LUME-Ovar 1: Nintedanib (BIBF 1120) or Placebo in Combination With Paclitaxel and Carboplatin in First Line Treatment of Ovarian Cancer
NCT01015118 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1366
Last updated 2017-12-07
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
- DRUG
-
comparator to BIBF 1120
- DRUG
-
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 (standard chemo-therapy)
- DRUG
-
Paclitaxel (standard chemo-therapy)
- DRUG
-
Carboplatin (standard chemo-therapy)
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Boehringer Ingelheim · Boehringer Ingelheim
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-11-17
- Primary Completion
- 2013-04-01
- Completion
- 2016-09-15
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
Study Locations
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