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A Pharmacokinetic Study Comparing PF-06439535 And Bevacizumab In Healthy Male Volunteers (REFLECTIONS B739-01)

Last updated on November 16, 2019

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Study Location
Pfizer Investigational Site
South Miami, Florida, 33143 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
21-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy male subjects 21-55 years old

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

- Evidence or history of a clinically significant disease or clinical finding at
Screening

- Previous treatment with an anti-VEGF antibody, or any other antibody or protein
targeting the VEGF receptor.

NCT02031991
Pfizer
Completed
A Pharmacokinetic Study Comparing PF-06439535 And Bevacizumab In Healthy Male Volunteers (REFLECTIONS B739-01)

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Descriptive Information
Brief Title  ICMJE A Pharmacokinetic Study Comparing PF-06439535 And Bevacizumab In Healthy Male Volunteers (REFLECTIONS B739-01)
Official Title  ICMJE Phase 1, Double Blind, Randomized, Parallel-Group, Single-Dose, 3-Arm, Comparative Pharmacokinetic Study Of PF-06439535 And Bevacizumab Sourced From US And EU Administered To Healthy Male Volunteers
Brief Summary

This study is to prove that the handling (also referred to as pharmacokinetics) of the following drugs PF-06439535, Avastin® (bevacizumab) that is licensed for use in the United States (bevacizumab-US) and Avastin® (bevacizumab) obtained from Europe (bevacizumab-EU) is similar in healthy male volunteers after receiving a single intravenous dose of either drugs.

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.

Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Biological: PF-06439535
    Solution for intravenous infusion, single dose of 5mg/kg, administered as 90-minute infusion.
    Other Name: PF-06439535, a potential biosimilar to bevacizumab
  • Biological: Avastin
    Solution for intravenous infusion, single dose of 5mg/kg, administered as 90-minute infusion.
    Other Name: Bevacizumab (European Union)
  • Biological: Avastin
    Solution for intravenous infusion, single dose of 5mg/kg, administered as 90-minute infusion.
    Other Name: Bevacizumab (United States)
Study Arms  ICMJE
  • Experimental: A = PF-06439535
    Intervention Description: Sterile vial 400mg, single-dose 5mg/kg administered as 90-minute infusion on day 1.
    Intervention: Biological: PF-06439535
  • Active Comparator: B = Bevacizumab-EU
    Intervention Description: Sterile vial 400mg, single-dose 5mg/kg administered as 90-minute infusion on day 1.
    Intervention: Biological: Avastin
  • Active Comparator: C = Bevacizumab-US
    Intervention Description: Sterile vial 400mg, single-dose 5mg/kg administered as 90-minute infusion on day 1.
    Intervention: Biological: Avastin
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 Completed
Actual Enrollment  ICMJE
 (submitted: August 14, 2014)
102
Original Estimated Enrollment  ICMJE
 (submitted: January 7, 2014)
96
Actual Study Completion Date  ICMJE August 2014
Actual Primary Completion DateAugust 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male subjects 21-55 years old
  • 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:

  • Evidence or history of a clinically significant disease or clinical finding at Screening
  • Previous treatment with an anti-VEGF antibody, or any other antibody or protein targeting the VEGF receptor.
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Ages  ICMJE 21 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02031991
Other Study ID Numbers  ICMJE B7391001
REFLECTIONS B739-01
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateAugust 2014

ICMJE     Data element required by the

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

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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1-800-718-1021

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