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

NCT01225302 | Completed Phase 1 DMC

• 1 other identifier: W12-076
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Preliminary tumor response

  Week 6

• Preliminary tumor response

  Week 12

• Preliminary tumor response

  Week 18

• Preliminary tumor response

  Week 24

• Preliminary tumor response

  Week 30

Study Arms (2)

Arm A

EXPERIMENTAL

Drug: Linifanib; Drug: Carboplatin; Drug: Paclitaxel

Arm B

EXPERIMENTAL

Drug: Linifanib; Drug: Carboplatin; Drug: Paclitaxel

Interventions

Linifanib DRUG

Low dose linifanib (once a day)

Also known as: ABT-869

Arm A

Carboplatin DRUG

Given on Day 1 of every 21-day cycle

Also known as: Paraplatin

Arm A; Arm B

Paclitaxel DRUG

Given on Day 1 of every 21-day cycle

Also known as: Taxol

Arm A; Arm B

Eligibility Criteria

• Age: 20 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Related 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 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.

  PMID: 24807459 RESULT

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

linifanib; Carboplatin; Paclitaxel

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Susumu Matsuki, BS

  Abbott Japan Co.,Ltd

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2010
• First Posted: October 21, 2010
• Study Start: September 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: November 21, 2017

Record last verified: 2012-07