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

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ClinicalTrials.gov Identifier: NCT02031991
Recruitment Status : Completed
First Posted : January 9, 2014
Last Update Posted : August 15, 2014
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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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.


Condition or disease Intervention/treatment Phase
Healthy Biological: PF-06439535 Biological: Avastin Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Official Title: 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
Study Start Date : January 2014
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: A = PF-06439535
Intervention Description: Sterile vial 400mg, single-dose 5mg/kg administered as 90-minute infusion on day 1.
 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
Active Comparator: B = Bevacizumab-EU
Intervention Description: Sterile vial 400mg, single-dose 5mg/kg administered as 90-minute infusion on day 1.
 Biological: Avastin
Solution for intravenous infusion, single dose of 5mg/kg, administered as 90-minute infusion.
Other Name: Bevacizumab (European Union)
Active Comparator: C = Bevacizumab-US
Intervention Description: Sterile vial 400mg, single-dose 5mg/kg administered as 90-minute infusion on day 1.
 Biological: Avastin
Solution for intravenous infusion, single dose of 5mg/kg, administered as 90-minute infusion.
Other Name: Bevacizumab (United States)


Outcome Measures
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Primary Outcome Measures :
  1. Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Day 1 - Day 71 ]
  2. Area Under the Curve from Time Zero to end of dosing interval (AUCtau) [ Time Frame: Day 1 - Day 71 ]
  3. Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] [ Time Frame: Day 1 - Day 71 ]
    AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8).


Secondary Outcome Measures :
  1. Systemic Clearance (CL) [ Time Frame: Day 1 - Day 71 ]
  2. Terminal Disposition Half-Life (t1/2) [ Time Frame: Day 1 - Day 71 ]
  3. Volume of Distribution at Steady State (Vss) [ Time Frame: Day 1 - Day 71 ]
  4. Incidence of anti-bevacizumab antibodies (ADA), including neutralizing antibodies (Nab) [ Time Frame: Day 1 - Day 71 or LSLV, whichever occurs later ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02031991


Locations
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United States, Florida
Pfizer Investigational Site
South Miami, Florida, United States, 33143
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02031991    
Other Study ID Numbers: B7391001
REFLECTIONS B739-01
First Posted: January 9, 2014    Key Record Dates
Last Update Posted: August 15, 2014
Last Verified: August 2014
Keywords provided by Pfizer:
Bioequivalence
Biosimilarity
Similarity
PK
Phase 1
 Bevacizumab
Healthy Volunteers
Single-Dose
Oncology
Additional relevant MeSH terms:
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Bevacizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
 Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors