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A Phase I Study Comparing Pharmacokinetics and Safety of Bevacizumab

  • Clinicaltrials.gov identifier

    NCT03919448

  • Recruitment Status

    Completed

  • First Posted

    April 18, 2019

  • Last update posted

    February 19, 2020

Study Description

Brief summary:

The aim of the Clinical study is to evaluate the pharmacokinetic and safety profile of a new formulation of Bevacizumab (Zutrab®) when compared to two already marketed formulations Avastin® and Cizumab®, to establish similarity.

  • Condition or Disease:Pharmacokinetics
    Safety Issues
  • Intervention/Treatment: Biological: Bevacizumab
  • Phase: Phase 1

Detailed Description

Three-way bridge phase 1 trial. It is conducted in healthy, male adult subjects, it is single-dose, double-blind, parallel groups, randomized and balanced. Blood samples are collected up to 90 days, to dermine serum drug concentration and anti-drug antibodies. Safety and tolerabilty is also evaluated.

Study Design

  • Study Type: Interventional
  • Actual Enrollment: 90 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Other
  • Official Title: A Double-blind, Randomized, Balanced, Parallel Group, Phase I Study Comparing Pharmacokinetics and Safety of Bevacizumab
  • Actual Study Start Date: April 2019
  • Actual Primary Completion Date: September 2019
  • Actual Study Completion Date: September 2019

Arms and interventions

Arm Intervention/treatment
Active Comparator: Avastin®
a single 1 mg/kg IV dose of Bevacizumab
Biological: Bevacizumab
Single-dose infusion
Active Comparator: Cizumab®
a single 1 mg/kg IV dose of Bevacizumab
Biological: Bevacizumab
Single-dose infusion
Active Comparator: Zutrab® (Bevacizumab Richmond)
a single 1 mg/kg IV dose of Bevacizumab
Biological: Bevacizumab
Single-dose infusion

Outcome Measures

  • Primary Outcome Measures: 1. Peak serum concentration of bevacizumab (Cmax) [ Time Frame: Day 1 to Day 63 ]
    Cmax will be obtained directly from the serum concentration-time curve
  • 2. Area under the serum concentration-time curve of bevacizumab (ABC0-t) [ Time Frame: Day 1 to Day 63 ]
    Area under the serum concentration-time curve from time zero to the last experimental point, will be calculated by the trapezoidal rule
  • 3. Area under the serum concentration- time curve ob bevacizumab (ABC0-∞) [ Time Frame: Day 1 to Day 63 ]
    Area under the serum concentration- time curve from time zero to infinity
  • Secondary Outcome Measures: 1. Time to reach the peak serum concentration (Tmax) [ Time Frame: Day 1 to Day 63 ]
    Time to reach the peak serum concentration, which will be obtained directly from the serum concentration curve- time
  • 2. Terminal elimination rate constant (λz) [ Time Frame: Day 1 to Day 63 ]
    Terminal elimination rate constant will be calculated by linear regression analysis of the semi-logarithmic curve
  • 3. Elimination half life (T1/2) [ Time Frame: Day 1 to Day 63 ]
  • 4. Systemic Clearance (CL) [ Time Frame: Day 1 to Day 63 ]
  • 5. Distribution volume [ Time Frame: Day 1 to Day 63 ]
  • 6. Anti-bevacizumab serum antibodies detection (Immunogenicity) [ Time Frame: Screening and end of study (Day 63) ]
  • Other Outcome Measures: 1. Adverse Events [ Time Frame: 63 days ]
    Report the nature and incidence of adverse events and the eventual suspension or abandonment of the study or the participation of a study subject.

Eligibility Criteria

  • Ages Eligible for Study: 21 to 55 Years (Adult)
  • Sexes Eligible for Study: Male
  • Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

- Study subjects must be willing and able to provide written informed consent

- Subjects of study, volunteers, adults, healthy.

- Study subjects whose safety and complementary laboratory tests are within normal
values or which, in the Investigator's opinion, do not have clinical relevance: blood
count, erythrosedimentation, hepatogram, urea, creatinine, glucose, coagulogram,
serology for HIV, hepatitis B , hepatitis C, immunogenicity, complete urinalysis,
detection of drugs of abuse in urine and electrocardiogram.

- Body mass index between 19 and 27 kg / m2 at the screening visit.

- Subjects of study preferably non-smokers.

- Men with a partner of childbearing age must agree that their partner uses an adequate
contraceptive method before entering the study and for at least 3 months after the end
of the study. It is understood as a contraceptive method suitable to any hormonal
contraceptive method or intrauterine device (which should be established before the
start of the study) and the use of a spermicide as a barrier method. The use of a
barrier method alone or sexual abstinence is not considered adequate.

- Subjects must agree not to donate sperm during the study and for 4 months after
treatment.

Exclusion Criteria:

- History of pulmonary, gastrointestinal, hepatic, renal, hematological,
endocrine-metabolic, neurological or psychiatric illnesses (depressive disorders, in
particular) at the time of taking the anamnesis and the physical examination during
the first visit of the Protocol of Clinical research.

- History of gastrointestinal surgeries (except uncomplicated appendectomy, at least 3
months old).

- History of major surgery, surgical biopsy and / or history of significant trauma
within 1 month of the screening visit.

- Specifically, pre-existing gastrointestinal conditions such as abdominal fistulas,
gastrointestinal perforation within 6 months of the screening visit.

- Specifically, preexisting gastrointestinal conditions such as acute or subacute
intestinal occlusion.

- Specifically, history of inflammatory bowel disease.

- History of hemorrhagic diseases and / or coagulopathies and / or thromboembolic
events.

- History of heart and vascular diseases: specifically myocardial infarction, unstable
angina, cerebrovascular accident, uncontrolled arterial hypertension and cardiac
arrhythmias.

- Background or current history of alcohol or drug abuse.

- Blood donation within 3 months prior to selection.

- Administration of any other drug under investigation or participation in a clinical
research trial within 3 months prior to the planned participation in this Clinical
Research Protocol.

- History of clinically significant diseases or disorders that, in the opinion of the
Investigator, may impede the participation of the study subject for safety reasons or
that may influence the results of the same as well as the ability of the study subject
to participate in the Clinical Research Protocol.

- History of hypersensitivity to bevacizumab and / or any of the excipients.

- Study subjects who present contraindications to therapy

- Study subjects who have received (2 weeks before) or are receiving aspirin or
clopidogrel

- The study subjects must have suspended any pharmacological treatments at least 2 weeks
before the initiation of this Clinical Research Protocol.

- Non-cooperative study subjects

- Study subjects employed by the Researcher or the Clinical-Pharmacokinetic Research
Unit, with direct participation in the Clinical Research Protocol or other clinical
protocols under the Direction of the Researcher or the Clinical-Pharmacokinetic
Research Unit

- Physical findings and laboratory analyses:

- Cardiac, pulmonary, gastrointestinal, hepatic, renal, hematological,
endocrine-metabolic, neurological disease or psychiatric disorder (depressive
disorders, in particular)

- Evidence of ulcers, unhealed wounds or bone fractures.

- Clinically significant abnormalities in any laboratory analysis, and electrocardiogram

- Positive serology for HIV, hepatitis B, hepatitis C

- Positive result in immunogenicity test (serum antibodies anti-bevacizumab)

Contacts and Locations

Contacts

Locations

Argentina
FP Clinical Pharma S.R.L.
Buenos Aires

Sponsors and Collaborators

Laboratorios Richmond S.A.C.I.F.

FP Clinical Pharma S.R.L.

Syngene International Limited

Investigators

Principal Investigator: Ethel C Feleder, MD FP Clinical Pharma S.R.L.

More Information

  • Responsible Party: Laboratorios Richmond S.A.C.I.F.
  • ClinicalTrials.gov Identifier: NCT03919448 History of Changes
  • Other Study ID Numbers: 0221
  • First Posted: April 18, 2019 Key Record Dates
  • Last Update Posted: February 19, 2020
  • Last Verified: February 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:

  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Product Manufactured in and Exported from the U.S.: Yes
  • Keywords provided by Laboratorios Richmond S.A.C.I.F.: Antineoplasic Agents
    Bioequivalence
    Inmunogenicity
    healthy male volunteers
    safety
    Bevacizumab
    Biosimilar