Rollover Study Of Lapatinib In Cancer Patients

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00169533

Enrollment

Registered

2005-09-15

Start date

2004-08-19

Completion date

2009-05-05

Last updated

2017-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neoplasms, Breast

Keywords

safety, tolerating lapatinib, Lapatinib

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.

Interventions

DRUGGW572016 oral tablets

Lapatinib either at 750, 1000, 1250 or 1500 mgs

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.

Countries

Canada, Israel, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026