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Sponsored by: |
Amgen |
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Information provided by: | Amgen |
ClinicalTrials.gov Identifier: | NCT00791154 |
This trial is titled "A Phase 1b/2 trial of AMG 479 or AMG 102 with Platinum-Based Chemotherapy as First-Line Treatment for Extensive Stage Small-Cell Lung Cancer (SCLC)."
Part 1, the phase 1b portion of this study, is a multicenter, open-label investigation to identify safe dose levels of either AMG 102 or AMG 479 in combination with etoposide plus cisplatin or carboplatin in subjects with previously untreated extensive stage SCLC.
Part 2, the phase 2 portion of this study, is a multicenter, double-blind, 3-arm investigation to evaluate overall survival of either AMG 102 or AMG 479 in combination with platinum-based chemotherapy.
Condition | Intervention | Phase |
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Lung Cancer Small Cell Lung Cancer Solid Tumors Extensive-Stage Small Cell Lung Cancer |
Drug: AMG 102 in combination with Cisplatin/Etopiside Drug: AMG 479 in combination with Carboplatin/Etopiside Drug: AMG 102 in combination with Carboplatin/Etopiside Drug: AMG 479 in combination with Cisplatin/Etopiside |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Parallel Assignment, Safety Study |
Official Title: | Amgen Protocol 20060534 - A Phase 1b/2 Trial of AMG 479 or AMG 102 in Combination With Platinum-Based Chemotherapy as First-Line Treatment for Extensive Stage Small Cell Lung Cancer |
Estimated Enrollment: | 204 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | April 2014 |
Estimated Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Cohort 2a: Active Comparator
Investigational Product : Active Comparator
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Drug: AMG 479 in combination with Cisplatin/Etopiside
AMG 479 is administered to subjects in combination with Cisplatin and Etopiside
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Cohort 1a: Active Comparator
Investigational Product : Active Comparator
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Drug: AMG 479 in combination with Carboplatin/Etopiside
AMG 479 is administered to subjects in combination with Carboplatin and Etopiside
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Cohort 3a: Active Comparator
Investigational Product : Active Comparator
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Drug: AMG 102 in combination with Carboplatin/Etopiside
AMG 102 is administered to subjects in combination with Carboplatin and Etopiside
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Cohort 4a: Active Comparator
Investigational Product : Active Comparator
|
Drug: AMG 102 in combination with Cisplatin/Etopiside
AMG 102 is administered to subjects in combination with Cisplatin and Etopiside
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Key Inclusion Criteria
Key Exclusion Criteria
Contact: Amgen Call Center | 866-572-6436 |
United States, Kentucky | |
Research Site | Recruiting |
Paducah, Kentucky, United States | |
United States, South Carolina | |
Research Site | Recruiting |
Greenville, South Carolina, United States | |
United States, Tennessee | |
Research Site | Recruiting |
Memphis, Tennessee, United States | |
Belgium | |
Research Site | Recruiting |
Charleroi, Belgium | |
France | |
Research Site | Recruiting |
Caen, France | |
Spain | |
Research Site | Recruiting |
Barcelona, Spain |
Study Director: | MD | Amgen |
Responsible Party: | Amgen Inc. ( Global Development Leader ) |
Study ID Numbers: | 20060534 |
Study First Received: | October 23, 2008 |
Last Updated: | January 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00791154 |
Health Authority: | 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.; Spain: reference Ethics Committee; Sweden: Ethics Committee in Stockholm; Sweden: Etikprovningsnamnden i Stockholm; Sweden: Lakemedelsverket; Sweden: Medical Products Agency; Australia: Therapeutic Goods Administration; Belgium: Federal Agency for Medicines and Health Products (FAMHP); United Kingdom: Medicines and Healthcare Products Regulatory Agency; United States: Food and Drug Administration; United States: Western Institutional Review Board; France: Afssaps - French Health Products Safety Agency; France: Central EC, called Comite de Protection des Personnes; Italy: Local Ethics Committees |
Extensive disease Extrathoracic metasasis Malignant pericardial effusion Malignant pleural effusion Contralateral hilar adenopathy |
Thoracic Neoplasms Carcinoma, Neuroendocrine Pleural Effusion, Malignant Pericardial Effusion Carboplatin Carcinoma Neuroendocrine Tumors Carcinoma, Small Cell Pleural Effusion Lymphatic Diseases |
Neuroectodermal Tumors Cisplatin Respiratory Tract Diseases Lung Neoplasms Neoplasms, Germ Cell and Embryonal Lung Diseases Neuroepithelioma Adenocarcinoma Neoplasms, Glandular and Epithelial |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Radiation-Sensitizing Agents |
Antineoplastic Agents Therapeutic Uses Physiological Effects of Drugs Neoplasms, Nerve Tissue Pharmacologic Actions |