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Phase III trial for advanced ovarian cancer

Efficacy and safety of BIBF 1120 in combination with carboplatin and paclitaxel compared to placebo plus carboplatin and paclitaxel  for advanced ovarian cancer

At the time of diagnosis of ovarian cancer, more than two-thirds of women present with advanced stage disease (FIGO stage IIb - IV). Despite aggressive frontline therapy and high initial response rates, more than 50% of women with ovarian carcinoma will relapse and develop drug-resistant disease.  The proportion of patients experiencing relapse may reach 70 - 85% for patients with advanced disease (FIGO stage III and stage IV).

BIBF 1120 is a potent, experimental oral compound with triple kinase inhibitor targeting angiogenesis (or growth of blood vessels feeding the tumor), crucial for any tumor lesion to grow.

Objective
To investigate the efficacy and safety of BIBF 1120 plus chemotherapy as compared to placebo plus chemotherapy in women with advanced ovarian cancer

Method
This is a multicenter, randomised, double-blind placebo-controlled, parallel-group Phase III trial. The study is designed to compare BIBF 1120 plus chemotherapy versus placebo plus chemotherapy in patients with histologically proven epithelial ovarian cancer, fallopian tube or primary peritoneal cancer of advanced stage (FIGO IIB - IV). 

Eligible participants have had either prior debulking surgery or, if debulking surgery in stage IV was considered not appropriate, diagnosis confirmed by histology and no planned surgery prior to disease progression.

Principal Investigator: Dr. Lucy Gilbert  profile
Co-Investigators: Dr. Giovanni Artho, Dr. Josee Dubuc-Lissoir, Dr. Jaroslav Prchal, Dr. Jorge Tapia, Dr. Frederik Peeters

Study funded by: Boehringer Ingelheim  website

Study Coordinator: Natacha Albarracin 514-934-1934 x 31975