Back to resultsA Study of Linifanib (ABT-869) in Combination With Carboplatin/Paclitaxel in Japanese Subjects With Non-Small Cell Lung Cancer (NSCLC)
Primary Purpose
Non-Small Cell Lung Cancer
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Linifanib
Linifanib
Carboplatin
Paclitaxel
Sponsored by
About this trial
This is an interventional treatment trial for Non-Small Cell Lung Cancer
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Arm A
Arm B
Arm Description
Outcomes
Primary Outcome Measures
Safety (Number of patients with adverse events and/or dose-limiting toxicities)
Evaluation of vital signs, physical exams, clinical lab testing and adverse event monitoring.
Secondary Outcome Measures
Preliminary tumor response
Computed Tomography (CT) scan
Preliminary tumor response
Computed Tomography (CT) scan
Preliminary tumor response
Computed Tomography (CT) scan
Preliminary tumor response
Computed Tomography (CT) scan
Preliminary tumor response
Computed Tomography (CT) scan
Preliminary tumor response
Computed Tomography (CT) scan
Preliminary tumor response
Computed Tomography (CT) scan
Preliminary tumor response
Computed Tomography (CT) scan
Preliminary tumor response
Computed Tomography (CT) scan
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01225302
Brief Title
A Study of Linifanib (ABT-869) in Combination With Carboplatin/Paclitaxel in Japanese Subjects With Non-Small Cell Lung Cancer (NSCLC)
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm A
Arm Type
Experimental
Arm Title
Arm B
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Linifanib
Other Intervention Name(s)
ABT-869
Intervention Description
Low dose linifanib (once a day)
Intervention Type
Drug
Intervention Name(s)
Linifanib
Other Intervention Name(s)
ABT-869
Intervention Description
High dose linifanib (once a day)
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Other Intervention Name(s)
Paraplatin
Intervention Description
Given on Day 1 of every 21-day cycle
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
Taxol
Intervention Description
Given on Day 1 of every 21-day cycle
Primary Outcome Measure Information:
Title
Safety (Number of patients with adverse events and/or dose-limiting toxicities)
Description
Evaluation of vital signs, physical exams, clinical lab testing and adverse event monitoring.
Time Frame
At each treatment visit (weekly for 6 weeks, then every 3 weeks)
Secondary Outcome Measure Information:
Title
Preliminary tumor response
Description
Computed Tomography (CT) scan
Time Frame
Week 6
Title
Preliminary tumor response
Description
Computed Tomography (CT) scan
Time Frame
Week 12
Title
Preliminary tumor response
Description
Computed Tomography (CT) scan
Time Frame
Week 18
Title
Preliminary tumor response
Description
Computed Tomography (CT) scan
Time Frame
Week 24
Title
Preliminary tumor response
Description
Computed Tomography (CT) scan
Time Frame
Week 30
Title
Preliminary tumor response
Description
Computed Tomography (CT) scan
Time Frame
Week 36
Title
Preliminary tumor response
Description
Computed Tomography (CT) scan
Time Frame
Week 42
Title
Preliminary tumor response
Description
Computed Tomography (CT) scan
Time Frame
Week 48
Title
Preliminary tumor response
Description
Computed Tomography (CT) scan
Time Frame
Week 54
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susumu Matsuki, BS
Organizational Affiliation
Abbott Japan Co.,Ltd
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
24807459
Citation
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.
Results Reference
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A Study of Linifanib (ABT-869) in Combination With Carboplatin/Paclitaxel in Japanese Subjects With Non-Small Cell Lung Cancer (NSCLC)
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