Carcinoma, Non-Small-Cell Lung Clinical Trial
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)
NCT number | NCT00061646 |
Other study ID # | M02-429 |
Secondary ID | |
Status | Terminated |
Phase | Phase 2 |
First received | June 2, 2003 |
Last updated | August 10, 2007 |
Start date | March 2003 |
Verified date | August 2007 |
Source | Abbott |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 25 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria - The subject is at least 18 years of age. - The subject has histologically or cytology documented Stage IIIB with pleural effusion or Stage IV NSCLC. The subject must have measurable disease (RECIST Criteria for Tumor Response). - The subject has not received first line therapy for treatment of NSCLC. - The subject must not be pregnant or lactating and all subjects (male and female) must use a contraceptive method deemed acceptable by the investigator while in the study and for up to two months following completion of therapy. - The subject has an Eastern Cooperative Oncology Group (ECOG) performance score of 0-1. - The subject is able to self-administer or has a caregiver who can reliably administer SC injections. - The subject must have adequate bone marrow, renal and hepatic function as follows: - Bone marrow: White blood cell count (WBC) >= 3,000/mm3; Platelets; >= 100,000/mm3; Hemoglobin >= 9.0 g/dL; - Renal function: Serum creatinine <= 2.0 mg/dL; - Hepatic function: Bilirubin <= 1.5 mg/dL; AST and ALT <= 1.5 X the upper normal limit (ULN); unless liver metastases are present, then AST and ALT <= 5.0 x ULN. - The subject has voluntarily signed and dated an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved consent prior to any study specific procedures. Exclusion Criteria - 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. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Chicago | Chicago | Illinois |
United States | University of Wisconsin | Madison, | Wisconsin |
United States | The West Cancer Clinic | Memphis | Tennessee |
United States | Oncology-Hematology Group of South Florida | Miami | Florida |
Lead Sponsor | Collaborator |
---|---|
Abbott |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression free survival | One year | ||
Secondary | Overall survival | One year | ||
Secondary | Response rate | One year |
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