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PharmacokineticsPhase 1NCT04126044

A SINGLE-DOSE, 2-ARM, PHARMACOKINETIC STUDY OF PF-06439535 (CN) AND EUROPEAN UNION SOURCED BEVACIZUMAB IN CHINESE HEALTHY MALE VOLUNTEERS

A Phase 1 study testing PF-06439535 (CN) and bevacizumab - EU in people with Pharmacokinetics, run by Pfizer at 1 site in China.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This is a double-blind, randomized (1:1), parallel group, single dose, 2-arm, comparative PK study of PF-06439535 (CN) and bevacizumab-EU administered intravenously to Chinese healthy male volunteers. 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
Pharmacokinetics
What is being tested?
PF-06439535 (CN) and bevacizumab - EU
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteChina
Study dates
22 Jan 2021to 10 Jul 2021
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 Chinese male subjects who, at the time of screening, are between the ages of 21 55 years of age, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure (BP) and pulse rate (PR) measurement, 12 lead electrocardiogram (ECG), or clinical laboratory tests.
  • Subjects must have adequate organ function (excluding subjects who received blood transfusions) according to the following laboratory values: bone marrow function (absolute neutrophil count (ANC) >=1,500/mm3 and platelet count of 100,000/mm3), adequate liver function (alanine aminotransferase (ALT) <=3 times upper limit normal and alkaline phosphatase <= 2 times upper limit normal, total bilirubin <= 1.5 mg/dl), and adequate renal function (blood urea nitrogen (BUN)/urea <=1.5 times institutional normal and Creatinine <1.5 mg/dl) upon study entry.
  • Body Mass Index (BMI) of 18 to 28 kg/m2; and a total body weight >50 kg (110 lbs).
  • Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
  • Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Who cannot join

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
  • Evidence or history of heart failure, arterial or venous thromboembolism, bleeding diathesis, acquired coagulopathy or coagulopathy factor abnormality with international normalized ratio (INR) of >=1.5, or history of gross hemorrhage within the past 6 months prior to Screening (eg, hemoptysis or hematuria requiring medical intervention).
  • Evidence or history of relevant and clinically significant intra abdominal inflammation, gastrointestinal perforation or gall bladder perforation.
  • Major surgery or elective surgery within 3 months before or after administration of study treatment. At least 28 days should elapse from the time of minor surgical procedure, including placement of an access device and dental procedures.
  • Wounds that have not completely healed, active ulcer(s), or bone fracture(s).
  • Previous history of cancer, except for adequately treated basal cell or squamous cell carcinoma of the skin.
Show all 23Show fewer
  • Screening supine BP >= 140 mm Hg (systolic) or >= 90 mm Hg (diastolic) on a single measurement (confirmed by a single repeat, if necessary) following at least 5 minutes of rest. If BP is >= 140 mm Hg (systolic) or >= 90 mm Hg (diastolic), the BP should be repeated 2 more times and the average of the 3 BP values should be used to determine the subject's eligibility.
  • Clinically significant abnormalities in laboratory test results.
  • Screening supine 12 lead ECG demonstrating a corrected QT (QTc) interval >450 msec or a QRS interval >120 msec. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated 2 more times and the average of the 3 QTc or QRS values should be used to determine the subject's eligibility.
  • Fertile male subjects who are unwilling or unable to use highly effective methods of contraception as outlined in this protocol (refer to Section 4.4.4) for 71 days following study drug administration.
  • A positive urine drug test.
  • History of febrile illness within 5 days prior to dosing.
  • Current use of tobacco or nicotine containing products in excess of the equivalent of 5 cigarettes per day.
  • History of regular alcohol consumption exceeding 14 drinks/week (1 drink = 5 ounces [150 mL] of wine or 12 ounces [360 mL] of beer or 1.5 ounces [45 mL] of hard liquor) within 6 months of Screening.
  • History of serious allergic or anaphylactic reaction to a therapeutic drug.
  • Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of investigational product (whichever is longer).
  • Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose of investigational product. Use of anti platelet therapy eg, non steroidal anti inflammatory drugs (NSAIDs) is excluded. Herbal supplements must be discontinued 28 days prior to the first dose of investigational product. As an exception, acetaminophen/paracetamol may be used at doses of <=1 g/day. Limited use of non prescription medications that are not believed to affect subject safety or the overall results of the study may be permitted on a case by case basis, following approval by the sponsor.
  • Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing.
  • History of sensitivity to heparin or heparin induced thrombocytopenia.
  • Unwilling or unable to comply with the criteria in the Lifestyle Requirements section of this protocol.
  • History of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HepBsAg), hepatitis B core antibody (HepBcAb), or hepatitis C antibody (HCVAb).
  • Subjects who are investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.
  • Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Huashan Hospital,Fudan University

    Shanghai, Shanghai Municipality, 201107

Other trials in China

About this study

Official title: A DOUBLE BLIND, RANDOMIZED, PARALLEL-GROUP, SINGLE-DOSE, 2-ARM, COMPARATIVE PHARMACOKINETIC STUDY OF PF-06439535 (CN) AND BEVACIZUMAB SOURCED FROM EUROPEAN UNION ADMINISTERED TO CHINESE HEALTHY MALE VOLUNTEERS

This is a double-blind, randomized (1:1), parallel group, single dose, 2-arm, comparative PK study of PF-06439535 (CN) and bevacizumab-EU administered intravenously to Chinese healthy male volunteers. Approximately 66 subjects will be enrolled to ensure that at least 58 subjects (29 per arm) complete the study procedures and have evaluable PK data. The study will be conducted at 1 center in China.

Being tested
PF-06439535 (CN), bevacizumab - EU
Keywords
Pharmacokinetics

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PF-06439535 (CN)Drug

    This is the test drug Pfizer biosimilar of bevacizumab-EU.

  • bevacizumab - EUDrug

    This is the reference drug bevacizumab sourced from EU

Study groups in NCT04126044
Study groupRoleWhat they receive
Reference: bevacizumab - EUActive comparatorNot described
Receives: Drug: bevacizumab - EU
Test: PF-06439535 (CN)ExperimentalNot described
Receives: Drug: PF-06439535 (CN)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. AUC0-t (Area under the serum concentration-time profile from time 0 to last time point with quantifiable concentration)

    Measured: From Day 1 to Day 71

Secondary outcomes (9)

  1. Cmax (Maximum observed concentration derived from serum)

    Measured: From Day 1 to Day 71

  2. AUCinf (Area under the serum concentration-time profile from time zero extrapolated to infinity)

    Measured: From Day 1 to Day 71

  3. terminal half-life (t1/2)

    Measured: From Day 1 to Day 71

  4. clerance (CL)

    Measured: From Day 1 to Day 71

  5. steady state volume of distribution (Vss)

    Measured: From Day 1 to Day 71

  6. Percentage of participants with treatment emergent adverse events

    Measured: From screening until Day 71 (total period of approximately 99 days)

  7. Percentage of participants with clinical laboratory test results above/below certain threshold

    Measured: At screening; Days -1, 2, 8, 29, 71

  8. Incidence of anti-drug antibodies (ADA)

    Measured: From day 1 to day 71

  9. Incidence of neutralizing antibodies (Nab)

    Measured: From Day 1 to Day 71

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Oct 2019
  2. Study start22 Jan 2021 (estimated)
  3. Primary completion10 Jul 2021 (estimated)
  4. Study completion10 Jul 2021 (estimated)

Why it stopped: The study was withdrawn prior to enrollment after a comprehensive review of the biosimilars market and the company's global manufacturing network.

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04126044
Sponsor's protocol ID
B7391005
Status last verified
Apr 2021
First submitted
26 Sep 2019
Last updated
27 Apr 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PF-06439535 (CN) and bevacizumab - EU in people with Pharmacokinetics, run by Pfizer at 1 site in China.

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 5 inclusion and 23 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: withdrawn, as of the sponsor's last update on 27 Apr 2021. 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 China. 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 was withdrawn before enrolling participants, so there are no results.

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?

AUC0-t (Area under the serum concentration-time profile from time 0 to last time point with quantifiable concentration) (time frame: From Day 1 to Day 71). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04126044.

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 27 Apr 2021.

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