Clinical trial NCT00886743: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Severe Thrombocytopenia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-04-23
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Time-matched Change From Baseline in Corrected QT Interval Using a Population-specific Correction Formula (QTcN)
timeFrame: Postdose Day 1 to end of treatment
Secondary outcomes:
measure: 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
timeFrame: Postdose Day 1 to end of treatment
measure: Number of Participants With Corrected QT (QTc) Interval ≥450, ≥480, and ≥500 Msec Using Bazett's (QTcB) and Fridericia's (QTcF) Correction Formulas
timeFrame: Postdose Day 1 to end of treatment
Other outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) of Oprelvekin
timeFrame: Postdose Day 1 to end of treatment
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Oprelvekin
timeFrame: Postdose Day 1 to end of treatment
Locations:
city: Santa Monica
country: United States
facility: Pfizer Investigational Site
state: California
city: Santa Monica
country: United States
facility: Sarcoma Oncology Center
state: California
city: District of Columbia
country: United States
facility: Pfizer Investigational Site
state: District of Columbia
city: Washington
country: United States
facility: Howard University
state: District of Columbia
city: Washington
country: United States
facility: Pfizer Investigational Site
state: District of Columbia
city: Mount Sterling
country: United States
facility: Montgomery Cancer Center
state: Kentucky
city: Mount Sterling
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Canton
country: United States
facility: Gabrail Cancer Center Research
state: Ohio
city: Canton
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Dover
country: United States
facility: Gabrail Cancer Center Research
state: Ohio
city: Dover
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Middletown
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Middletown
country: United States
facility: Signal Point Clinical Research Center, LLC
state: Ohio
city: Laredo
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Laredo
country: United States
facility: South Texas Research Alliance LLC.
state: Texas
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: