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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


Phase 1
20 Years
N/A
Not Enrolling
Both
Non-Small Cell Lung Cancer

Thank you

Trial Information

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

Inclusion 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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Safety (Number of patients with adverse events and/or dose-limiting toxicities)

Outcome Description:

Evaluation of vital signs, physical exams, clinical lab testing and adverse event monitoring.

Outcome Time Frame:

At each treatment visit (weekly for 6 weeks, then every 3 weeks)

Safety Issue:

No

Principal Investigator

Susumu Matsuki, BS

Investigator Role:

Study Director

Investigator Affiliation:

Abbott Japan Co.,Ltd

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

W12-076

NCT ID:

NCT01225302

Start Date:

September 2010

Completion Date:

June 2012

Related Keywords:

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

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