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 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

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.

Study Overview

• Status: Completed
• Conditions: Non-Small-Cell Lung Carcinoma
• Intervention / Treatment: Drug: BMS-690514

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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
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
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

Outcome Measure	Time Frame
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
To estimate disease control rate and progression free survival in all treated subjects	Tumor assessment from Day 29
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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): April 1, 2011
• Study Completion (Actual): April 1, 2011

Study Registration Dates

• First Submitted: July 16, 2010
• First Submitted That Met QC Criteria: July 20, 2010
• First Posted (Estimate): July 22, 2010

Study Record Updates

• Last Update Posted (Estimate): October 12, 2015
• Last Update Submitted That Met QC Criteria: September 23, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: CA187-020