Non-Small Cell Lung Cancer
Conditions
Brief summary
The primary objective of this study is to assess the safety and pharmacokinetics of linifanib, and identify tolerable dose of linifanib (ABT-869) in combination with carboplatin and paclitaxel in Japanese subjects with advanced or metastatic non-small cell lung cancer (NSCLC). Secondary objective is to obtain a preliminary efficacy of anti-tumor activity in the subjects as first-line treatment.
Interventions
DRUGLinifanib
Low dose linifanib (once a day)
DRUGCarboplatin
Given on Day 1 of every 21-day cycle
DRUGPaclitaxel
Given on Day 1 of every 21-day cycle
Sponsors
AbbVie
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* 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 eligible. * 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.
Exclusion criteria
* 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, antimetabolites). * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety (Number of patients with adverse events and/or dose-limiting toxicities) | At each treatment visit (weekly for 6 weeks, then every 3 weeks) | Evaluation of vital signs, physical exams, clinical lab testing and adverse event monitoring. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Preliminary tumor response | Week 6 | Computed Tomography (CT) scan |
Outcome results
None listed