HealthyPhase 1NCT02031991
A Pharmacokinetic Study Comparing PF-06439535 And Bevacizumab In Healthy Male Volunteers (REFLECTIONS B739-01)
A Phase 1 study testing PF-06439535 and Avastin in people with Healthy, run by Pfizer at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- PF-06439535 and Avastin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Aug 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Pfizer Investigational Site
South Miami, Florida, 33143
About this study
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
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
- Being tested
- PF-06439535, Avastin
- Keywords
- Bioequivalence, Biosimilarity, Similarity, PK, Phase 1, Bevacizumab, Healthy Volunteers, Single-Dose, Oncology
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-06439535Biological
Also called PF-06439535, a potential biosimilar to bevacizumab
Solution for intravenous infusion, single dose of 5mg/kg, administered as 90-minute infusion.
AvastinBiological
Also called Bevacizumab (European Union)
Solution for intravenous infusion, single dose of 5mg/kg, administered as 90-minute infusion.
AvastinBiological
Also called Bevacizumab (United States)
Solution for intravenous infusion, single dose of 5mg/kg, administered as 90-minute infusion.
| Study group | Role | What they receive |
|---|---|---|
| A = PF-06439535 | Experimental | Intervention Description: Sterile vial 400mg, single-dose 5mg/kg administered as 90-minute infusion on day 1. Receives: 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. Receives: Biological: Avastin |
| C = Bevacizumab-US | Active comparator | Intervention Description: Sterile vial 400mg, single-dose 5mg/kg administered as 90-minute infusion on day 1. Receives: Biological: Avastin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax)
Measured: Day 1 - Day 71
Area Under the Curve from Time Zero to end of dosing interval (AUCtau)
Measured: 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).
Measured: Day 1 - Day 71
Secondary outcomes (4)
Systemic Clearance (CL)
Measured: Day 1 - Day 71
Terminal Disposition Half-Life (t1/2)
Measured: Day 1 - Day 71
Volume of Distribution at Steady State (Vss)
Measured: Day 1 - Day 71
Incidence of anti-bevacizumab antibodies (ADA), including neutralizing antibodies (Nab)
Measured: Day 1 - Day 71 or LSLV, whichever occurs later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02031991
- Sponsor's protocol ID
- B7391001
- Other IDs
- REFLECTIONS B739-01
- Status last verified
- Aug 2014
- First submitted
- 7 Jan 2014
- Last updated
- 15 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02031991
- Acronym / sponsor ID
- B7391001
- Conditions
- Healthy
- Keywords
- Bioequivalence, Biosimilarity, Similarity, PK, Phase 1, Bevacizumab, Healthy Volunteers, Single-Dose
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 9 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A = PF-06439535 | Experimental | Biological: PF-06439535Intervention Description: Sterile vial 400mg, single-dose 5mg/kg administered as 90-minute infusion on day 1. |
| B = Bevacizumab-EU | Active comparator | Biological: AvastinIntervention Description: Sterile vial 400mg, single-dose 5mg/kg administered as 90-minute infusion on day 1. |
| C = Bevacizumab-US | Active comparator | Biological: AvastinIntervention Description: Sterile vial 400mg, single-dose 5mg/kg administered as 90-minute infusion on day 1. |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PF-06439535Also: PF-06439535, a potential biosimilar to bevacizumabSolution for intravenous infusion, single dose of 5mg/kg, administered as 90-minute infusion. | Biological | A = PF-06439535 |
| AvastinAlso: Bevacizumab (European Union)Solution for intravenous infusion, single dose of 5mg/kg, administered as 90-minute infusion. | Biological | B = Bevacizumab-EU |
| AvastinAlso: Bevacizumab (United States)Solution for intravenous infusion, single dose of 5mg/kg, administered as 90-minute infusion. | Biological | C = Bevacizumab-US |
Primary outcome
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).
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2014.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PF-06439535 and Avastin in people with Healthy, run by Pfizer at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Observed Plasma Concentration (Cmax) (time frame: Day 1 - Day 71). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2014.