NCT02469987

Brief Summary

Double-blind, single-dose, three-treatment, parallel group design PK comparability study of MYL-1402O solution manufactured for Mylan compared to US and EU marketed Avastin® solution (bevacizumab).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
111

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Apr 2015

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 3, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 12, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

March 25, 2022

Status Verified

March 1, 2022

Enrollment Period

6 months

First QC Date

June 3, 2015

Last Update Submit

March 9, 2022

Conditions

Healthy

Keywords

safetytolerabilityimmunogenicityMYL-1402OPKAvastin®biosimilaritymale

Outcome Measures

Primary Outcomes (1)

  • Area under the plasma concentration versus time curve (AUC) for bevacizumab.

    Area under the plasma concentration versus time curve (AUC) for bevacizumab

    pre-dose and 0.33, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504, 672, 1008, 1344, 1680, 2016, and 2352 hours after start of infusion.

Secondary Outcomes (1)

  • Area under the plasma concentration versus time curve (AUC) for bevacizumab

    pre-dose and 0.33, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504, 672, 1008, 1344, 1680, 2016, and 2352 hours after start of infusion.

Other Outcomes (2)

  • Number of Participants with Adverse Events

    up to 99 days.

  • Safety variable - immunogenicity

    Predose day 1, and days 15, 43, 71, and 99 post infusion

Study Arms (3)

MYL-1402O

EXPERIMENTAL

MYL-1402O (bevacizumab), single 1mg/kg i.v. infusion over 90 minutes.

Drug: MYL-1402O

US Marketed Avastin (R)

ACTIVE COMPARATOR

US Marketed Avastin(R) (bevacizumab), single 1mg/kg i.v. infusion over 90 minutes.

Drug: US marketed Avastin(R)

EU Marketed Avastin(R)

ACTIVE COMPARATOR

EU Marketed Avastin(R) (bevacizumab), single 1mg/kg i.v. infusion over 90 minutes.

Drug: EU marketed Avastin(R)

Interventions

MYL-1402ODRUG

Treatment A - single 1mg/kg dose of MYL-14020 IV infusion over 90 mins.

Also known as: Bevacizumab
MYL-1402O
US marketed Avastin(R)DRUG

Treatment B - single 1mg/kg dose of US marketed Avastin® IV infusion over 90mins

Also known as: Bevacizumab
US Marketed Avastin (R)
EU marketed Avastin(R)DRUG

Treatment C - single 1mg/kg dose of EU marketed Avastin® IV infusion over 90mins.

Also known as: Bevacizumab
EU Marketed Avastin(R)

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Males aged 18-55 yrs. (inclusive)
  • BMI: 19.0 to 30.0 kg/m2 (inclusive)
  • Weight: ≥ 60kg and ≤100kg
  • Subjects should be willing to use adequate contraception and not donate sperm from admission to clinical research center until 6 months post dosing.
  • All intermittent medications should have be stopped at least 14days prior to admission to the clinical research center.
  • All intermittent non topical medication must be stopped at least 30days prior to admission to the clinical research center.
  • Ability and willingness to abstain from ETOH 48hrs prior to admission to the clinical research center.
  • Medical history without significant findings per the PI
  • Resting supine systolic BP of ≤140mmHg and diastolic BP of ≤90mmHg
  • ECGs (via 12 lead) showing NCS findings per PI
  • All clinical laboratory tests of blood and urine, WNL and/or without clinically significant findings
  • Willing/able to sign ICF
  • Normal bowel habits
  • Negative medical history regarding fecal blood positivity
  • Normal and/or NCS spot protein/creatinine (PCR) ratio.

You may not qualify if:

  • Previous participation in the current study
  • History of prior exposure to bevacizumab
  • Evidence of clinically significant findings
  • Cognitive and / or mentally impaired handicaps that would affect ability to make an informed consent and/or remain compliant to the requirements of this trial.
  • History of relevant drug and/or food related allergies.
  • History of or known hypersensitivity to bevacizumab or other recombinant human or humanized antibodies or inactive ingredients.
  • Tobacco product use w/I 1 yr. prior to drug administration.
  • History of ETOH and or drug abuse/addiction
  • Positive urine drug and ETOH screen for opiates, methadone, cocaine, amphetamines including XTC, cannabinoids, barbiturates, benzodiazepines, tricyclic antidepressants and ETOH.
  • Average intake of more than 24 units of ETOH / wk. (1 unit of ETOH equals \~250mL of beer, 100mL of wine or 35mL of spirits).
  • Consumption of any foods containing poppy seeds w/I 48 hrs. prior to screening and admission to the clinical research center
  • Positive screen for Hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies or anti-human immunodeficiency virus (HIV) 1 and 2 antibodies.
  • Participation in a drug study w/I 60days or 5 half-lives of the previous drug.
  • Participation in more than 3 other drug studies in the 10months prior to drug administration in the current protocol.
  • Donation or loss of more than 100mL of blood w/I 60days prior to drug administration. Donation or loss of more than 1.5liters of blood w/I the 10months prior to drug administration.
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PRA Health Sciences - Early Development Services

Zuidlaren, 9471 GP, Netherlands

Location

Related Publications (1)

  • Hummel M, Bosje T, Shaw A, Liu MS, Barve A, Kothekar M, Socinski MA, Waller CF. A pharmacokinetics study of proposed bevacizumab biosimilar MYL-1402O vs EU-bevacizumab and US-bevacizumab. J Cancer Res Clin Oncol. 2022 Feb;148(2):487-496. doi: 10.1007/s00432-021-03628-0. Epub 2021 Apr 17.

    PMID: 33866430DERIVED

MeSH Terms

Interventions

Bevacizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Matthew A. Hummel, PhD

    Mylan Pharmaceuitcals Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2015

First Posted

June 12, 2015

Study Start

April 1, 2015

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

March 25, 2022

Record last verified: 2022-03

Locations

NL(1)