An Open, Randomized, Multicenter Study in Patients With Recurrent Epithelian Cancer, Primary Peritoneal Cancer or Fallopian Tube Cancer to Compare the Efficay and Safety of Paclitaxel (Micellar) Nanoparticles and Paclitaxel (Cremophor EL)

Trial Profile

An Open, Randomized, Multicenter Study in Patients With Recurrent Epithelian Cancer, Primary Peritoneal Cancer or Fallopian Tube Cancer to Compare the Efficay and Safety of Paclitaxel (Micellar) Nanoparticles and Paclitaxel (Cremophor EL)

Completed
Phase of Trial: Phase III

Latest Information Update: 08 Jun 2018

At a glance

  • Drugs Paclitaxel (Primary) ; Carboplatin
  • Indications Fallopian tube cancer; Ovarian cancer; Peritoneal cancer
  • Focus Adverse reactions; Biomarker; Pharmacogenomic; Registrational; Therapeutic Use
  • Sponsors Oasmia Pharmaceutical
  • Most Recent Events

    • 08 Jun 2018 According to an Oasmia Pharmaceutical media release, the company did not receive the recommendation for approval of Apealea at the CHMP meeting in April. The authority came back with a new question after referral from all member countries. The company was given 60 days to answer. The company does not see this new question as an obstacle to gain approval.
    • 05 Jun 2018 Results (n=789) presented at the 54th Annual Meeting of the American Society of Clinical Oncology.
    • 05 Jun 2018 Results presented in an Oasmia Pharmaceutical Media Release.
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