You are here

Our science / Clinical Trials / Find a Trial / NCT00886743

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

Back to Search Print Save as PDF Bookmark Trial

NCT00886743

Last updated on May 10, 2018
Back to Search Print Save as PDF Bookmark Trial

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Santa Monica, California, 90403 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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.

NCT00886743
Pfizer
Terminated
Study Evaluating The Effects Of Oprelvekin On Cardiac Repolarization In Subjects With Chemotherapy Induced Thrombocytopenia

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.
Advanced Search

Similar Trials

Moderate-severe Pain
Open-Label Study in Children 7-17 Years for the Treatment of Moderate to Severe Pain
NCT02680847
All Genders
7+
Years
Multiple Sites
Severe Vasomotor Symptom Associated With Menopause
Post Marketing Surveillance To Observe Safety And Efficacy Of Duavive
NCT02792504
Females
20+
Years
Multiple Sites
Severe Hemophilia A
Efficacy & Safety of REFACTO AF in Prophylaxis Treatment
NCT02718677
Males
Moderate-severe Pain
Open-Label Study in Children 7-17 Years for the Treatment of Moderate to Severe Pain
NCT02101554
All Genders
7+
Years
Multiple Sites
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.
Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Severe Thrombocytopenia
Drug: oprelvekin
injection, 50 mg/kg, once daily
Oprelvekin as subcutaneous injection (50 mg/kg once daily)
Open label treatment with oprelvekin
Intervention: Drug: oprelvekin
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
19
December 2015
December 2015   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
Puerto Rico
 
NCT00886743
3067K1-2213
B2491001 ( Other Identifier: Alias Study Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now