NCT01015118

LUME-Ovar 1: Nintedanib (BIBF 1120) or Placebo in Combination With Paclitaxel and Carboplatin in First Line Treatment of Ovarian Cancer

Multicenter, Randomised, Double-blind Phase III Trial to Investigate the Efficacy and Safety of BIBF 1120 in Combination With Carboplatin and Paclitaxel Compared to Placebo Plus Carboplatin and Paclitaxel in Patients With Advanced Ovarian Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,366 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The trial will be performed to evaluate if BIBF 1120 in combination with paclitaxel and carboplatin is more effective than placebo in combination with paclitaxel and carboplatin in first-line treatment of patients with advanced ovarian cancer. Safety information about BIBF1120/paclitaxel/carboplatin will be obtained.

Conditions

• Ovarian Neoplasms
• Peritoneal Neoplasms

Interventions

Type	Name	Description
DRUG	Placebo	comparator to BIBF 1120
DRUG	Paclitaxel	Paclitaxel (standard chemo-therapy)
DRUG	BIBF 1120	comparison of BIBF 1120 in combination with chemotherapy and placebo in combination with chemotherapy (paclitaxel/carboplatin)
DRUG	Carboplatin	Carboplatin (standard chemo-therapy)
DRUG	Paclitaxel	Paclitaxel (standard chemo-therapy)
DRUG	Carboplatin	Carboplatin (standard chemo-therapy)

Timeline

• Start date: 2009-11-17
• Primary completion: 2013-04-01
• Completion: 2016-09-15
• First posted: 2009-11-18
• Last updated: 2017-12-07
• Results posted: 2015-01-15

Locations

281 sites across 22 countries: United States, Australia, Austria, Belgium, Canada, Czechia, Denmark, Finland, France, Germany, Greece, Italy, Netherlands, Norway, Poland, Portugal, Russia, Slovakia, Spain, Sweden, Ukraine, United Kingdom