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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

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

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

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


Outcome Measures
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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
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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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Additional Information:
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

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

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
 Lung Diseases
Respiratory Tract Diseases
Gefitinib
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action