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| Sponsor: | Abbott |
|---|---|
| Information provided by: | Abbott |
| ClinicalTrials.gov Identifier: | NCT00061646 |
Purpose
The primary objective of this Phase II study is to assess the safety, pharmacokinetics and effectiveness of ABT-510 in combination with standard carboplatin/paclitaxel chemotherapy in subjects with stage IIIb or IV NSCLC.
| Condition | Intervention | Phase |
|---|---|---|
|
Carcinoma, Non-Small-Cell Lung |
Drug: ABT-510/Thrombospondin-1 mimetic Drug: Carboplatin/Taxol |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | A Phase II Single-Arm Study Evaluating the Safety and Effectiveness of ABT-510 Plus Combination Chemotherapy in Subjects With Non-Small Cell Lung Cancer (NSCLC) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
The subject must have adequate bone marrow, renal and hepatic function as follows:
Exclusion Criteria
Contacts and Locations| United States, Florida | |
| Oncology-Hematology Group of South Florida | |
| Miami, Florida, United States, 33176 | |
| United States, Illinois | |
| University of Chicago | |
| Chicago, Illinois, United States, 60637-1470 | |
| United States, Tennessee | |
| The West Cancer Clinic | |
| Memphis, Tennessee, United States, 38120 | |
| United States, Wisconsin | |
| University of Wisconsin | |
| Madison,, Wisconsin, United States, 53792-5666 | |
| Study Director: | Global Medical Information 1-800-633-9110 | Abbott |
More Information
| Study ID Numbers: | M02-429 |
| Study First Received: | June 2, 2003 |
| Last Updated: | August 10, 2007 |
| ClinicalTrials.gov Identifier: | NCT00061646 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Stage IIIb with pleural effusion or IV NSCLC |
|
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms by Histologic Type Antineoplastic Agents Carboplatin Pharmacologic Actions Carcinoma Neoplasms |
Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |