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

Non-Small-Cell Lung Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01167244
• Other study ID #: CA187-020
• Status: Completed
• Phase: Phase 2
• First received: July 16, 2010
• Last updated: September 23, 2015
• Start date: August 2010
• Est. completion date: April 2011

Study information

• Verified date: September 2015
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices AgencyKorea: Food and Drug AdministrationTaiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small-Cell Lung Carcinoma

Intervention

Drug:
• BMS-690514
Tablets, Oral, 200 mg, once daily, until disease progression or toxicity

Locations

Country	Name	City	State
Japan	Local Institution	Kashiwa-Shi	Chiba
Japan	Local Institution	Koto-Ku	Tokyo
Japan	Local Institution	Osaka-Sayama-Shi	Osaka
Japan	Local Institution	Sunto-Gun	Shizuoka

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	To estimate disease control rate and progression free survival in all treated subjects		Tumor assessment from Day 29	No
Secondary	To estimate disease control rate and progression free survival in all treated subjects		Tumor assessment every 8 weeks from Day 1 until disease progression	No
Secondary	To evaluate safety and tolerability of BMS-690514 in all treated subjects		Average about 10 months	Yes

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form