NGR015 - secondline treatment for mesothelioma

• Research type

  Research Study

• Full title

  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)

• IRAS ID

  53042

• Contact name

  Mary O'Brien

• Sponsor organisation

  MOLMED

• Eudract number

  2009-016879-29

• ISRCTN Number

  na

• Clinicaltrials.gov Identifier

  NCT01098266

• Research summary

  There is currently no standard therapy for mesothelioma that has come back (relapsed) after treatment with pemetrexed and cisplatin treatment. NGR-hTNF is a new treatment that could be active in this situation. This study will compare overall survival, the period free from disease progression, and the percentage and duration of disease control (in subjects previously treated with pemetrexed) between the two treatment groups. An additional objective is to assess the safety and toxicity profile of the study drug NGR-hTNF and the quality of life in the 2 treatment groups. This clinical trial is randomized and double-blind which means treatment will be allocated by a computer program at random(like flipping a coin)and both patient and doctor will know be 'blind' to whether NGR-h TNF or placebo is being given. This is to prevent bias and be a true test of whether this new treatment works or not. All patients will receive the best chemotherapy currently available. The drugs that subjects may be administered are: ?½ NGR-hTNF or Placebo: NGR-hTNF, the main component of which is the Tumour Necrosis Factor (TNF), a cytokine with various effects on tumour blood vessels with antitumour action, or the Placebo, a substance without the active ingredient. ?½ Best supportive therapy in accordance with good clinical practice: e.g. antibiotics, analgesics, anti-sickness drugs, etc. ?½ Chemotherapy: subjects might receive one of the following chemotherapy agents, the ones best indicated for treating the disease: Doxorubicin, Gemcitabine Vinorelbine.In the case of response or stabilising of the disease and if side effects are acceptable, chemotherapy can be administered for a maximum of 6 cycles (usually 3 weekly). NGR-hTNF/placebo injections can be continued weekly after completion of chemotherapy as long as the patient and doctor agree that they are useful in some way.

• REC name

  London - Brent Research Ethics Committee

• REC reference

  11/LO/0054

• Date of REC Opinion

  18 Apr 2011

• REC opinion

  Further Information Favourable Opinion