The purpose of this study is to observe an improvement in overall response rate in NSCLC subjects who have been treated with gefitinib or erlotinib and are genotypically EGFR mutation positive or who have had a prior a response.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
11
Tablets, Oral, 200 mg, once daily, until disease progression or toxicity
Local Institution
Kashiwa-Shi, Chiba, Japan
Local Institution
Osaka-Sayama-Shi, Osaka, Japan
Local Institution
Sunto-Gun, Shizuoka, Japan
Local Institution
Koto-Ku, Tokyo, Japan
To estimate objective response rate in NSCLC subjects who have been treated with gefitinib or erlotinib and are genotypically EGFR mutation positive or who have had a prior a response
Time frame: Tumor assessment Day 29 and every 8 weeks from Day 1 thereafter until disease progression
To estimate objective response rate in NSCLC subjects who have been treated with gefitinib or erlotinib and are genotypically EGFR mutation positive or who have had a prior a response
Time frame: Tumor assesments on Day 29 by CT or MRI
To estimate objective response rate in NSCLC subjects who have been treated with gefitinib or erlotinib and are genotypically EGFR mutation positive or who have had a prior a response
Time frame: Tumor assessments every 8 weeks from Day 1 by CT or MRI
To estimate disease control rate and progression free survival in all treated subjects
Time frame: Tumor assessment Day 29 and every 8 weeks from Day 1 thereafter until disease progression
To estimate disease control rate and progression free survival in all treated subjects
Time frame: Tumor assessment from Day 29
To estimate disease control rate and progression free survival in all treated subjects
Time frame: Tumor assessment every 8 weeks from Day 1 until disease progression
To evaluate safety and tolerability of BMS-690514 in all treated subjects
Time frame: Average about 10 months
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