Study E7080-703. Randomized Phase II study of E7080 in NSCLC

• Research type

  Research Study

• Full title

  A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of Oral E7080 in Addition to Best Supportive Care (BSC) versus BSC Alone in Patients with Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer Who Have Failed at Least Two Systemic Anticancer Regimens

• IRAS ID

  92693

• Contact name

  Christian Ottensmeier

• Sponsor organisation

  Eisai Inc

• Eudract number

  2011-002347-10

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  This is a clinical trial testing a new experimental drug, called E7080, in adult patients with an advance form of lung cancer called non-squamous non-small cell lung cancer (NSCLC). For this patient group, this study is being carried out to compare the effect of combining E7080 with the best supportive care versus placebo with the best supportive care. A Placebo is an inactive dummy drug that looks like the experimental drug but is not. This multicentre study to be conducted in many research sites around the World, will be double-blind in nature, meaning that neither the participants nor the study doctors will know which treatment the participants are receiving (either E7080 or Placebo) and participants will be assigned to their treatment group by randomisation (by chance like flipping a coin). The Researchers will assess whether E7080 is safe and tolerable, and will see whether it is effective as an anticancer therapy in addition to best supportive care. This study also involves laboratory testing on blood samples and tissue samples to find out as much as possible on a biochemical/biological level about how E7080 might affect this advanced lung cancer.

• REC name

  South Central - Hampshire A Research Ethics Committee

• REC reference

  11/SC/0481

• Date of REC Opinion

  5 Dec 2011

• REC opinion

  Further Information Favourable Opinion