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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Biological: Avastin; Biological: PF-06439535

Study type: Interventional

Funder types: Industry

Identifiers

NCT02031991

REFLECTIONS B739-01

B7391001

Details and patient eligibility

About

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.

Enrollment: 102 patients

Sex: Male

Ages: 21 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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102 participants in 3 patient groups

A = PF-06439535

Experimental group

Description:

Intervention Description: Sterile vial 400mg, single-dose 5mg/kg administered as 90-minute infusion on day 1.

Treatment:

Biological: PF-06439535

B = Bevacizumab-EU

Active Comparator group

Description:

Intervention Description: Sterile vial 400mg, single-dose 5mg/kg administered as 90-minute infusion on day 1.

Treatment:

Biological: Avastin

Biological: Avastin

C = Bevacizumab-US

Active Comparator group

Description:

Intervention Description: Sterile vial 400mg, single-dose 5mg/kg administered as 90-minute infusion on day 1.

Treatment:

Biological: Avastin

Biological: Avastin