Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Abraxis BioScience Inc. |
---|---|
Information provided by: | Abraxis BioScience Inc. |
ClinicalTrials.gov Identifier: | NCT00540514 |
The purpose of this study is to compare disease response of ABI-007 plus Carboplatin vs Taxol and Carboplatin as first-line therapy in patients with advanced NSCLC
Condition | Intervention | Phase |
---|---|---|
Non-Small Cell Lung Carcinoma |
Drug: ABI-007 Drug: Taxol |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Phase III Trial of ABI-007 and Carboplatin Compared With Taxol and Carboplatin as First-Line Therapy in Patients With Advacned Non-Small Cell Lung Cancer (NSCLC) |
Estimated Enrollment: | 1050 |
Study Start Date: | November 2007 |
Estimated Study Completion Date: | November 2009 |
Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
ABI-007 weekly
|
Drug: ABI-007
ABI-007 100mg/m2 weekly
|
2: Active Comparator
Taxol every 3 weeks
|
Drug: Taxol
Taxol 200mg/m2 q 3 weeks
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Selena Rush | 919-433-8465 | srush@abraxisbio.com |
Responsible Party: | Abraxis BioScience ( Dr. Jose Iglesias ) |
Study ID Numbers: | CA031 |
Study First Received: | October 4, 2007 |
Last Updated: | July 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00540514 |
Health Authority: | United States: Food and Drug Administration |
Advanced Non-Small Cell Lung Cancer |
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 |