NGR015: Randomized Double-blind Phase III Study of NGR-hTNF Plus Best Investigator's Choice (BIC) Versus Placebo Plus BIC in Previously Treated Patients With Advanced Malignant Pleural Mesothelioma (MPM).

Trial Profile

NGR015: Randomized Double-blind Phase III Study of NGR-hTNF Plus Best Investigator's Choice (BIC) Versus Placebo Plus BIC in Previously Treated Patients With Advanced Malignant Pleural Mesothelioma (MPM).

Completed
Phase of Trial: Phase III

Latest Information Update: 23 Jun 2017

At a glance

  • Drugs NGR-TNF (Primary)
  • Indications Mesothelioma
  • Focus Registrational; Therapeutic Use
  • Sponsors MolMed
  • Most Recent Events

    • 23 Jun 2017 According to a MolMed media release, the company has officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Zafiride for the treatment of advanced malignant pleural mesothelioma.
    • 06 Dec 2016 According to a MolMed media release, company has filed a Conditional Marketing Authorisation (CMA) application with the European Medicines Agency (EMA) for NGRhTNF for the treatment of adult patients with advanced malignant pleural mesothelioma who progressed within six months after the first-line pemetrexed-based therapy based on this trial.
    • 11 Oct 2016 Results assessing patients reported outcomes and impact of LDH levels on the outcomes, presented at the 41st European Society for Medical Oncology Congress
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