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A Single Center, Randomized, Double-blind, 3-arm Parallel Phase1 Study to Assess PK, Safety, and Tolerability of a Single 90 Min iv Infusion of 1 mg/kg MYL-1402O, EU Avastin, and US Avastin in Healthy Male Volunteers

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A Single Center, Randomized, Double-blind, 3-arm Parallel Phase1 Study to Assess PK, Safety, and Tolerability of a Single 90 Min iv Infusion of 1 mg/kg MYL-1402O, EU Avastin, and US Avastin in Healthy Male Volunteers

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 06 Oct 2023

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At a glance

  • Drugs Bevacizumab (Primary)
  • Indications Breast cancer; Cervical cancer; CNS cancer; Colorectal cancer; Fallopian tube cancer; Glioblastoma; Non-small cell lung cancer; Ovarian cancer; Peritoneal cancer; Renal cancer; Renal cell carcinoma
  • Focus Pharmacokinetics
  • Sponsors Mylan

    • Most Recent Events

    • 04 Oct 2023 Results of pooled analysis (from studies NCT02469987 and NCT04633564) to establish a population pharmacokinetic model assessing to assess pharmacokinetic linearity of MYL-1402O and Avastin across dose ranges in patients with non-squamous non-small cell lung cancer published in the European Journal of Drug Metabolism and Pharmacokinetics
    • 01 Feb 2022 Primary endpoint has been met (Bioequivalence of EU-reference bevacizumab to US-reference bevacizumab), as per results published in the Journal of Cancer Research and Clinical Oncology
    • 01 Feb 2022 Status changed from active, no longer recruiting to completed, as per results published in the Journal of Cancer Research and Clinical Oncology

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