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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT01225302
First received: September 28, 2010
Last updated: July 13, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Non-Small Cell Lung Cancer
Drug: Linifanib
Drug: Carboplatin
Drug: Paclitaxel
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • Safety (Number of patients with adverse events and/or dose-limiting toxicities) [ Time Frame: At each treatment visit (weekly for 6 weeks, then every 3 weeks) ] [ Designated as safety issue: No ]
    Evaluation of vital signs, physical exams, clinical lab testing and adverse event monitoring.


Secondary Outcome Measures:
  • Preliminary tumor response [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
    Computed Tomography (CT) scan

  • Preliminary tumor response [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Computed Tomography (CT) scan

  • Preliminary tumor response [ Time Frame: Week 18 ] [ Designated as safety issue: No ]
    Computed Tomography (CT) scan

  • Preliminary tumor response [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    Computed Tomography (CT) scan

  • Preliminary tumor response [ Time Frame: Week 30 ] [ Designated as safety issue: No ]
    Computed Tomography (CT) scan

  • Preliminary tumor response [ Time Frame: Week 36 ] [ Designated as safety issue: No ]
    Computed Tomography (CT) scan

  • Preliminary tumor response [ Time Frame: Week 42 ] [ Designated as safety issue: No ]
    Computed Tomography (CT) scan

  • Preliminary tumor response [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
    Computed Tomography (CT) scan

  • Preliminary tumor response [ Time Frame: Week 54 ] [ Designated as safety issue: No ]
    Computed Tomography (CT) scan


Enrollment: 12
Study Start Date: September 2010
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A Drug: Linifanib
Low dose linifanib (once a day)
Other Name: ABT-869
Drug: Carboplatin
Given on Day 1 of every 21-day cycle
Other Name: Paraplatin
Drug: Paclitaxel
Given on Day 1 of every 21-day cycle
Other Name: Taxol
Experimental: Arm B Drug: Linifanib
High dose linifanib (once a day)
Other Name: ABT-869
Drug: Carboplatin
Given on Day 1 of every 21-day cycle
Other Name: Paraplatin
Drug: Paclitaxel
Given on Day 1 of every 21-day cycle
Other Name: Taxol

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01225302

Locations
Japan
Site Reference ID/Investigator# 43502
Osakasayama, Japan
Site Reference ID/Investigator# 43503
Tokyo, Japan
Site Reference ID/Investigator# 43504
Tokyo, Japan
Sponsors and Collaborators
Abbott
Investigators
Study Director: Susumu Matsuki, BS Abbott Japan Co.,Ltd
  More Information

No publications provided by Abbott

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01225302     History of Changes
Other Study ID Numbers: W12-076
Study First Received: September 28, 2010
Last Updated: July 13, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Carboplatin
Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 21, 2014