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A Phase IIb/III pivotal study of Lipax for the treatment of Non-Muscle Invasive Bladder Cancer

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Trial Profile

A Phase IIb/III pivotal study of Lipax for the treatment of Non-Muscle Invasive Bladder Cancer

Status: Planning
Phase of Trial: Phase II/III

Latest Information Update: 15 Jun 2021

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At a glance

  • Drugs Paclitaxel (Primary)
  • Indications Bladder cancer
  • Focus Registrational; Therapeutic Use
  • Sponsors LIPAC Oncology

Most Recent Events

  • 09 Jun 2021 The U.S. Food and Drug Administration (FDA) has agreed on Phase 2b and Phase 3 trial designs, with the Phase 2b trial expected to initiate in Q4 2021.
  • 29 Apr 2021 According to a LIPAC Oncology media release, the company had a successful type B meeting with FDA that discussed hase 2b/3 clinical trials of LiPax in patients with low-grade highly recurrent non-muscle invasive bladder cancer (NMIBC). The feedback from the FDA provides a clear path for LIPAC Oncology to initiate the Phase 2b trial for LiPax in the second half of 2021.
  • 29 Apr 2021 According to a LIPAC Oncology Media Release, the FDA agreed that the Phase 2b trial will be a dose selection study with low dose (90 mg) and high dose (360 mg) arms and will enroll approximately 30 patients in each arm. The Phase 3 trial will be a randomized, double-blind, placebo-controlled trial in patients with low-grade recurrent NMIBC with a time to event primary endpoint after a one-year treatment phase.

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