GW572016 For Treatment Of Refractory Metastatic Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00062686
First received: June 11, 2003
Last updated: April 11, 2013
Last verified: October 2012
  Purpose

This study was designed to determine the efficacy of an oral dual kinase inhibitor for the treatment of metastatic breast cancer tumors that are known to overexpress ErbB2 in a refractory patient population.


Condition Intervention Phase
Neoplasms, Breast
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:
  • Tumor response rate

Secondary Outcome Measures:
  • clinical benefit rate time to progression 4 and 6 month progression free survival overall survival

Estimated Enrollment: 200
Study Start Date: November 2003
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.
  • Histologically confirmed Stage IIIb or IV breast cancer.
  • Refractory breast cancer defined as progression in the metastatic setting after prior therapy with anthracyclines, taxanes and capecitibine.
  • Subjects with documented ErbB2 tumor overexpression must have received at least 6 cycles of trastuzumab.
  • Documented disease progression of the most recent treatment is required.
  • Archived tumor tissue available for testing.
  • Measurable lesions according to Response Evaluation Criteria In Solid Tumors (RECIST).
  • At least 3 weeks since prior cancer therapies except for trastuzumab which must be discontinued at least 2 weeks prior to the beginning of study drug.
  • Bisphosphonate therapy initiated prior to study entry is allowed, however, initiation of bisphosphonates following study entry is not allowed.
  • Able to swallow and retain oral medication.
  • Cardiac ejection fraction within the institutional normal range as measured by echocardiogram or MUGA (Multiple Gated Acquisition) scan.
  • Adequate kidney and liver function.
  • Adequate bone marrow function.

Exclusion criteria:

  • Pregnant or lactating.
  • Copies of nadir scans and/or photographs of the tumor prior to disease progression as well as scans documenting disease progression are not available for review.
  • Malabsorption syndrome, ulcerative colitis, disease significantly affecting gastrointestinal function or resection of the stomach or small bowel.
  • History of other malignancy.
  • Serious medical or psychiatric disorder that would interfere with the patient''s safety or informed consent.
  • Active or uncontrolled infection.
  • Known history of uncontrolled or symptomatic angina, arrhythmias or congestive heart failure.
  • Known history of or clinical evidence of leptomeningeal carcinomatosis.
  • Active infection.
  • Concurrent cancer therapy or investigational therapy.
  • Use of oral or IV steroids.
  • Unresolved or unstable serious toxicity from prior therapy.
  • Prior treatment with an ErbB1 and/or ERbB2 inhibitor other than trastuzumab.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00062686

Locations
Argentina
GSK Investigational Site
Buenos Aires, Argentina, C1455BWU
France
GSK Investigational Site
Villejuif Cedex, France, 94805
Germany
GSK Investigational Site
Augsburg, Bayern, Germany, 86150
United Kingdom
GSK Investigational Site
Sutton, Surrey, United Kingdom, SM2 5PT
GSK Investigational Site
Bebington, Wirral, United Kingdom, CH63 4JY
GSK Investigational Site
London, United Kingdom, SW3 6JJ
GSK Investigational Site
Manchester, United Kingdom, M20 4BX
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00062686     History of Changes
Obsolete Identifiers: NCT00068627
Other Study ID Numbers: EGF20008
Study First Received: June 11, 2003
Last Updated: April 11, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Lapatinib
Metastatic Breast Cancer
HERCEPTIN refractory

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

ClinicalTrials.gov processed this record on April 14, 2014