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)
- 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
- The subject is able to self-administer or has a caregiver who can reliably administer
- 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
- 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
- The subject is receiving therapeutic anticoagulation therapy. Low dose
anticoagulation for catheter prophylaxis will be permitted; PT/PTT must be within
- 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
- 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.