Status:
COMPLETED
A Study of Linifanib (ABT-869) in Combination With Carboplatin/Paclitaxel in Japanese Subjects With Non-Small Cell Lung Cancer (NSCLC)
Lead Sponsor:
AbbVie
Conditions:
Non-Small Cell Lung Cancer
Eligibility:
All Genders
20-99 years
Phase:
PHASE1
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 Japa...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01225302
Start Date
September 1 2010
End Date
June 1 2012
Last Update
November 21 2017
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