Trial of BMS-690514 in Non-Small Cell Lung Cancer Subjects Who Have Been Treated With Gefitinib or Erlotinib and Are Genotypically EGFR Mutation Positive or Who Have Had a Prior Response

Study Overview
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Brief Summary
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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.

Official Title
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Phase 2 Trial of BMS-690514 in Non-Small Cell Lung Cancer Subjects Who Have Been Treated With Gefitinib or Erlotinib and Are Genotypically EGFR Mutation Positive or Who Have Had a Prior Response

Conditions
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Non-Small-Cell Lung Carcinoma

Intervention / Treatment
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* Drug: BMS-690514


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Recurrent, metastatic or progressive NSCLC without any indication of radiotherapy. Subjects must have: Pathologically confirmed NSCLC Previously received treatment with single agent Gefitinib or Erlotinib and completed treatment at least 2 weeks prior to study entry Any one of the following: A tumor that harbors an EGFR mutation Objective clinical benefit from treatment with Gefitinib or Erlotinib as defined by either documented and confirmed partial or complete response (RECIST or WHO), or significant and durable (≥ 6 months) clinical benefit (stable disease as defined by RECIST or WHO) Progression of NSCLC while on continuous treatment with gefitinib or erlotinib as noted by CT/MRI increase in disease after having a confirmed partial or complete response or evidence of ≥ 6 months of SD within 3 months of study enrollment Exclusion Criteria: Symptomatic brain metastasis History of TIA, CVA, or thrombotic/thromboembolic event (within last 6 months) History of hemoptysis greater than 10 mL/day within last 30 days Uncontrolled or significant cardiovascular disease History of uncontrolled diarrhea, Crohn's disease or ulcerative colitis Inability to swallow tablets, untreated malabsorption or GI surgery that results in inability to absorb protocol therapy Women unwilling to avoid pregnancy or use adequate contraception History of allergy or adverse drug reaction to gefitinib or erlotinib

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BMS-690514<br> | Drug: BMS-690514<br>* Tablets, Oral, 200 mg, once daily, until disease progression or toxicity<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 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 |  | 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 |  | Tumor assessments every 8 weeks from Day 1 by CT or MRI | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To estimate disease control rate and progression free survival in all treated subjects |  | 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 |  | Tumor assessment from Day 29 | 
| To estimate disease control rate and progression free survival in all treated subjects |  | Tumor assessment every 8 weeks from Day 1 until disease progression | 
| To evaluate safety and tolerability of BMS-690514 in all treated subjects |  | Average about 10 months |