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A Phase III, Single-arm Study to Evaluate the Efficacy and Safety of ONCOFID-P-B (Paclitaxel-hyaluronic Acid Conjugate) Administered Intravesically to Patients With BCG-unresponsive Carcinoma in Situ of the Bladder With or Without Ta-T1 Papillary Disease (Orion-BC)

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Trial Profile

A Phase III, Single-arm Study to Evaluate the Efficacy and Safety of ONCOFID-P-B (Paclitaxel-hyaluronic Acid Conjugate) Administered Intravesically to Patients With BCG-unresponsive Carcinoma in Situ of the Bladder With or Without Ta-T1 Papillary Disease (Orion-BC)

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 13 May 2024

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At a glance

  • Drugs Paclitaxel-hyaluronic acid conjugate (Primary)
  • Indications Bladder cancer
  • Focus Registrational; Therapeutic Use
  • Sponsors Fidia Farmaceutici
  • Most Recent Events

    • 18 Jan 2023 Status changed from not yet recruiting recruiting.
    • 18 Jan 2023 Planned End Date changed from 1 Jul 2027 to 1 Nov 2027.
    • 18 Jan 2023 Planned primary completion date changed from 1 Jul 2025 to 1 Nov 2025.

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