Status:
COMPLETED
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
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Non-Small-Cell Lung Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT01167244
Start Date
August 1 2010
End Date
April 1 2011
Last Update
October 12 2015
Active Locations (4)
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1
Local Institution
Kashiwa-Shi, Chiba, Japan, 2778577
2
Local Institution
Osaka-Sayama-Shi, Osaka, Japan, 5898511
3
Local Institution
Sunto-Gun, Shizuoka, Japan, 4118777
4
Local Institution
Koto-Ku, Tokyo, Japan, 1358550