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| Sponsor: | Boehringer Ingelheim Pharmaceuticals |
|---|---|
| Information provided by (Responsible Party): | Boehringer Ingelheim Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01015118 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Ovarian Neoplasms Peritoneal Neoplasms |
Drug: BIBF 1120 Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | 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 |
| Estimated Enrollment: | 1300 |
| Study Start Date: | November 2009 |
| Estimated Primary Completion Date: | July 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: BIBF 1120
patients to receive BIBF 1120 standard dose twice daily PO in combination with combination with carboplatin and paclitaxel
|
Drug: BIBF 1120
comparison of BIBF 1120 in combination with chemotherapy and placebo in combination with chemotherapy (paclitaxel/carboplatin)
|
|
Placebo Comparator: Placebo
patients to receive capsules identical to those containing BIBF 1120 in combination with combination with carboplatin and paclitaxel
|
Drug: Placebo
comparator to BIBF 1120
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Contacts and Locations
Show 293 Study Locations| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
| Responsible Party: | Boehringer Ingelheim Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01015118 History of Changes |
| Other Study ID Numbers: | 1199.15, AGO-OVAR12, 2008-006831-10 |
| Study First Received: | November 9, 2009 |
| Last Updated: | May 2, 2012 |
| Health Authority: | Australia: Human Research Ethics Committee Austria: Federal Office for Safety in Health Care Belgium: Federal Agency for Medicinal and Health Products Canada: Czech Republic: State Institute for Drug Control Denmark: Danish Medicines Agency Finland: Finnish Medicines Agency France: Afssaps - French Health Products Safety Agency Germany: Federal Institute for Drugs and Medical Devices Greece: Ethics Committee Italy: Ethics Committee Netherlands: Central Committee Research Involving Human Subjects Norway: Norwegian Medicines Agency Poland: Registration Medicinal Product Medical Device Biocidal Product Portugal: National Pharmacy and Medicines Institute Russia: Pharmacological Committee, Ministry of Health Slovakia: State Institute for Drug Control Spain: Spanish Agency of Medicines Sweden: Medical Products Agency Ukraine: State Pharmacological Center - Ministry of Health United Kingdom: Medicines and Healthcare Products Regulatory Agency United States: Food and Drug Administration |
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Neoplasms Ovarian Neoplasms Peritoneal Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Abdominal Neoplasms |
Digestive System Neoplasms Digestive System Diseases Peritoneal Diseases Carboplatin Paclitaxel Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic |