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

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ClinicalTrials.gov Identifier: NCT00743938
Recruitment Status : Completed
First Posted : August 29, 2008
Last Update Posted : October 12, 2015
Information provided by (Responsible Party):
Bristol-Myers Squibb

August 27, 2008
August 29, 2008
October 12, 2015
March 2009
August 2010   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00743938 on ClinicalTrials.gov Archive Site
  • To compare the overall survival between BMS-690514 and erlotinib [ Time Frame: 15 months ]
  • To estimate the overall response rate of BMS-690514 or erlotinib [ Time Frame: 15 months ]
  • To estimate the tumor size change and PFS rate at 6 weeks [ Time Frame: 6 weeks ]
  • To assess safety and tolerability of BMS-690514 and erlotinib [ Time Frame: 15 months ]
  • To estimate the association between efficacy and EGFR copy as measured by FISH for both BMS-690514 and erlotinib [ Time Frame: 15 months ]
  • To obtain samples for population pharmacokinetics for BMS-690514 in previously treated NSCLC patients [ Time Frame: Days 1,8,15, 29 ]
Same as current
Not Provided
Not Provided
A Comparison Between BMS-690514 and Erlotinib in Patients Who Were Previously Treated for NSCLC
A Double-Blind, Randomized, Parallel Two-Arm Phase II Trial of BMS-690514 Versus Erlotinib in Previously Treated NSCLC Patients
The purpose of this study is to improve disease control and survival for patients who were treated with chemotherapy using BMS-690514 over erlotinib
Not Provided
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Non Small Cell Lung Cancer
  • Drug: BMS-690514
    Tablets, Oral, 200 mg, once daily, Until disease progression or toxicity
    Other Name: panHER
  • Drug: Erlotinib
    Capsules, Oral, 150 mg, once daily, Until disease progression or toxicity
    Other Name: Tarceva
  • Experimental: A1
    Intervention: Drug: BMS-690514
  • Active Comparator: B2
    Intervention: Drug: Erlotinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
June 2012
August 2010   (Final data collection date for primary outcome measure)

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+
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Argentina,   Canada,   France,   Korea, Republic of,   Poland,   Spain,   Taiwan,   United States
EUDRACT #: 2008-004691-44
Not Provided
Not Provided
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP