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

• ClinicalTrials.gov Identifier: NCT01167244
• Recruitment Status: Completed
• First Posted: July 22, 2010
• Last Update Posted: October 12, 2015
• Sponsor: Bristol-Myers Squibb
• Information provided by: Bristol-Myers Squibb

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Non-Small-Cell Lung Carcinoma	Drug: BMS-690514	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 11 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (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
• Study Start Date: August 2010
• Actual Primary Completion Date: April 2011
• Actual Study Completion Date: April 2011

Arms and Interventions

Arm	Intervention/treatment
Experimental: BMS-690514	Drug: BMS-690514; Tablets, Oral, 200 mg, once daily, until disease progression or toxicity

Outcome Measures

Primary Outcome Measures :

1. 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 ]
2. 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 ]
3. 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 ]

Secondary Outcome Measures :

1. 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 ]
2. To estimate disease control rate and progression free survival in all treated subjects [ Time Frame: Tumor assessment from Day 29 ]
3. 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 ]
4. To evaluate safety and tolerability of BMS-690514 in all treated subjects [ Time Frame: Average about 10 months ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

• Responsible Party: Study Director, Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT01167244
• Other Study ID Numbers: CA187-020
• First Posted: July 22, 2010
• Last Update Posted: October 12, 2015
• Last Verified: September 2015

Additional relevant MeSH terms:

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