1199.15: BIBF 1120 in ovarian cancer

• Research type

  Research Study

• Full title

  Multicenter, randomised, double-blind, Phase III trial to investigate the efficacy and safety of BIBF 1120 in combination with standard treatment of carboplatin and paclitaxel compared to placebo plus carboplatin and paclitaxel in patients with advanced ovarian cancer

• IRAS ID

  28477

• Contact name

  Agnieszka Michael

• Sponsor organisation

  Boehringer Ingelheim Ltd

• Eudract number

  2008-006831-10

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  The primary objective of this study is to investigate the efficacy and safety of BIBF 1120 plus chemotherapy as compared to placebo plus chemotherapy in patients with advanced ovarian cancer. BIBF 1120 is a potent small molecule drug that inhibits the growth of blood vessels within the tumours. It has previously been combined with chemotherapy agents and showed a good safety and efficacy. Ovarian cancer patients usually present at a late stage and following optimal treatment majority of patients relapse. Time to disease relapse varies but it can be very short ranging from a few weeks to several years. Drugs inhibiting blood vessel growth (anti-angiogenic) are very promising and in combination with standard chemotherapy agents will hopefully have an impact on the disease progression. The main measure of drug efficacy will be progression free survival, ie., time from date of randomisation to date of progression or death, which ever comes earlier.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  09/H0703/104

• Date of REC Opinion

  23 Dec 2009

• REC opinion

  Further Information Favourable Opinion