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

NCT ID: NCT00743938

Last Updated: 2015-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

141 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2012-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to improve disease control and survival for patients who were treated with chemotherapy using BMS-690514 over erlotinib

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Non Small Cell Lung Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

A1

Group Type EXPERIMENTAL

BMS-690514

Intervention Type DRUG

Tablets, Oral, 200 mg, once daily, Until disease progression or toxicity

B2

Group Type ACTIVE_COMPARATOR

Erlotinib

Intervention Type DRUG

Capsules, Oral, 150 mg, once daily, Until disease progression or toxicity

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

BMS-690514

Tablets, Oral, 200 mg, once daily, Until disease progression or toxicity

Intervention Type DRUG

Erlotinib

Capsules, Oral, 150 mg, once daily, Until disease progression or toxicity

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

panHER Tarceva

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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+
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Yale University School Of Medicine

New Haven, Connecticut, United States

Site Status

Hematology Oncology, P.C.

Stamford, Connecticut, United States

Site Status

Mass General Hospital

Boston, Massachusetts, United States

Site Status

Henry Ford Hospital

Detroit, Michigan, United States

Site Status

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

Piedmont Hematology Oncology Associates, Pllc

Winston-Salem, North Carolina, United States

Site Status

Oregon Health & Science University

Portland, Oregon, United States

Site Status

Hema/Oncology Assoc. Of Nepa

Dunmore, Pennsylvania, United States

Site Status

Cancer Center Of The Carolinas

Greenville, South Carolina, United States

Site Status

Local Institution

Bahía Blanca, Buenos Aires, Argentina

Site Status

Local Institution

Buenos Aires, Buenos Aires, Argentina

Site Status

Local Institution

La Plata, Buenos Aires, Argentina

Site Status

Local Institution

Córdoba, Córdoba Province, Argentina

Site Status

Local Institution

La Rioja, La Rioja Province, Argentina

Site Status

Local Institution

Montreal, Quebec, Canada

Site Status

Local Institution

Sherbrooke, Quebec, Canada

Site Status

Local Institution

Lyon, , France

Site Status

Local Institution

Marseille, , France

Site Status

Local Institution

Strasbourg, , France

Site Status

Local Institution

Toulouse, , France

Site Status

Local Institution

Villejuif, , France

Site Status

Local Institution

Otwock, , Poland

Site Status

Local Institution

Gyeonggi-do, , South Korea

Site Status

Local Institution

Seoul, , South Korea

Site Status

Local Institution

Seoul, , South Korea

Site Status

Local Institution

Barcelona, , Spain

Site Status

Local Institution

Madrid, , Spain

Site Status

Local Institution

Vizcaya, , Spain

Site Status

Local Institution

Taipei, , Taiwan

Site Status

Local Institution

Taipei, , Taiwan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Argentina Canada France Poland South Korea Spain Taiwan

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

EUDRACT #: 2008-004691-44

Identifier Type: -

Identifier Source: secondary_id

CA187-017

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.