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Oral Drug Study In Women With Refractory Metastatic Breast Cancer After First-line or Second-line Herceptin.

Sponsor
GlaxoSmithKline (Industry)
Overall Status
Completed
CT.gov ID
NCT00051103
Collaborator
(none)
30
Locations
32
Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the efficacy of an oral investigational drug for the treatment of metastatic breast cancer tumors that are known to overexpress HER2/neu.

Condition or Disease Intervention/Treatment Phase
  • Drug: Investigational Cancer Drug
 Phase 2

Study Design

Study Type:
Interventional
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-Label, Multicenter, Single Arm Phase II Study of Oral GW572016 as Single Agent Therapy in Subjects With Advanced or Metastatic Breast Cancer Who Have Progressed While Receiving Herceptin Containing Regimens
Study Start Date :
Oct 1, 2002
Actual Primary Completion Date :
Jun 1, 2005
Actual Study Completion Date :
Jun 1, 2005

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No

    Inclusion Criteria: (The patient must meet the following criteria in order to be eligible for this study.)

    • Signed informed consent

    • No more than two prior regimens for metastatic breast cancer. Each regimen must have contained Herceptin.

    • Refractory Stage IIIb or IV breast cancer

    • HER2/neu tumor overexpression

    • Disease progression while receiving a prior chemotherapy regimen with Herceptin alone or in combination with other chemotherapy.

    • Tumor tissue available for testing.

    • 2 weeks since treatment with Herceptin (alone or in combination).

    • 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: (The patient cannot meet any of the following criteria in order to be eligible for this study.)

    • Prior regimens did not include Herceptin.

    • Pregnant or lactating.

    • Conditions that would affect absorption of an oral drug

    • Serious medical or psychiatric disorder that would interfere with the patient's safety or informed consent.

    • Severe cardiovascular disease or cardiac disease requiring a device.

    • Active infection.

    • Brain metastases.

    • Concurrent cancer therapy or investigational therapy.

    • Use of oral or IV steroids.

    • Unresolved or unstable serious toxicity from prior therapy.

    • Treatment with EGFR (Endothelial Growth Factor Receptor) inhibitor other than Herceptin.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 GSK Investigational Site Chula Vista California United States 91911
    2 GSK Investigational Site Los Angeles California United States 90095
    3 GSK Investigational Site Poway California United States 92064
    4 GSK Investigational Site Fort Myers Florida United States 33901
    5 GSK Investigational Site Plantation Florida United States 33324
    6 GSK Investigational Site Savannah Georgia United States 31405
    7 GSK Investigational Site Park Ridge Illinois United States 60068
    8 GSK Investigational Site Skokie Illinois United States 60076
    9 GSK Investigational Site Skokie Illinois United States 60077
    10 GSK Investigational Site Bettendorf Iowa United States 52722
    11 GSK Investigational Site Des Moines Iowa United States 50309
    12 GSK Investigational Site Baltimore Maryland United States 21201
    13 GSK Investigational Site Royal Oak Michigan United States 48073
    14 GSK Investigational Site Billings Montana United States 59101
    15 GSK Investigational Site Hooksett New Hampshire United States 03106
    16 GSK Investigational Site Durham North Carolina United States 27710
    17 GSK Investigational Site Greenville North Carolina United States 27834
    18 GSK Investigational Site Hickory North Carolina United States 28602
    19 GSK Investigational Site Fargo North Dakota United States 58103
    20 GSK Investigational Site Oklahoma City Oklahoma United States 73112
    21 GSK Investigational Site Tulsa Oklahoma United States 74136
    22 GSK Investigational Site Pittsburgh Pennsylvania United States 15213
    23 GSK Investigational Site Columbia South Carolina United States 29210
    24 GSK Investigational Site Germantown Tennessee United States 38138
    25 GSK Investigational Site Memphis Tennessee United States 38104
    26 GSK Investigational Site Memphis Tennessee United States 38120
    27 GSK Investigational Site Nashville Tennessee United States 37203
    28 GSK Investigational Site Nashville Tennessee United States 37205
    29 GSK Investigational Site Houston Texas United States 77025
    30 GSK Investigational Site Salem Virginia United States 24153

    Sponsors and Collaborators

    • GlaxoSmithKline

    Investigators

    • Study Director: GSK Clinical Trials, GlaxoSmithKline

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    GlaxoSmithKline
    ClinicalTrials.gov Identifier:
    NCT00051103
    Other Study ID Numbers:
    • EGF 20002
    • NCT00044330
    • NCT00053066
    First Posted:
    Jan 6, 2003
    Last Update Posted:
    Apr 15, 2015
    Last Verified:
    Apr 1, 2015
    Keywords provided by GlaxoSmithKline
    Refractory
    Additional relevant MeSH terms:
    Breast Neoplasms
    Antineoplastic Agents

    Study Results

    No Results Posted as of Apr 15, 2015