Text Size

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

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01167244
First received: July 16, 2010
Last updated: July 18, 2011
Last verified: July 2011
History of Changes
  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: Cancer 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
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
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Lung Diseases
Respiratory Tract Diseases
Gefitinib
Erlotinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 17, 2013