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| Sponsor: | Amgen |
|---|---|
| Information provided by: | Amgen |
| ClinicalTrials.gov Identifier: | NCT00858364 |
Purpose
This is a double-blind, randomized, placebo-controlled phase 3 non-inferiority study in subjects with chemotherapy induced anemia receiving multi-cycle chemotherapy for the treatment of metastatic (stage IV) Non-Small Cell Lung Cancer (NSCLC). Approximately 3000 subjects with metastatic (stage IV) NSCLC expecting to receive at least 2 additional cycles (at least 6 total weeks) of first line myelosuppressive cyclic chemotherapy will be enrolled into the study. Subjects will be randomized in a 2:1 allocation (Group A: darbepoetin alfa 500 µg every 3 weeks <Q3W>, Group B: placebo Q3W)
| Condition | Intervention | Phase |
|---|---|---|
|
Non-Small Cell Lung Cancer Anemia Cancer Lung Cancer |
Drug: darbepoetin alfa 500 mcg Q3W Drug: placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Supportive Care |
| Official Title: | A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Long-term Safety and Efficacy of Darbepoetin Alfa Administered at 500 µg Once-Every-3-Weeks in Anemic Subjects With Advanced Stage Non-small Cell Lung Cancer Receiving Multi-cycle Chemotherapy |
| Estimated Enrollment: | 3000 |
| Study Start Date: | June 2009 |
| Estimated Study Completion Date: | June 2019 |
| Estimated Primary Completion Date: | February 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: A
darbepoetin alfa 500 µg (Q3W)
|
Drug: darbepoetin alfa 500 mcg Q3W
darbepoetin alfa 500 mcg (Q3W)
|
|
Placebo Comparator: B
Placebo Q3W
|
Drug: placebo
Placebo
|
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| Contact: Amgen Call Center | 866-572-6436 |
Show 449 Study Locations| Study Director: | MD | Amgen |
More Information
| Responsible Party: | Global Development Leader, Amgen Inc. |
| ClinicalTrials.gov Identifier: | NCT00858364 History of Changes |
| Other Study ID Numbers: | 20070782 |
| Study First Received: | March 5, 2009 |
| Last Updated: | January 18, 2012 |
| Health Authority: | Greece: Ministry of Health & Social Solidarity, National Organization for Medicines; Greece: National Ethics Committee; Argentina: Ministry of Health; Austria: Central Ethics Committee; Greece: National Organization for Medicines; Hong Kong: Department of Health; India: Central Drugs Standard Control Organization; Ireland: Irish Medicines Board; Israel: Ministry of Health; Italy: Local Ethics Committees; Italy: Ministry of Health; Italy: The Istituto Superiore di Sanità (ISS) within the Italian National Health Service. Its activities include research, control, training and consultation in the interest of public health protection. Responsible to approved the phase 1 studies.; Luxembourg: Comité National d'Ethique de Recherche; Luxembourg: Direction de la Santé, Division de la Pharmacie et des Médicaments; Mexico: COFEPRIS; Mexico: Ministry of Health; Mexico: SSA (Secretaria de Salud Publica); Netherlands: CCMO (Centrale Commissie Mensgebonden Onderzoek): Central Committee Human Bound Research; Netherlands: Medicines Evaluation Board; Netherlands: Medisch Centrum Rijnmond_Zuid, lcatie Zuider; Phillippines: the Bureau of Food and Drugs; Poland: Drug Institut; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Romaina: National Medicines Agency; Romania: Ministry of Health and the Family; Romania: Romanian National Drug Agency; Russia: Federal Service for Surveillance in the field of Healthcare and Social Development (a body of the Ministry of Health); Russia: Ministry of Health; Serbia: Medicine and Medical Devices Agency of Serbia; Slovenia: Agency for Medicinal Products and Medicinal Devices of the Republic of Slovenia (ARSZMP); Slovenia: National Medical Ethics Committee (Komisija Republike Slovenije Za Medicinsko Etiko); South Africa: Department of Health; Spain: reference Ethics Committee; Spain: Spanish Agency of Medicines; Spain: Spanish Drug Agency; Switzerland: Agency for Therapeutic Products; Switzerland: Local Ethics Committee; Taiwan: Department of Health; Taiwan: Taiwan Food and Drug Administration; Taiwan: Taiwan Provincial Department of Health; Ukraine: Ministry of Health; Ukraine: Pharmacological Centre at the Ministry of Health of the Ukraine (Pharma Centre); United Kingdom: Medicines and Healthcare Products Regulatory Agency; United States: Food and Drug Administration; United States: Institutional Review Board; Austria: Federal Ministry for Health and Women; Austria: Secretariat of Health; Belgium: Directorate general for the protection of Public health: Medicines; Belgium: Federal Public Service (FPS) Health, Food Chain Safety and Environment; Belgium: Pharmaceutical Inspectorate; Brazil: Ministry of Health; Bulgaria: Bulgarian Drug Agency; Bulgaria: Ministry of Health; Canada: Health Canada; Canada: Institutional Review Board; Chile: Health Ministry; Croatia: Central Ethics Committee Sredisnje Eticko Povjerenstvo; Croatia: Ministarstvo zdravstva i socijalne skrbi (Ministry of Health and Social Welfare); Czech Republic: State Institute for Drug Control; EU: CHMP; Germany: Federal Institute for Drugs and Medical Devices |
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darbepoetin alfa non-small cell lung cancer Aranesp chemotherapy chemotherapy induce anemia advanced lung cancer malignant pleural effusion |
metastatic lung cancer NSCLC anemia lung cancer pleural effusion Stage IIIB lung cancer Stage IV lung cancer |
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Anemia Carcinoma, Non-Small-Cell Lung Lung Neoplasms Hematologic Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases Darbepoetin alfa Hematinics Hematologic Agents Therapeutic Uses Pharmacologic Actions |