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| Sponsor: | Boehringer Ingelheim Pharmaceuticals |
|---|---|
| Information provided by (Responsible Party): | Boehringer Ingelheim Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00805194 |
Purpose
The present trial will be performed to evaluate whether BIBF 1120 in combination with standard therapy of docetaxel in patients with stage IIIB/IV or recurrent NSCLC is more effective as compared to placebo in combination with standard therapy of docetaxel. A secondary aim is to obtain safety information as well as information on quality of life of patients treated with BIBF 1120 in combination to standard therapy with docetaxel. In addition, blood will be collected for pharmacokinetic analysis.
| Condition | Intervention | Phase |
|---|---|---|
|
Carcinoma, Non-Small-Cell Lung |
Drug: BIBF 1120 plus docetaxel Drug: placebo plus docetaxel |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Multicentre, Randomised, Double-blind, Phase III Trial to Investigate the Efficacy and Safety of Oral BIBF 1120 Plus Standard Docetaxel Therapy Compared to Placebo Plus Standard Docetaxel Therapy in Patients With Stage IIIB/IV or Recurrent Non Small Cell Lung Cancer After Failure of First Line Chemotherapy |
| Estimated Enrollment: | 1300 |
| Study Start Date: | December 2008 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: BIBF 1120 plus docetaxel
BIBF 1120 2 times daily along with standard therapy of docetaxel
|
Drug: BIBF 1120 plus docetaxel
BIBF 1120 2 times daily along with standard therapy of docetaxel
|
|
Placebo Comparator: Placebo plus docetaxel
Placebo matching BIBF 1120 2 times daily along with standard therapy of docetaxel
|
Drug: placebo plus docetaxel
placebo matching BIBF 1120 2 times daily along with standard therapy of docetaxel
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Contacts and Locations
Show 226 Study Locations| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
| Responsible Party: | Boehringer Ingelheim Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00805194 History of Changes |
| Other Study ID Numbers: | 1199.13, 2007-004803-36 |
| Study First Received: | December 8, 2008 |
| Last Updated: | February 8, 2012 |
| Health Authority: | Austria: Agency for Health and Food Safety; Belarus: Ministry of Health of Republic of Belarus; Belgium: Federal Agency for Medicinal Products and Health Products; Bulgaria: Bulgarian Drug Agency; China: SDFA; Croatia: Ministry of Health and Social Welfare of the Republic of Croatia; Czech Republic: State Institute for Drug Control; Denmark: The Danish Medicines Agency; France: Afssaps - French Health Products Safety Agency; Georgia: Ministry of Health; Germany: Federal Institute for Drugs and Medical Devices; Great Britain: Medicines and Heathcare Products Regulatory Agency; Greece: Ministry of health & social solidarity national organization for medicines; India: Central Drug Standard Control Organization; Israel: Ministry of Health; Italy: The Italian Medicines Agency; Korea, Republic of: KFDA; Lithuania: Lithuanian Bioethics Committee; Poland: Agency for Registration of Medicinal Products, Medical Devices & Biocides; Portugal: National Pharmacy and Medicines Institute; Romania: National Medicines Agency; Russia: Federal Supervising Service for Public Health and Social Development of the Ministry of Health and Social Development of the Russian Federation; Slovakia: State Institute for Drug Control; South Africa: The Registrar, Department of Health, Medicines Control Council; Spain: Medicines and Healthcare Products Agency; Switzerland: Swissmedic; Ukraine: State Pharmacological Centre of Ministry of Health; United States: Food and Drug Administration |
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Carcinoma Carcinoma, Non-Small-Cell Lung Lung Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms |
Thoracic Neoplasms Neoplasms by Site Lung Diseases Respiratory Tract Diseases Docetaxel Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |