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Sponsors and Collaborators: |
Abbott Genentech |
---|---|
Information provided by: | Abbott |
ClinicalTrials.gov Identifier: | NCT00716534 |
This study is designed to determine the clinical efficacy and toxicity of ABT-869 in combination with carboplatin and paclitaxel in the treatment of subjects with advanced or metastatic NSCLC.
Condition | Intervention | Phase |
---|---|---|
Advanced or Metastatic Non-Small Cell Lung Cancer |
Drug: ABT-869 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Single Group Assignment |
Official Title: | A Phase 2 Randomized, Placebo-Controlled, Double-Blind Study of Carboplatin/Paclitaxel in Combination With ABT-869 Versus Carboplatin/Paclitaxel Alone in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) as First-Line Treatment |
Estimated Enrollment: | 80 |
Study Start Date: | June 2008 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
0.20 mg/kg: Experimental |
Drug: ABT-869
0.20 mg/kg
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Brian L. Oliver, BS | 847-938-5570 | brian.oliver@abbott.com |
United States, Georgia | |
Emory University | Recruiting |
Atlanta, Georgia, United States, 30322 | |
Contact 404-727-6123 | |
Principal Investigator: Suresh Ramalingam, MD | |
United States, Pennsylvania | |
Pennsylvania Oncology Hematology Associates | Not yet recruiting |
Philadelphia, Pennsylvania, United States, 19106 | |
Contact 800-789-7366 | |
Principal Investigator: David Henry, MD |
Responsible Party: | Abbott ( Joyce Steinberg MD/Global Medical Director ) |
Study ID Numbers: | M10-301 |
Study First Received: | July 14, 2008 |
Last Updated: | September 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00716534 |
Health Authority: | United States: Food and Drug Administration |
Thoracic Neoplasms Non-small cell lung cancer Respiratory Tract Diseases Paclitaxel Lung Neoplasms |
Lung Diseases Carboplatin Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Mitosis Modulators Tubulin Modulators Antimitotic Agents Antineoplastic Agents, Phytogenic Pharmacologic Actions |