GW572016, An Oral Drug For Colorectal Cancer Patients Having Prior Therapy With 5-FU Plus CPT-11 And/Or Oxaliplatin

July 9, 2014 updated by: GlaxoSmithKline

An Open-Label, Multicenter, Phase II Study of Oral Lapatinib (GW572016) as Single Agent, Second-Line Therapy in Subjects With Metastatic Colorectal Cancer Who Have Progressed on First-Line Therapy With 5-Fluorouracil in Combination With Irinotecan or Oxaliplatin

The purpose of this study is to determine the efficacy of an oral investigational drug in patients with refractory metastatic colorectal cancer after receiving prior therapy with 5-fluorouracil in combination with irinotecan and/or oxaliplatin.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • GSK Clinical Trials Call Center
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2H 2A6
        • GSK Clinical Trials Call Center
    • Ontario
      • Sudbury, Ontario, Canada, P3E 5J1
        • GSK Clinical Trials Call Center
      • Thunder Bay, Ontario, Canada, P7A 7T1
        • GSK Clinical Trials Call Center
    • Quebec
      • Levis, Quebec, Canada, G6V 3Z1
        • GSK Clinical Trials Call Center
      • Montreal, Quebec, Canada, H4J1C5
        • GSK Clinical Trials Call Center
      • Sainte-Foy, Quebec, Canada, G1V 4G5
        • GSK Clinical Trials Call Center
  • United States
    • California
      • Los Angeles, California, United States, 90095
        • GSK Clinical Trials Call Center
      • Poway, California, United States, 92064
        • GSK Clinical Trials Call Center
    • Connecticut
      • Torrington, Connecticut, United States, 06790
        • GSK Clinical Trials Call Center
    • Florida
      • Boca Raton, Florida, United States, 33428
        • GSK Clinical Trials Call Center
      • Fort Lauderdale, Florida, United States, 33308
        • GSK Clinical Trials Call Center
      • Fort Myers, Florida, United States, 33901
        • GSK Clinical Trials Call Center
      • Miami, Florida, United States, 33138
        • GSK Clinical Trials Call Center
      • Sarasota, Florida, United States, 34239
        • GSK Clinical Trials Call Center
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • GSK Clinical Trials Call Center
      • Marietta, Georgia, United States, 30060
        • GSK Clinical Trials Call Center
    • Indiana
      • Terre Haute, Indiana, United States, 47802
        • GSK Clinical Trials Call Center
    • Iowa
      • Des Moines, Iowa, United States, 50314
        • GSK Clinical Trials Call Center
    • Louisiana
      • Lafayette, Louisiana, United States, 70506
        • GSK Clinical Trials Call Center
      • New Orleans, Louisiana, United States, 70121
        • GSK Clinical Trials Call Center
    • Maryland
      • Rockville, Maryland, United States, 20850
        • GSK Clinical Trials Call Center
    • Massachusetts
      • Wellesley, Massachusetts, United States, 02481
        • GSK Clinical Trials Call Center
    • Missouri
      • St. Charles, Missouri, United States, 63301
        • GSK Clinical Trials Call Center
      • St. Joseph, Missouri, United States, 64507
        • GSK Clinical Trials Call Center
      • St. Louis, Missouri, United States, 63136
        • GSK Clinical Trials Call Center
    • Montana
      • Billings, Montana, United States, 59101
        • GSK Clinical Trials Call Center
      • Great Falls, Montana, United States, 59405
        • GSK Clinical Trials Call Center
    • Nebraska
      • Omaha, Nebraska, United States, 68198-7680
        • GSK Clinical Trials Call Center
    • New Hampshire
      • Hooksett, New Hampshire, United States, 03106-2505
        • GSK Clinical Trials Call Center
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • GSK Clinical Trials Call Center
      • Summit, New Jersey, United States, 07091
        • GSK Clinical Trials Call Center
    • New York
      • Armonk, New York, United States, 10504
        • GSK Clinical Trials Call Center
      • Brooklyn, New York, United States, 11235
        • GSK Clinical Trials Call Center
      • New York, New York, United States, 10032
        • GSK Clinical Trials Call Center
      • Rockville Centre, New York, United States, 11570
        • GSK Clinical Trials Call Center
      • White Plains, New York, United States, 10601
        • GSK Clinical Trials Call Center
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • GSK Clinical Trials Call Center
      • Goldsboro, North Carolina, United States, 27534
        • GSK Clinical Trials Call Center
      • Greensboro, North Carolina, United States, 27403
        • GSK Clinical Trials Call Center
      • Greenville, North Carolina, United States, 27834
        • GSK Clinical Trials Call Center
      • Hickory, North Carolina, United States, 28602
        • GSK Clinical Trials Call Center
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • GSK Clinical Trials Call Center
    • Pennsylvania
      • Altoona, Pennsylvania, United States, 16601
        • GSK Clinical Trials Call Center
      • Bethlehem, Pennsylvania, United States, 18015
        • GSK Clinical Trials Call Center
      • Hershey, Pennsylvania, United States, 17033
        • GSK Clinical Trials Call Center
      • Kingston, Pennsylvania, United States, 18704
        • GSK Clinical Trials Call Center
      • Lancaster, Pennsylvania, United States, 17605
        • GSK Clinical Trials Call Center
    • South Carolina
      • Spartanburg, South Carolina, United States, 29303
        • GSK Clinical Trials Call Center
      • West Columbia, South Carolina, United States, 29169
        • GSK Clinical Trials Call Center
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • GSK Clinical Trials Call Center
      • Nashville, Tennessee, United States, 37203
        • GSK Clinical Trials Call Center
      • Nashville, Tennessee, United States, 37205
        • GSK Clinical Trials Call Center
    • Washington
      • Burien, Washington, United States, 98166
        • GSK Clinical Trials Call Center
      • Olympia, Washington, United States, 98502
        • GSK Clinical Trials Call Center
      • Puyallup, Washington, United States, 98372
        • GSK Clinical Trials Call Center
      • Yakima, Washington, United States, 98902
        • GSK Clinical Trials Call Center

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Provide signed informed consent.
  • Refractory Stage IV metastatic colorectal cancer.
  • Received at least 2 cycles of first-line therapy with intravenous 5-FU (5-fluorouracil) in combination with CPT-11 (irinotecan) and/or oxaliplatin.
  • No more than one prior therapy.
  • Tumor tissue available for testing.
  • 4 weeks since first-line cancer regimen.
  • Able to swallow and retain oral medication.
  • Cardiac ejection fraction within the institutional range of normal as measured by MUGA (Multiple Gated Acquisition Scan).
  • Adequate kidney and liver function.
  • Adequate bone marrow function.

Exclusion Criteria:

  • Pregnant or lactating female.
  • Conditions that would affect absorption of an oral drug
  • First-line regimen did not include 5-fluorouracil with irinotecan and/or oxaliplatin.
  • Serious medical or psychiatric disorder that would interfere with the patient''s safety or informed consent.
  • Severe cardiovascular disease or cardiac (heart) disease requiring a device.
  • Active infection.
  • Brain metastases.
  • Concurrent cancer therapy or investigational therapy.
  • Use of oral or intravenous steroids.
  • Unresolved or unstable, serious toxicity from prior therapy.
  • Prior therapy with an EGFR (Endothelial Growth Factor Receptor) and/or erbB-2 inhibitor.

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Tumor response rate (complete or partial).
Time Frame: 6 Months
6 Months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Time to response duration of response time to progression 4-month progression-free survival 6-month progression-free survival overall survival safety data biomarkers
Time Frame: 6 Month
6 Month

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GlaxoSmithKline

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: GSK Clinical Trial, MD, GlaxoSmithKline

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2002

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2003

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2003

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 26, 2002

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2002

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 28, 2002

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 10, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EGF20004

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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