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 - Full Text View

Purpose

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.

Condition	Intervention	Phase
Non-Small-Cell Lung Carcinoma	Drug: BMS-690514	Phase 2


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

Resource links provided by NLM:

MedlinePlus related topics: Lung Cancer

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

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 [ Time Frame: Tumor assessment Day 29 and every 8 weeks from Day 1 thereafter until disease progression ] [ Designated as safety issue: No ]
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 [ Time Frame: Tumor assesments on Day 29 by CT or MRI ] [ Designated as safety issue: No ]
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 [ Time Frame: Tumor assessments every 8 weeks from Day 1 by CT or MRI ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To estimate disease control rate and progression free survival in all treated subjects [ Time Frame: Tumor assessment Day 29 and every 8 weeks from Day 1 thereafter until disease progression ] [ Designated as safety issue: No ]
To estimate disease control rate and progression free survival in all treated subjects [ Time Frame: Tumor assessment from Day 29 ] [ Designated as safety issue: No ]
To estimate disease control rate and progression free survival in all treated subjects [ Time Frame: Tumor assessment every 8 weeks from Day 1 until disease progression ] [ Designated as safety issue: No ]
To evaluate safety and tolerability of BMS-690514 in all treated subjects [ Time Frame: Average about 10 months ] [ Designated as safety issue: Yes ]


Enrollment:	11
Study Start Date:	August 2010
Study Completion Date:	April 2011
Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: BMS-690514	Drug: BMS-690514 Tablets, Oral, 200 mg, once daily, until disease progression or toxicity

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01167244

Locations


Japan
Local Institution
Kashiwa-Shi, Chiba, Japan, 2778577
Local Institution
Osaka-Sayama-Shi, Osaka, Japan, 5898511
Local Institution
Sunto-Gun, Shizuoka, Japan, 4118777
Local Institution
Koto-Ku, Tokyo, Japan, 1358550

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators


Study Director:	Bristol-Myers Squibb	Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

Investigator Inquiry form This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

No publications provided


Responsible Party:	Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT01167244 History of Changes
Other Study ID Numbers:	CA187-020
Study First Received:	July 16, 2010
Last Updated:	July 18, 2011
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency Korea: Food and Drug Administration Taiwan: Department of Health

Additional relevant MeSH terms:


Carcinoma, Non-Small-Cell Lung Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms	Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

ClinicalTrials.gov processed this record on February 27, 2015