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Sponsored by: |
Novartis Pharmaceuticals |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00219297 |
The study objective is to evaluate the safety and efficacy of patupilone with respect to early progression and response of patients with non-small cell lung cancer (NSCLC) metastatic to the brain, who have progressed after chemotherapy, surgery and/or radiation.
Condition | Intervention | Phase |
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Brain Metastasis Non-Small Cell Lung Cancer |
Drug: Patupilone |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Open-Label, Multi-Center, Phase II Study to Evaluate the Activity of Patupilone (EPO906), in the Treatment of Recurrent or Progressive Brain Metastases in Patients With Non-Small Cell Lung Cancer. |
Estimated Enrollment: | 50 |
Study Start Date: | November 2005 |
Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Novartis Pharmaceuticals | +1-800-340-6843 |
United States, District of Columbia | |
Georgetown University/Lombardi Cancer Center | Recruiting |
Washington, District of Columbia, United States, 20007 | |
Contact: Patricia Dunn 202-687-1569 pcd7@georgetown.edu | |
Principal Investigator: Shakun Malick, M.D. | |
United States, Massachusetts | |
Dana Farber Cancer Institute | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Contact: Jennifer Zimmerman 617-632-6684 jennifer_zimmerman@dfci.harvard.edu | |
Principal Investigator: Patrick Wen, Dr. | |
United States, Missouri | |
St. Louis University Cancer Center | Recruiting |
St. Louis, Missouri, United States, 63110 | |
Contact: Lynne Klipsch 314-268-7059 klipschm@slu.edu | |
Principal Investigator: Hans Joachim Reimers, Dr. | |
Dartmouth-Hitchcock Medical Center | Recruiting |
St. Louis, Missouri, United States, 03756 | |
Contact: Ian Williams, Mr. 603-650-7966 ian.r.williams@dartmouth.edu | |
Principal Investigator: James Rigas, Dr. | |
Washington University School of Medicine | Recruiting |
St. Louis, Missouri, United States, 63110 | |
Contact: Kristina Williams 314-362-6963 | |
Principal Investigator: Ramaswamy Govindan, Dr. | |
United States, New York | |
Memorial Sloan-Kettering Cancer Center | Recruiting |
New York, New York, United States, 10021 | |
Contact: Chandra Casas 646-227-2267 casasc@mskcc.org | |
Principal Investigator: Laura Abrey, Dr. | |
United States, Washington | |
Swedish Cancer Institute | Recruiting |
Seattle, Washington, United States, 98104 | |
Contact: Dione Pedersen 206-386-2444 dione.pedersen@swedish.org | |
Principal Investigator: Howard J West, Dr. | |
Swedish Cancer Institute | Recruiting |
Seattle, Washington, United States, 98119 | |
Contact: Dione Pedersen 206-386-2444 dione.pedersen@swedish.org | |
Principal Investigator: Howard J West, Dr. | |
United States, Wisconsin | |
U. of Wisconsin Hospitals and Clinics | Recruiting |
Madison, Wisconsin, United States, 53792 | |
Contact: Diana Trask 608-263-9528 trask@humonc.wisc.edu | |
Principal Investigator: H. Ian Robins, M.D. |
Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Responsible Party: | Novartis Pharmaceuticals ( External Affairs ) |
Study ID Numbers: | CEPO906A2227 |
Study First Received: | September 21, 2005 |
Last Updated: | November 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00219297 |
Health Authority: | United States: Food and Drug Administration |
EPO EPO906 Brain cancer Brain metastasis |
Lung cancer Lung metastasis Brain metastasis from non-small cell lung cancer |
Thoracic Neoplasms Epothilone B Non-small cell lung cancer Epothilones Central Nervous System Diseases Central Nervous System Neoplasms Brain Diseases Recurrence Carcinoma |
Brain Neoplasms Respiratory Tract Diseases Lung Neoplasms Lung Diseases Neoplasm Metastasis Carcinoma, Non-Small-Cell Lung Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
Respiratory Tract Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Nervous System Diseases Mitosis Modulators Antimitotic Agents |
Pharmacologic Actions Neoplasms Neoplastic Processes Neoplasms by Site Pathologic Processes Therapeutic Uses Tubulin Modulators |