A Pharmacokinetic Study Comparing PF-06439535 And Bevacizumab In Healthy Male Volunteers (REFLECTIONS B739-01)
NCT ID: NCT02031991
Last Updated: 2014-08-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
102 participants
INTERVENTIONAL
2014-01-31
2014-08-31
Brief Summary
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During the course of the study, the similarity in pharmacokinetics will be assessed by sampling the levels of drug in the blood, and by comparing these levels among the different administration arms of PF-06439535, bevacizumab-US and bevacizumab-EU. Safety, tolerability, and immunologic response to the administered drugs will also be evaluated throughout.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
TRIPLE
Study Groups
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A = PF-06439535
Intervention Description: Sterile vial 400mg, single-dose 5mg/kg administered as 90-minute infusion on day 1.
PF-06439535
Solution for intravenous infusion, single dose of 5mg/kg, administered as 90-minute infusion.
B = Bevacizumab-EU
Intervention Description: Sterile vial 400mg, single-dose 5mg/kg administered as 90-minute infusion on day 1.
Avastin
Solution for intravenous infusion, single dose of 5mg/kg, administered as 90-minute infusion.
C = Bevacizumab-US
Intervention Description: Sterile vial 400mg, single-dose 5mg/kg administered as 90-minute infusion on day 1.
Avastin
Solution for intravenous infusion, single dose of 5mg/kg, administered as 90-minute infusion.
Interventions
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PF-06439535
Solution for intravenous infusion, single dose of 5mg/kg, administered as 90-minute infusion.
Avastin
Solution for intravenous infusion, single dose of 5mg/kg, administered as 90-minute infusion.
Avastin
Solution for intravenous infusion, single dose of 5mg/kg, administered as 90-minute infusion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects who have previously been exposed to a biologic agent (other than a VEGF \[Vascular Endothelial Growth Factor Receptor\] inhibitor) may enroll provided that at least 3 months have passed since the last administration of that drug
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50kg (110lbs)
Exclusion Criteria
* Previous treatment with an anti-VEGF antibody, or any other antibody or protein targeting the VEGF receptor.
21 Years
55 Years
MALE
Yes
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
South Miami, Florida, United States
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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REFLECTIONS B739-01
Identifier Type: -
Identifier Source: secondary_id
B7391001
Identifier Type: -
Identifier Source: org_study_id
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