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GW572016, An Oral Drug For Women With Refractory Metastatic Breast Cancer After First-line Or Second-line Herceptin

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00044330
First received: August 26, 2002
Last updated: October 1, 2010
Last verified: October 2010
  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
Drug: GW572016
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:

Primary Outcome Measures:
  • Response rate [ Time Frame: throughout the study ]

Secondary Outcome Measures:
  • Time to Response Duration of response Time to progression Progression-free survival Overall survival [ Time Frame: all throughout the study ]

Enrollment: 80
Study Start Date: October 2002
Study Completion Date: June 2005
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: GW572016
    Other Name: GW572016
  Eligibility

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

Inclusion criteria:

  • 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) or Echocardiogram.
  • Adequate kidney and liver function
  • Adequate bone marrow function

Exclusion criteria:

  • 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 and/or Her2-neu 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: NCT00044330

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

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00044330     History of Changes
Obsolete Identifiers: NCT00053066
Other Study ID Numbers: EGF20002
Study First Received: August 26, 2002
Last Updated: October 1, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
lapatinib
metastatic breast cancer
EGFR,
Her2-neu
ErbB2
kinase inhibitor

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Lapatinib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014