1199.93 - Nintedanib in mesothelioma

• Research type

  Research Study

• Full title

  Double blind, randomised, multicentre, phase II study of nintedanib in combination with pemetrexed / cisplatin followed by continuing nintedanib monotherapy versus placebo in combination with pemetrexed / cisplatin followed by continuing placebo monotherapy for the treatment of patients with unresectable malignant pleural mesothelioma.

• IRAS ID

  126972

• Contact name

  Sanjay Popat

• Contact email

  sanjay.popat@rmh.nhs.uk

• Eudract number

  2012-005201-48

• Duration of Study in the UK

  2 years, 9 months, 3 days

• Research summary

  This is a randomised, double-blind, placebo-controlled trial to evaluate the efficacy and safety profile of nintedanib + standard chemotherapy (pemetrexed/cisplatin) followed by nintedanib monotherapy (Arm A), compared to placebo + standard chemotherapy (pemetrexed/cisplatin) followed by placebo monotherapy (Arm B) in patients with malignant pleural mesothelioma. All eligible patients will receive nintedanib or placebo until disease progression. There will also be exploratory analyses of biomarkers in tumour tissue and blood to assist in the evaluation of molecular markers and possible correlation with treatment.

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  13/LO/0867

• Date of REC Opinion

  21 Jun 2013

• REC opinion

  Favourable Opinion