Clinical trial NCT01167244: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Small-Cell Lung Carcinoma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2010-07-22
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Tumor assessment Day 29 and every 8 weeks from Day 1 thereafter until disease progression
measure: 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
timeFrame: Tumor assesments on Day 29 by CT or MRI
measure: 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
timeFrame: Tumor assessments every 8 weeks from Day 1 by CT or MRI
Secondary outcomes:
measure: To estimate disease control rate and progression free survival in all treated subjects
timeFrame: Tumor assessment Day 29 and every 8 weeks from Day 1 thereafter until disease progression
measure: To estimate disease control rate and progression free survival in all treated subjects
timeFrame: Tumor assessment from Day 29
measure: To estimate disease control rate and progression free survival in all treated subjects
timeFrame: Tumor assessment every 8 weeks from Day 1 until disease progression
measure: To evaluate safety and tolerability of BMS-690514 in all treated subjects
timeFrame: Average about 10 months
Other outcomes:
Locations:
city: Kashiwa-Shi
country: Japan
facility: Local Institution
state: Chiba
city: Osaka-Sayama-Shi
country: Japan
facility: Local Institution
state: Osaka
city: Sunto-Gun
country: Japan
facility: Local Institution
state: Shizuoka
city: Koto-Ku
country: Japan
facility: Local Institution
state: Tokyo
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: