Rollover Study Of Lapatinib In Cancer Patients

Neoplasms, Breast Clinical Trial

Official title:

An Open Label, Phase 1b Rollover Study to Assess the Long-Term Safety Profile of Lapatinib (GW572016) in Cancer Patients.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00169533
• Other study ID #: EGF19060
• Status: Completed
• Phase: Phase 1
• First received: September 9, 2005
• Last updated: November 13, 2017
• Start date: August 19, 2004
• Est. completion date: May 5, 2009

Study information

• Verified date: November 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The EGF19060 study is a rollover study to evaluate the long term safety of lapatinib and to provide lapatinib to patients who had a positive response in previous lapatinib studies until lapatinib is available pending FDA approval.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: May 5, 2009
• Est. primary completion date: May 5, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Currently receiving clinical benefit as defined by CR, PR or SD from treatment with lapatinib through participation in a Phase I study of lapatinib either as monotherapy or as part of a combination regimen.

• Ability to understand and provide written informed consent to participate in this trial.

• Is male or female.

• Female and male subjects agree to the protocol specific birth control measures

Exclusion Criteria:

• Permanent discontinuation of lapatinib in the previous study due to intolerance or treatment failure.

• Is a pregnant or lactating female.

• Is considered medically unfit for the study by the investigator as a result of the medical interview, physical exam, or screening investigations.

• Currently receiving treatment with any medications listed on the prohibited medication list (see Section 7.2).

• Has Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system.

• Has a left ventricular ejection fraction (LVEF) < 40% based on MUGA or ECHO.

Related Conditions & MeSH terms

• Breast Neoplasms
• Neoplasms, Breast

Intervention

Drug:
• GW572016 oral tablets
Lapatinib either at 750, 1000, 1250 or 1500 mgs

Locations

Country	Name	City	State
Canada	GSK Investigational Site	Edmonton	Alberta
Israel	GSK Investigational Site	Tel Aviv
United States	GSK Investigational Site	Albuquerque	New Mexico
United States	GSK Investigational Site	Chapel Hill	North Carolina
United States	GSK Investigational Site	Cleveland	Ohio
United States	GSK Investigational Site	Detroit	Michigan
United States	GSK Investigational Site	Durham	North Carolina
United States	GSK Investigational Site	Indianapolis	Indiana
United States	GSK Investigational Site	Lebanon	New Hampshire
United States	GSK Investigational Site	Nashville	Tennessee
United States	GSK Investigational Site	Philadelphia	Pennsylvania
United States	GSK Investigational Site	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Canada,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the long-term safety and tolerability of lapatinib as monotherapy or in combination regimen		Ongoing study until the new lapatinib rollover study, EGF111767, is approved at the current sites.
Secondary	Assess the Long-Term Safety Profile of Lapatinib (GW572016) in Cancer Patients, Overall survival		Ongoing study until the new lapatinib rollover study, EGF111767, is approved at the current sites.

External Links

•   Results for study EGF19060 can be found on the GSK Clinical Study Register.