GW572016 For Treatment Of Refractory Metastatic Breast Cancer - Tabular View

Tracking Information

First Received Date ^ICMJE

June 11, 2003

Last Updated Date

May 28, 2009

Start Date ^ICMJE

November 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Tumor response rate

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00062686 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

clinical benefit rate time to progression 4 and 6 month progression free survival overall survival

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

GW572016 For Treatment Of Refractory Metastatic Breast Cancer

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Metastatic Breast Cancer

Intervention ^ICMJE

Drug: GW572016

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

200

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Argentina, Australia, Belgium, Canada, France, Germany, Japan, Spain, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00062686

Responsible Party

Study Director, GSK

Study ID Numbers ^ICMJE

EGF20008

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

May 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP