Clinical trial NCT01225302: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Non-Small Cell Lung Cancer
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2010-10-21
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Safety (Number of patients with adverse events and/or dose-limiting toxicities)
timeFrame: At each treatment visit (weekly for 6 weeks, then every 3 weeks)
Secondary outcomes:
measure: Preliminary tumor response
timeFrame: Week 6
measure: Preliminary tumor response
timeFrame: Week 12
measure: Preliminary tumor response
timeFrame: Week 18
measure: Preliminary tumor response
timeFrame: Week 24
measure: Preliminary tumor response
timeFrame: Week 30
measure: Preliminary tumor response
timeFrame: Week 36
measure: Preliminary tumor response
timeFrame: Week 42
measure: Preliminary tumor response
timeFrame: Week 48
measure: Preliminary tumor response
timeFrame: Week 54
Other outcomes:
Locations:
Study officials:
affiliation: Abbott Japan Co.,Ltd
name: Susumu Matsuki, BS
role: STUDY_DIRECTOR
References:
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.