
ZIP/Postal Code
44622
Country
United States
Facility Name
Pfizer Investigational Site
City
Dover
State/Province
Ohio
ZIP/Postal Code
44622
Country
United States
Facility Name
Pfizer Investigational Site
City
Middletown
State/Province
Ohio
ZIP/Postal Code
45042
Country
United States
Facility Name
Signal Point Clinical Research Center, LLC
City
Middletown
State/Province
Ohio
ZIP/Postal Code
45042
Country
United States
Facility Name
Pfizer Investigational Site
City
Laredo
State/Province
Texas
ZIP/Postal Code
78041
Country
United States
Facility Name
South Texas Research Alliance LLC.
City
Laredo
State/Province
Texas
ZIP/Postal Code
78041
Country
United States

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=3067K1-2213&StudyName=Study%20Evaluating%20The%20Effects%20Of%20Oprelvekin%20On%20Cardiac%20Repolarization%20In%20Subjects%20With%20Chemotherapy%20Induced%20Thrombocytopenia
Description
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Study Evaluating The Effects Of Oprelvekin On Cardiac Repolarization In Subjects With Chemotherapy Induced Thrombocytopenia

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