A Study of Linifanib (ABT-869) in Combination With Carboplatin/Paclitaxel in Japanese Subjects With Non-Small Cell Lung Cancer (NSCLC)
NCT ID: NCT01225302
Last Updated: 2017-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
12 participants
INTERVENTIONAL
2010-09-30
2012-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm A
Linifanib
Low dose linifanib (once a day)
Carboplatin
Given on Day 1 of every 21-day cycle
Paclitaxel
Given on Day 1 of every 21-day cycle
Arm B
Linifanib
High dose linifanib (once a day)
Carboplatin
Given on Day 1 of every 21-day cycle
Paclitaxel
Given on Day 1 of every 21-day cycle
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Linifanib
Low dose linifanib (once a day)
Linifanib
High dose linifanib (once a day)
Carboplatin
Given on Day 1 of every 21-day cycle
Paclitaxel
Given on Day 1 of every 21-day cycle
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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.
20 Years
99 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AbbVie
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Susumu Matsuki, BS
Role: STUDY_DIRECTOR
Abbott Japan Co.,Ltd
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Horinouchi H, Yamamoto N, Nokihara H, Horai T, Nishio M, Ohyanagi F, Horiike A, Nakagawa K, Terashima M, Okabe T, Kaneda H, McKee MD, Carlson DM, Xiong H, Tamura T. A phase 1 study of linifanib in combination with carboplatin/paclitaxel as first-line treatment of Japanese patients with advanced or metastatic non-small cell lung cancer (NSCLC). Cancer Chemother Pharmacol. 2014 Jul;74(1):37-43. doi: 10.1007/s00280-014-2478-9. Epub 2014 May 8.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
W12-076
Identifier Type: -
Identifier Source: org_study_id