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


Phase 2
18 Years
65 Years
Open (Enrolling)
Both
Severe Thrombocytopenia

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time-matched change from baseline in QT interval corrected for heart rate using a population-specific correction formula (QTcN). Based on average across triplicates for a given hourly time point after subcutaneous (SC) administration of oprelvekin.

Outcome Time Frame:

35 months

Safety Issue:

Yes

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

3067K1-2213

NCT ID:

NCT00886743

Start Date:

September 2009

Completion Date:

August 2014

Related Keywords:

  • Severe Thrombocytopenia
  • Thrombocytopenia

Name

Location

Pfizer Investigational SiteBlendora, California  91740
Pfizer Investigational SiteCrestview Hills, Kentucky  41017
Pfizer Investigational SiteDetroit, Michigan  48201
Pfizer Investigational SiteCincinnait, Ohio  45236
Pfizer Investigational SiteHouston, Texas  77030
Pfizer Investigational SiteWashington, District of Columbia  20007-2197