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

September 23, 2015 updated by: Bristol-Myers Squibb

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

141

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Local Institution
      • Cordoba, Argentina, X5000AAI
        • Local Institution
      • La Rioja, Argentina, 5300
        • Local Institution
    • Buenos Aires
      • Bahia Blanca, Buenos Aires, Argentina
        • Local Institution
      • La Plata, Buenos Aires, Argentina, 1900
        • Local Institution
  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Local Institution
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Local Institution
  • France
      • 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
        • Local Institution
  • Korea, Republic of
      • Gyeonggi-do, Korea, Republic of, 410-769
        • Local Institution
      • Seoul, Korea, Republic of, 135-710
        • Local Institution
      • Seoul, Korea, Republic of, 138-736
        • Local Institution
  • Poland
      • Otwock, Poland, 05-400
        • Local Institution
  • Spain
      • Barcelona, Spain, 08035
        • Local Institution
      • Madrid, Spain, 28046
        • Local Institution
      • Vizcaya, Spain, 48903
        • Local Institution
  • Taiwan
      • Taipei, Taiwan, 100
        • Local Institution
      • Taipei, Taiwan, 112
        • Local Institution
  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale University School of Medicine
      • Stamford, Connecticut, United States, 06902-3628
        • Hematology Oncology, P.C.
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Mass General Hospital
    • Michigan
      • Detroit, Michigan, United States, 48202-2689
        • Henry Ford Hospital
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
    • North Carolina
      • Winston-salem, North Carolina, United States, 27103
        • Piedmont Hematology Oncology Associates, PLLC
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University
    • Pennsylvania
      • Dunmore, Pennsylvania, United States, 18512
        • Hema/Oncology Assoc. Of Nepa
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Cancer Center Of The Carolinas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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+

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: A1
Drug: BMS-690514
Tablets, Oral, 200 mg, once daily, Until disease progression or toxicity
Other Names:
  • panHER
ACTIVE_COMPARATOR: B2
Drug: Erlotinib
Capsules, Oral, 150 mg, once daily, Until disease progression or toxicity
Other Names:
  • Tarceva

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
CT/MRI at baseline and every 6 weeks for 36 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
To compare the overall survival between BMS-690514 and erlotinib
Time Frame: 15 months
15 months
To estimate the overall response rate of BMS-690514 or erlotinib
Time Frame: 15 months
15 months
To estimate the tumor size change and PFS rate at 6 weeks
Time Frame: 6 weeks
6 weeks
To assess safety and tolerability of BMS-690514 and erlotinib
Time Frame: 15 months
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
15 months
To obtain samples for population pharmacokinetics for BMS-690514 in previously treated NSCLC patients
Time Frame: Days 1,8,15, 29
Days 1,8,15, 29

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (ACTUAL)

August 1, 2010

Study Completion (ACTUAL)

June 1, 2012

Study Registration Dates

First Submitted

August 27, 2008

First Submitted That Met QC Criteria

August 28, 2008

First Posted (ESTIMATE)

August 29, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

October 12, 2015

Last Update Submitted That Met QC Criteria

September 23, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA187-017
  • EUDRACT #: 2008-004691-44

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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