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CompletedPhase 2NCT00743938
Official study title

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

Study 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

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedBMS-690514 and Erlotinib

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Oct 12, 2015 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?30 U.S. locations

Locations may change over time.

Who runs it?Bristol-Myers Squibb

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Bristol-Myers Squibb
Interventions being studied
Drug: BMS-690514; Drug: Erlotinib
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Treatment approach
Chemotherapy→
Study topics
After prior treatment→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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
Reasons someone may not be able to joinExclusion 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+

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Yale University School Of MedicineNew Haven, Connecticut
  • Hematology Oncology, P.C.Stamford, Connecticut
  • Mass General HospitalBoston, Massachusetts
  • Henry Ford HospitalDetroit, Michigan
  • Memorial Sloan Kettering Cancer CenterNew York, New York
  • Piedmont Hematology Oncology Associates, PllcWinston-Salem, North Carolina
  • Oregon Health & Science UniversityPortland, Oregon
  • Hema/Oncology Assoc. Of NepaDunmore, Pennsylvania
  • Cancer Center Of The CarolinasGreenville, South Carolina
  • Local InstitutionBahía Blanca, Buenos Aires
  • Local InstitutionBuenos Aires, Buenos Aires
  • Local InstitutionLa Plata, Buenos Aires

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 12, 2015. Always confirm current availability with the study team.

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