A Study of Linifanib (ABT-869) in Combination With Carboplatin/Paclitaxel in Japanese Subjects With Non-Small Cell Lung Cancer (NSCLC)

Non-Small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01225302
• Other study ID #: W12-076
• Status: Completed
• Phase: Phase 1
• First received: September 28, 2010
• Last updated: November 17, 2017
• Start date: September 2010
• Est. completion date: June 2012

Study information

• Verified date: July 2012
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

Drug:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

References & Publications (1)

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 trea — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At each treatment visit (weekly for 6 weeks, then every 3 weeks)
Secondary	Preliminary tumor response	Computed Tomography (CT) scan	Week 6
Secondary	Preliminary tumor response	Computed Tomography (CT) scan	Week 12
Secondary	Preliminary tumor response	Computed Tomography (CT) scan	Week 18
Secondary	Preliminary tumor response	Computed Tomography (CT) scan	Week 24
Secondary	Preliminary tumor response	Computed Tomography (CT) scan	Week 30
Secondary	Preliminary tumor response	Computed Tomography (CT) scan	Week 36
Secondary	Preliminary tumor response	Computed Tomography (CT) scan	Week 42
Secondary	Preliminary tumor response	Computed Tomography (CT) scan	Week 48
Secondary	Preliminary tumor response	Computed Tomography (CT) scan	Week 54