GW572016 For Treatment Of Refractory Metastatic Breast Cancer

Neoplasms, Breast Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00062686
• Other study ID #: EGF20008
• Status: Completed
• Phase: Phase 2
• First received: June 11, 2003
• Last updated: April 14, 2015
• Start date: November 2003
• Est. completion date: February 2005

Study information

• Verified date: April 2015
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT00068627

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: February 2005
• Est. primary completion date: February 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms
• Neoplasms, Breast

Intervention

Drug:
• GW572016

Locations

Country	Name	City	State
Argentina	GSK Investigational Site	Buenos Aires
France	GSK Investigational Site	Villejuif Cedex
Germany	GSK Investigational Site	Augsburg	Bayern
United Kingdom	GSK Investigational Site	Bebington, Wirral
United Kingdom	GSK Investigational Site	London
United Kingdom	GSK Investigational Site	Manchester
United Kingdom	GSK Investigational Site	Sutton	Surrey

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Argentina,  France,  Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor response rate
Secondary	clinical benefit rate time to progression 4 and 6 month progression free survival overall survival