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

Phase 2

Completed

• Conditions: Non-Small-Cell Lung Carcinoma
• Interventions: Drug: BMS-690514

• Registration Number: NCT01167244
• Lead Sponsor: Bristol-Myers Squibb

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 have had a prior a response.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-07-16
• Study First Submitted QC: 2010-07-20
• Study First Posted: 2010-07-22
• Study Start: 2010-08
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Status Verified: 2015-09
• Disposition First Submitted: 2015-09-23
• Disposition First Submitted QC: 2015-09-23
• Last Update Submitted: 2015-09-23
• Disposition First Posted: 2015-10-12
• Last Update Posted: 2015-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BMS-690514	BMS-690514	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Local Institution; 🇯🇵 Koto-Ku, Tokyo, Japan