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A Comparison Between BMS-690514 and Erlotinib in Patients Who Were Previously Treated for NSCLC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00743938
Recruitment Status : Completed
First Posted : August 29, 2008
Last Update Posted : October 12, 2015
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
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 or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Drug: BMS-690514 Drug: Erlotinib Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 141 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : March 2009
Actual Primary Completion Date : August 2010
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. To compare the overall survival between BMS-690514 and erlotinib [ Time Frame: 15 months ]
  2. To estimate the overall response rate of BMS-690514 or erlotinib [ Time Frame: 15 months ]
  3. To estimate the tumor size change and PFS rate at 6 weeks [ Time Frame: 6 weeks ]
  4. To assess safety and tolerability of BMS-690514 and erlotinib [ Time Frame: 15 months ]
  5. To estimate the association between efficacy and EGFR copy as measured by FISH for both BMS-690514 and erlotinib [ Time Frame: 15 months ]
  6. To obtain samples for population pharmacokinetics for BMS-690514 in previously treated NSCLC patients [ Time Frame: Days 1,8,15, 29 ]


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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:

  • 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+

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): NCT00743938


Locations
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United States, Connecticut
Yale University School Of Medicine
New Haven, Connecticut, United States, 06520
Hematology Oncology, P.C.
Stamford, Connecticut, United States, 06902-3628
United States, Massachusetts
Mass General Hospital
Boston, Massachusetts, United States, 02114
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202-2689
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, North Carolina
Piedmont Hematology Oncology Associates, Pllc
Winston-salem, North Carolina, United States, 27103
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
Hema/Oncology Assoc. Of Nepa
Dunmore, Pennsylvania, United States, 18512
United States, South Carolina
Cancer Center Of The Carolinas
Greenville, South Carolina, United States, 29605
Argentina
Local Institution
Bahia Blanca, Buenos Aires, Argentina
Local Institution
La Plata, Buenos Aires, Argentina, 1900
Local Institution
Buenos Aires, Argentina
Local Institution
Cordoba, Argentina, X5000AAI
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, 135-710
Local Institution
Seoul, Korea, Republic of, 138-736
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, 100
Local Institution
Taipei, Taiwan, 112
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00743938    
Other Study ID Numbers: CA187-017
EUDRACT #: 2008-004691-44
First Posted: August 29, 2008    Key Record Dates
Last Update Posted: October 12, 2015
Last Verified: September 2015
Additional relevant MeSH terms:
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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
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action