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A Comparison Between BMS-690514 and Erlotinib in Patients Who Were Previously Treated for NSCLC
This study is ongoing, but not recruiting participants.

First Received on August 27, 2008.   Last Updated on February 2, 2012   History of Changes
Sponsor: Bristol-Myers Squibb
Information provided by: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00743938
  Purpose

The purpose of this study is to improve disease control and survival for patients who were treated with chemotherapy using BMS-690514 over erlotinib


Condition Intervention Phase
Non Small Cell Lung Cancer
 Drug: BMS-690514
Drug: Erlotinib
 Phase II

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, Parallel Two-Arm Phase II Trial of BMS-690514 Versus Erlotinib in Previously Treated NSCLC Patients

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Erlotinib hydrochloride Erlotinib
U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • To compare the progression-free survival of patients on BMS-690514 with those on erlotinib [ Time Frame: CT/MRI at baseline and every 6 weeks for 36 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To compare the overall survival between BMS-690514 and erlotinib [ Time Frame: 15 months ] [ Designated as safety issue: No ]
  • To estimate the overall response rate of BMS-690514 or erlotinib [ Time Frame: 15 months ] [ Designated as safety issue: No ]
  • To estimate the tumor size change and PFS rate at 6 weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • To assess safety and tolerability of BMS-690514 and erlotinib [ Time Frame: 15 months ] [ Designated as safety issue: Yes ]
  • To estimate the association between efficacy and EGFR copy as measured by FISH for both BMS-690514 and erlotinib [ Time Frame: 15 months ] [ Designated as safety issue: No ]
  • To obtain samples for population pharmacokinetics for BMS-690514 in previously treated NSCLC patients [ Time Frame: Days 1,8,15, 29 ] [ Designated as safety issue: No ]

Estimated Enrollment: 140
Study Start Date: March 2009
Estimated Study Completion Date: April 2012
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A1 Drug: BMS-690514
Tablets, Oral, 200 mg, once daily, Until disease progression or toxicity
Other Name: panHER
Active Comparator: B2 Drug: Erlotinib
Capsules, Oral, 150 mg, once daily, Until disease progression or toxicity
Other Name: Tarceva

  Eligibility

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

Inclusion Criteria:

  • ECOG PS of 0 or 1
  • Histologically confirmed NSCLC
  • Adequate amount of tumor (archived or fresh) for biomarker evaluation
  • Received one to two regimens of chemotherapy (with at least one platinum-containing)
  • Serum creatinine of less than 1.0 mg/dL or a 24 hour creatinine clearance of greater than 60 mL/min
  • Stable control of blood pressure on agents other than calcium channel blockers
  • Women of child-bearing potential must avoid pregnancy or maintain adequate contraception
  • Must be able to swallow pills and take the medications at the same time every day on an empty stomach

Exclusion Criteria:

  • ECOG PS 2 or greater
  • Women unwilling to avoid pregnancy or use adequate contraception
  • Symptomatic brain metastases
  • Recent history of TIA, CVA, or thrombotic/thromboembolic event (within 6 months)
  • History of hemoptysis greater than 10 mL/day
  • Significant cardiovascular disease
  • Uncontrolled diarrhea, Crohn's disease, ulcerative colitis, or any malabsorptive disease
  • History of use of other TKIs
  • Uncontrolled hypertension
  • HIV+
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00743938

Locations
United States, Connecticut
Hematology Oncology, P.C.
Stamford, Connecticut, United States, 06902
United States, Massachusetts
Mass General Hospital
Boston, Massachusetts, United States, 02114
United States, North Carolina
Piedmont Hematology Oncology Associates, Pllc
Winston-Salem, North Carolina, United States, 27103
United States, Pennsylvania
Hema/Oncology Assoc. Of Nepa
Dunmore, Pennsylvania, United States, 18512
United States, South Carolina
Cancer Centers Of The Carolinas
Greenville, South Carolina, United States, 29605
Argentina
Local Institution
Bahia Blanca, Buenos Aires, Argentina, 8000
Local Institution
La Plata, Buenos Aires, Argentina, 1900
Local Institution
Buenos Aires, Argentina, 61430ERF
Local Institution
Cordoba, Argentina, 5000
Local Institution
La Rioja, Argentina, 5300
Canada, Quebec
Local Institution
Montreal, Quebec, Canada, H3T 1E2
Local Institution
Sherbrooke, Quebec, Canada, J1H 5N4
France
Local Institution
Lyon Cedex 08, France, 69373
Local Institution
Marseille Cedex 20, France, 13915
Local Institution
Strasbourg, France, 67000
Local Institution
Toulouse, France, 31052
Local Institution
Villejuif Cedex, France, 94800
Korea, Republic of
Local Institution
Gyeonggi-Do, Korea, Republic of, 410-769
Local Institution
Seoul, Korea, Republic of, 138-736
Local Institution
Seoul, Korea, Republic of, 135-710
Poland
Local Institution
Otwock, Poland, 05-400
Spain
Local Institution
Barcelona, Spain, 08035
Local Institution
Madrid, Spain, 28046
Local Institution
Vizcaya, Spain, 48903
Taiwan
Local Institution
Taipei, Taiwan, 112
Local Institution
Taipei, Taiwan, 100
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: NCT00743938     History of Changes
Other Study ID Numbers: CA187-017, EUDRACT #: 2008-004691-44
Study First Received: August 27, 2008
Last Updated: February 2, 2012
Health Authority: United States: Food and Drug Administration

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
Erlotinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012



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