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

NCT02031991 | Completed Phase 1

• 2 other identifiers: B7391001REFLECTIONS B739-01
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Bioequivalence; Biosimilarity; Similarity; PK; Phase 1; Bevacizumab; Healthy Volunteers; Single-Dose; Oncology

Outcome Measures

Primary Outcomes (3)

• Maximum Observed Plasma Concentration (Cmax)

  Day 1 - Day 71

• Area Under the Curve from Time Zero to end of dosing interval (AUCtau)

  Day 1 - Day 71

• Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]

  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).

  Day 1 - Day 71

Secondary Outcomes (4)

• Systemic Clearance (CL)

  Day 1 - Day 71

• Terminal Disposition Half-Life (t1/2)

  Day 1 - Day 71

• Volume of Distribution at Steady State (Vss)

  Day 1 - Day 71

• Incidence of anti-bevacizumab antibodies (ADA), including neutralizing antibodies (Nab)

  Day 1 - Day 71 or LSLV, whichever occurs later

Study Arms (3)

A = PF-06439535

EXPERIMENTAL

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

Biological: PF-06439535

B = Bevacizumab-EU

ACTIVE COMPARATOR

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

Biological: Avastin

C = Bevacizumab-US

ACTIVE COMPARATOR

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

Biological: Avastin

Interventions

PF-06439535 BIOLOGICAL

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

Also known as: PF-06439535, a potential biosimilar to bevacizumab

A = PF-06439535

Avastin BIOLOGICAL

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

Also known as: Bevacizumab (European Union)

B = Bevacizumab-EU

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Investigational Site

South Miami, Florida, 33143, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Neoplasms

Interventions

Bevacizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2014
• First Posted: January 9, 2014
• Study Start: January 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: August 15, 2014

Record last verified: 2014-08

Locations

US (1)