A Phase 1 Study of Linifanib (ABT-869) in Combination With Carboplatin/Paclitaxel in Japanese Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) as First-Line Treatment
- The subject must be 20 and older years of age.
- The subject must have cytologically or histologically confirmed non-squamous NSCLC.
Subjects may have a mixed histology but must be predominantly non-squamous to be
- The subject must have advanced or metastatic (Stage IV [According to American Joint
Committee on Cancer (AJCC) staging manual, 7th edition]) disease that is not amenable
to surgical resection or radiation with curative intent.
- The subject must have not received prior chemotherapy for NSCLC.
- The subject has measurable disease, defined as at least 1 unidimensionally measurable
lesion on a CT scan as defined by Response Evaluation Criteria in Solid Tumors
(RECIST) Version 1.1.
- The subject has an Easter Cooperative Oncology Group (ECOG) Performance Score of 0-1.
- The subject must have adequate bone marrow, renal and hepatic function.
- The subject has hypersensitivity to paclitaxel or to other drugs formulated with
polyethoxylated castor oil (Cremophor).
- The subject has received any anti-cancer therapy for treatment of NSCLC including
investigational agents, immunotherapy, traditional Chinese medicine/herbal remedies,
hormonal, "targeted" agents (i.e., erlotinib, imatinib), biologic therapy or
cytotoxic chemotherapy (i.e., alkylating agents, microtubule inhibitors,
- The subject has a history of another active cancer within the past 5 years except
cervical cancer in situ, in situ carcinoma of the bladder, squamous cell or basal
cell carcinoma of the skin.
- The subject has active ulcerative colitis, Crohn's disease, celiac disease or any
other conditions that interfere with absorption.
- The subject has a medical condition, which in the opinion of the study investigator
places them at an unacceptably high risk for toxicities.
- The subject is pregnant or breast feeding.
- The subject has NSCLC with a predominant squamous cell histology.