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| Sponsor: | Amgen |
|---|---|
| Collaborator: |
Takeda Global Research & Development Center, Inc. |
| Information provided by: | Amgen |
| ClinicalTrials.gov Identifier: | NCT00460317 |
Purpose
To determine if treatment with AMG 706 in combination with paclitaxel and carboplatin improves overall survival compared to treatment with placebo in combination with paclitaxel and carboplatin in subjects with advanced non-squamous NSCLC and in subjects with adenocarcinoma histology (adenocarcinoma subpopulation).
| Condition | Intervention | Phase |
|---|---|---|
|
Non-Small Cell Lung Cancer |
Drug: AMG 706 Drug: placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Phase 3, Multicenter, Randomized, Placebo-Controlled, Double-Blind Trial of AMG 706 in Combination With Paclitaxel and Carboplatin for Advanced Non-small Cell Lung Cancer. |
| Enrollment: | 1450 |
| Study Start Date: | July 2007 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Arm B
All subjects on this treatment arm will receive a standard paclitaxel and carboplatin chemotherapy regimen (paclitaxel 200mg/m2 and carboplatin at AUC of 6mg/mL x min by Calvert formula) on day 1 of each 3 week cycle + - 3 days for a maximum of 6 cycles and placebo 125mg QD orally
|
Drug: placebo
125 mg QD orally every day
|
|
Active Comparator: Arm A
All subjects on this treatment arm will receive a standard paclitaxel and carboplatin chemotherapy regimen (paclitaxel 200mg/m2 and carboplatin at AUC of 6mg/mL x min by Calvert formula) on day 1 of each 3 week cycle + - 3 days for a maximum of 6 cycles and AMG 706 125mg QD orally.
|
Drug: AMG 706
125 mg QD orally every day
|
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
More Information
| Responsible Party: | Global Development Leader, Amgen Inc. |
| ClinicalTrials.gov Identifier: | NCT00460317 History of Changes |
| Other Study ID Numbers: | 20050201 |
| Study First Received: | April 12, 2007 |
| Last Updated: | September 1, 2011 |
| Health Authority: | South Korea: Korea Food & Drug Administration Spain: Spanish Drug Agency Taiwan: Taiwan Provincial Department of Health Turkey: Ministry of Health Ukraine: Ministry of Health United Kingdom: Medicines and Healthcare Products Regulatory Agency United States: Food and Drug Administration Austria: Secretariat of Health Brazil: Ministry of Health Canada: Health Canada Chile: Health Ministry Czech Republic: State Institute for Drug Control Denmark: Danish Medicines Agency France: Ministry of Health Germany: Federal Institute for Drugs and Medical Devices Greece: National Organization for Medicines Hong Kong: Department of Health Argentina: Ministry of Health Australia: Therapeutic Goods Administration Hungary: National Institute of Pharmacy India: Central Drugs Standard Control Organization Ireland: Irish Medicines Board Israel: Ministry of Health Italy: Ministry of Health Lithuania: State Medicines Control Agency of Lithuania Mexico: Ministry of Health Netherlands: Medicines Evaluation Board Phillippines: the Bureau of Food and Drugs Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Russia: Ministry of Health Singapore: Health Science Authority Slovakia: Ministry of Health |
|
lung cancer chemotherapy paclitaxel carboplatin |
placebo angiogenesis VEGF multi kinase inhibitor |
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |
Carboplatin Paclitaxel Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic |