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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00051103
First received: January 3, 2003
Last updated: July 19, 2012
Last verified: March 2011
  Purpose

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 Intervention Phase
Metastatic Breast Cancer
Neoplasms, Breast
Drug: Investigational Cancer Drug
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Study Start Date: October 2002
Intervention Details:
    Drug: Investigational Cancer Drug
    Other Name: Investigational Cancer Drug
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00051103

  Show 30 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications:
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00051103     History of Changes
Other Study ID Numbers: EGF 20002
Study First Received: January 3, 2003
Last Updated: July 19, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Refractory

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Trastuzumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014