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

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

Tracking Information

• First Submitted Date: January 7, 2014
• First Posted Date: January 9, 2014
• Last Update Posted Date: August 15, 2014
• Study Start Date: January 2014
• Actual Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 7, 2014)

• Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Day 1 - Day 71 ]
• Area Under the Curve from Time Zero to end of dosing interval (AUCtau) [ Time Frame: Day 1 - Day 71 ]
• 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).

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: January 7, 2014)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

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 Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Basic Science
• Condition: Healthy

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 14, 2014): 102
• Original Estimated Enrollment (submitted: January 7, 2014): 96
• Actual Study Completion Date: August 2014
• Actual Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 21 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02031991
• Other Study ID Numbers: B7391001; REFLECTIONS B739-01
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Pfizer
• Original Responsible Party: Same as current
• Current Study Sponsor: Pfizer
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: August 2014