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Sponsored by: |
Cell Therapeutics |
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Information provided by: | Cell Therapeutics |
ClinicalTrials.gov Identifier: | NCT00269828 |
This is a randomized, open-label, multinational, phase III study in women with histologically- or cytologically-confirmed advanced NSCLC who are chemotherapy naïve and have PS 2. Study drug will be administered on day 1 of each 21 day cycle
Condition | Intervention | Phase |
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NSCLC |
Drug: paclitaxel Drug: paclitaxel poliglumex |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Paclitaxel Poliglumex (CT-2103) vs. Paclitaxel for the Treatment of Women With Chemotherapy-Naïve Advanced Non-Small Cell Lung Cancer (NSCLC) Who Are Performance Status 2. |
Estimated Enrollment: | 600 |
Study Start Date: | December 2005 |
Estimated Study Completion Date: | December 2006 |
See Summary
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients who meet one of the following criteria:
Exclusion Criteria:
Study ID Numbers: | PGT305, PIONEER |
Study First Received: | December 22, 2005 |
Last Updated: | February 13, 2007 |
ClinicalTrials.gov Identifier: | NCT00269828 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Non-small cell lung cancer NSCLC PS 2 female chemotherapy |
Thoracic Neoplasms Respiratory Tract Diseases Paclitaxel Lung Neoplasms Lung Diseases Tubulin Modulators |
Non-small Cell Lung Cancer Antimitotic Agents Antineoplastic Agents, Phytogenic Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Antimitotic Agents 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 |