Safety and Effectiveness of ABT-510 Plus Combination Chemotherapy in Subjects With Non-Small Cell Lung Cancer (NSCLC)
This study has been terminated.
(Enrollment suspended based upon interim analysis; subjects allowed to stay on study until disease progression.)
Information provided by:
First received: June 2, 2003
Last updated: August 10, 2007
Last verified: August 2007
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.
Carcinoma, Non-Small-Cell Lung
Drug: ABT-510/Thrombospondin-1 mimetic
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||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)
Primary Outcome Measures:
- Progression free survival [ Time Frame: One year ]
Secondary Outcome Measures:
- Overall survival [ Time Frame: One year ]
- Response rate [ Time Frame: One year ]
| Study Start Date:
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- The subject has a history of or currently exhibits Central Nervous System (CNS) metastasis. Brain MRI within 28 days of enrollment is required to confirm absence of CNS metastases.
- The subject is receiving therapeutic anticoagulation therapy. Low dose anticoagulation for catheter prophylaxis will be permitted; PT/PTT must be within normal limits.
- The subject has a history of or currently exhibits clinically significant cancer related events of bleeding (e.g., hemoptysis). The subject has a recent history of (within 4 weeks from Study Day 1) or currently exhibits other clinically significant events of bleeding.
- The subject has received investigational therapy within four weeks prior to study drug administration.
- The subject exhibits evidence of clinically significant uncontrolled condition(s) and/or is considered by the investigator to be unable to tolerate the proposed treatment or procedures.
- The subject has previous or current malignancies at other sites, with the exception of: Adequately treated in situ carcinoma of the cervix uteri; Basal or squamous cell carcinoma of the skin; Previous nonpulmonary malignancy confined and surgically resected with no evidence of active malignancy.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00061646
|Oncology-Hematology Group of South Florida
|Miami, Florida, United States, 33176 |
|University of Chicago
|Chicago, Illinois, United States, 60637-1470 |
|The West Cancer Clinic
|Memphis, Tennessee, United States, 38120 |
|University of Wisconsin
|Madison,, Wisconsin, United States, 53792-5666 |
||Global Medical Information 1-800-633-9110
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 2, 2003
||August 10, 2007
||United States: Food and Drug Administration
Keywords provided by Abbott:
Stage IIIb with pleural effusion or IV NSCLC
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 09, 2014
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Respiratory Tract Neoplasms
Neoplasms by Site
Respiratory Tract Diseases