Skip to main content
OpenTrials
Completed

NCT Number: NCT02031991

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Neoplasms

Age range

21 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

South Miami, Florida, 33143, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PF-06439535

Biological

Solution for intravenous infusion, single dose of 5mg/kg, administered as 90-minute infusion.

Other names: PF-06439535, a potential biosimilar to bevacizumab

Avastin

Biological

Solution for intravenous infusion, single dose of 5mg/kg, administered as 90-minute infusion.

Other names: Bevacizumab (European Union)

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jan 9, 2014
Registry last updated
Aug 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.