Gem/Cis with or without SAR240550, a PARP1 inhibitor,in stage IV NSCLC

• Research type

  Research Study

• Full title

  Randomised phase 2 study of gemcitabine/cisplatin with or without SAR240550 (BSI-201), a PARP1 inhibitor, in patients with stage IV non-small cell lung cancer.

• IRAS ID

  46224

• Contact name

  Andrew Hughes

• Sponsor organisation

  SANOFI-AVENTIS

• Eudract number

  2009-017270-21

• Research summary

  The main aim of the study is to investigate the anti-cancer activitiy of SAR240550 when given in combination with standard chemotherapy (Gemcitabine/Cisplatin) compared to standard chemotherapy alone in patients with stage IV non-small cell lung cancer (NSCLC) who have had no previous treatment for the disease. Lung cancer is one of the commonest cancer in the world and NSCLC accounts for approximately 80% of lung cancer cases. The majority of lung cancer patients present late when surgery is no longer a treatment option. The initial treatment for stage IV NSCLC patients is a combination chemotherapy regimen containing platinum compound of which Gemcitabine/Cisplatin combination is widely prescribed. In combination, both drugs help in the treatment of cancer by causing damage to deoxyribonucleic acid (DNA) of cancer cells (cytotoxic effect). SAR240550 is an investigational product which inhibit PARP1, a critical enzyme involved in DNA repair. Therefore, addition of SAR240550 is predicted to potentiate the cytotoxic effects of Gemcitabine/Cisplatin combination.

• REC name

  East of Scotland Research Ethics Service REC 2

• REC reference

  10/S0501/24

• Date of REC Opinion

  21 Apr 2010

• REC opinion

  Favourable Opinion