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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00743938
First received: August 27, 2008
Last updated: May 31, 2013
Last verified: May 2013

August 27, 2008
May 31, 2013
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 ] [ Designated as safety issue: No ]
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 ] [ 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 ]
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
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.
 
Completed
141
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+
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Poland,   Taiwan,   Spain,   Canada,   France,   Korea, Republic of
 
NCT00743938
CA187-017, EUDRACT #: 2008-004691-44
No
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
May 2013

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