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Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
---|---|
Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00806819 |
The trial will be performed to evaluate if BIBF 1120 in combination with standard pemetrexed therapy is more effective than placebo (inactive capsule) plus standard pemetrexed therapy in patients with stage IIIB, IV or recurrent NSCLC. Safety information about BIBF1120/pemetrexed will be obtained.
Condition | Intervention | Phase |
---|---|---|
Carcinoma, Non-Small-Cell Lung |
Drug: BIBF 1120 Drug: placebo Drug: pemetrexed |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized Double-Blind Multicenter Phase III Trial of BIBF 1120 Plus Pemetrexed vs. Pemetrexed/ Placebo in Advanced or Recurrent Non Small Cell Lung Cancer Patients After Failure of First Line Therapy |
Estimated Enrollment: | 1302 |
Study Start Date: | December 2008 |
Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Boehringer Ingelheim Study Coordinator | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
Responsible Party: | Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair ) |
Study ID Numbers: | 1199.14, Eudra CT :2008-002072-10 |
Study First Received: | December 10, 2008 |
Last Updated: | April 23, 2009 |
ClinicalTrials.gov Identifier: | NCT00806819 History of Changes |
Health Authority: | Argentina: Ministry of Health; Australia: Dept of Health and Ageing Therapeutic Goods Admin; Bosnia: Federal Ministry of Health; Brazil: National Health Surveillance Agency; Canada: Health Canada; Chile: Instituto de Salud Publica de Chile; Columbia: Instituto Nacional de Vigilancia de Medicamentos y Alimentos; Ecuador: Public Health Ministry; Hong Kong: Department of Health; Hungary: National Institute of Pharmacy; Ireland: Irish Medicines Board; Korea: Food and Drug Administration; Latvia: State Agency of Medicines; Macedonia: Ministry of Health; Malaysia: Ministry of Health; Mexico: Ministry of Health; Moldova: Ministry of Health; Netherlands: Ministry of Health, Welfare and Sport; New Zealand: Medsafe; Panama: Commemorative Institute GORGAS of Studies of Health; Peru: Ministry of Health; Philippines: Department of Health; Serbia and Montenegro: Agency for Drugs and Medicinal Devices; Taiwan: Department of Health; Thailand: Food and Drug Administration; Turkey: Ministry of Health; United States: Food and Drug Administration; Venezuela: Rafael Rangel National Institute of Health |
Thoracic Neoplasms Antimetabolites Folic Acid Antagonists Recurrence Carcinoma Pemetrexed Folic Acid |
Respiratory Tract Diseases Lung Neoplasms Lung Diseases Non-small Cell Lung Cancer Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
Antimetabolites Thoracic Neoplasms Respiratory Tract Neoplasms Antimetabolites, Antineoplastic Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Enzyme Inhibitors Folic Acid Antagonists Pharmacologic Actions |
Carcinoma Pemetrexed Neoplasms Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |