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Sponsors and Collaborators: |
Abbott Genentech |
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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 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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0.20 mg/kg: Experimental |
Drug: ABT-869
0.20 mg/kg
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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, Arizona | |
Ironwood Cancer and Research Centers | Not yet recruiting |
Chandler, Arizona, United States, 85224 | |
Contact 480-821-2838 | |
Principal Investigator: Mikhail Shtivelband, MD, PhD | |
Pivotal Research Centers | Not yet recruiting |
Peoria, Arizona, United States, 85381 | |
Contact 623-977-1234 | |
Principal Investigator: Divis Khaira, MD | |
United States, Georgia | |
Emory University | Recruiting |
Atlanta, Georgia, United States, 30322 | |
Contact 404-727-6123 | |
Principal Investigator: Suresh Ramalingam, MD | |
United States, Illinois | |
Ingalls Memorial Hospital | Recruiting |
Harvey, Illinois, United States, 60426 | |
Contact 708-915-6620 | |
Principal Investigator: James Wallace, MD | |
United States, Michigan | |
Sparrow Regional Cancer Center | Not yet recruiting |
Lansing, Michigan, United States, 48912 | |
Contact 517-364-1000 | |
Principal Investigator: Gordon Srkalovic, MD, PhD | |
United States, New Hampshire | |
Dartmouth Hitchcock Medical Center | Not yet recruiting |
Lebanon, New Hampshire, United States, 03756 | |
Contact 800-639-6918 | |
Principal Investigator: Konstantin Dragnev, MD | |
United States, North Carolina | |
Moses Cone Regional Cancer Center | Not yet recruiting |
Greensboro, North Carolina, United States, 27403 | |
Contact 336-832-0821 | |
Principal Investigator: Mohamed Mohamed, MD | |
United States, Pennsylvania | |
Pennsylvania Oncology Hematology Associates | Recruiting |
Philadelphia, Pennsylvania, United States, 19106 | |
Contact 800-789-7366 | |
Principal Investigator: David Henry, MD | |
Pottstown Memorial Regional Cancer Center | Not yet recruiting |
Pottstown, Pennsylvania, United States, 19464 | |
Contact 610-327-7544 | |
Principal Investigator: Wei Song, MD | |
United States, Texas | |
University of Texas Southwestern Medical Center | Not yet recruiting |
Dallas, Texas, United States, 75390 | |
Contact 214-648-6449 | |
Principal Investigator: Jonathan Dowell, MD |
Responsible Party: | Abbott ( Justin Ricker MD, PhD/Global Medical Director ) |
Study ID Numbers: | M10-301 |
Study First Received: | July 14, 2008 |
Last Updated: | April 10, 2009 |
ClinicalTrials.gov Identifier: | NCT00716534 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Thoracic Neoplasms Carboplatin Antimitotic Agents Carcinoma Respiratory Tract Diseases Lung Neoplasms Paclitaxel |
Lung Diseases Tubulin Modulators Non-small Cell Lung Cancer Carcinoma, Non-Small-Cell Lung Antineoplastic Agents, Phytogenic Neoplasms, Glandular and Epithelial |
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Antimitotic Agents Carboplatin Pharmacologic Actions Carcinoma Neoplasms |
Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Paclitaxel Therapeutic Uses Lung Diseases Tubulin Modulators Antineoplastic Agents, Phytogenic Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |