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

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NCT00886743

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Study Location
Pfizer Investigational Site
Santa Monica, California, 90403, United States
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Contact
1-800-718-1021
[email protected]
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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Severe Thrombocytopenia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Severe ThrombocytopeniaStudy Evaluating The Effects Of Oprelvekin On Cardiac Repolarization In Subjects With Chemotherapy Induced Thrombocytopenia NCT00886743
  1. Santa Monica, California
  2. Santa Monica, California
  3. District of Columbia, District of Columbia
  4. Washington, District of Columbia
  5. Washington, District of Columbia
  6. Mount Sterling, Kentucky
  7. Mount Sterling, Kentucky
  8. Canton, Ohio
  9. Canton, Ohio
  10. Dover, Ohio
  11. Dover, Ohio
  12. Middletown, Ohio
  13. Middletown, Ohio
  14. Laredo, Texas
  15. Laredo, Texas
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating The Effects Of Oprelvekin On Cardiac Repolarization In Subjects With Chemotherapy Induced Thrombocytopenia
Official Title  ICMJE Study Of The Effects Of Oprelvekin On Cardiac Repolarization In Subjects At Risk Of Severe Thrombocytopenia After Myelosuppressive Chemotherapy
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Severe Thrombocytopenia
Intervention  ICMJE Drug: oprelvekin
injection, 50 mg/kg, once daily
Study Arms  ICMJE Oprelvekin as subcutaneous injection (50 mg/kg once daily)
Open label treatment with oprelvekin
Intervention: Drug: oprelvekin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 5, 2016)		19
Original Estimated Enrollment  ICMJE
 (submitted: April 22, 2009)		40
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries Puerto Rico
 
Administrative Information
NCT Number  ICMJE NCT00886743
Other Study ID Numbers  ICMJE 3067K1-2213
B2491001 ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP