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A phase 2/3 trial to evaluate safety and efficacy of DEP® SN38 in patients with platinum-resistant ovarian cancer

Trial Profile

A phase 2/3 trial to evaluate safety and efficacy of DEP® SN38 in patients with platinum-resistant ovarian cancer

Status: Planning
Phase of Trial: Phase II/III

Latest Information Update: 24 Feb 2025

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At a glance

  • Drugs Irinotecan (Primary) ; Doxorubicin liposomal; Paclitaxel; Topotecan
  • Indications Ovarian cancer
  • Focus Adverse reactions; Therapeutic Use

Most Recent Events

  • 24 Feb 2025 According to a Starpharma media release, the company announced that ,the FDA agreed with Starpharmas proposal that DEP SN38 could be considered for FDA Fast Track designation, also the FDA indicated that DEP SN38 may qualify for accelerated approval based on an interim analysis of early surrogate endpoints from this proposed Phase 2/3 clinical trial program.
  • 24 Feb 2025 According to a Starpharma media release, the company to day announced that a positive development regarding its DEP SN38 (DEP irinotecan) program following a meeting with the US Food and Drug Administration (FDA), the purpose of the meeting was to confirm the regulatory approval pathways and seek regulatory guidance on the design of a Phase 2/3 clinical program aimed at obtaining registration for DEP SN38 in patients with platinum-resistant ovarian cancer in the US.
  • 24 Feb 2025 New trial record

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