Clinical trial NCT00169533: Rollover Study Of Lapatinib In Cancer Patients
Official title: An Open Label, Phase 1b Rollover Study to Assess the Long-Term Safety Profile of Lapatinib (GW572016) in Cancer Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasms, Breast
Keywords: safety
tolerating lapatinib
Lapatinib
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: To determine the long-term safety and tolerability of lapatinib as monotherapy or in combination regimen
timeFrame: Ongoing study until the new lapatinib rollover study, EGF111767, is approved at the current sites.
Secondary outcomes:
measure: Assess the Long-Term Safety Profile of Lapatinib (GW572016) in Cancer Patients, Overall survival
timeFrame: Ongoing study until the new lapatinib rollover study, EGF111767, is approved at the current sites.
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: GSK Investigational Site
state: Indiana
city: Detroit
country: United States
facility: GSK Investigational Site
state: Michigan
city: Lebanon
country: United States
facility: GSK Investigational Site
state: New Hampshire
city: Albuquerque
country: United States
facility: GSK Investigational Site
state: New Mexico
city: Chapel Hill
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Durham
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Cleveland
country: United States
facility: GSK Investigational Site
state: Ohio
city: Philadelphia
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Nashville
country: United States
facility: GSK Investigational Site
state: Tennessee
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
city: Edmonton
country: Canada
facility: GSK Investigational Site
state: Alberta
city: Tel Aviv
country: Israel
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: