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A Randomized, Open-Label, 2-Arm, Parallel Group, Single Dose, Multi-Centre Study in Healthy Male Subjects to Investigate the Comparability of Pharmacokinetics of the Fixed-Dose Combination of Pertuzumab and Trastuzumab Administered Subcutaneously Using a Handheld Syringe or Using the On-Body Delivery System

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Trial Profile

A Randomized, Open-Label, 2-Arm, Parallel Group, Single Dose, Multi-Centre Study in Healthy Male Subjects to Investigate the Comparability of Pharmacokinetics of the Fixed-Dose Combination of Pertuzumab and Trastuzumab Administered Subcutaneously Using a Handheld Syringe or Using the On-Body Delivery System

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 08 May 2025

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At a glance

  • Drugs Pertuzumab/trastuzumab (Primary)
  • Indications Colorectal cancer; HER2 positive breast cancer; Male breast cancer; Solid tumours
  • Focus Pharmacokinetics
  • Sponsors Roche

Most Recent Events

  • 30 Apr 2025 According to Roche media release, the European Medicines Agencys Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending an update to the European Union (EU) label for Phesgo, a subcutaneous (SC) fixed-dose combination of Perjeta (pertuzumab) and Herceptin (trastuzumab), for human epidermal growth factor receptor 2 (HER2)-positive breast cancer, A final decision regarding the approval is expected from the European Commission in the near future.
  • 19 Oct 2023 Status changed from active, no longer recruiting to completed.
  • 27 Mar 2023 Planned End Date changed from 17 Sep 2023 to 15 Oct 2023.

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