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Completed

NCT Number: NCT00169533

Rollover Study Of Lapatinib In Cancer Patients

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.

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Key information

Conditions

Neoplasms, Breast Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site, Edmonton, Alberta, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GW572016 oral tablets

Drug

Lapatinib either at 750, 1000, 1250 or 1500 mgs

Primary outcomes

  1. To determine the long-term safety and tolerability of lapatinib as monotherapy or in combination regimen

    Time frame: Ongoing study until the new lapatinib rollover study, EGF111767, is approved at the current sites.

Secondary outcomes

  1. Assess the Long-Term Safety Profile of Lapatinib (GW572016) in Cancer Patients, Overall survival

    Time frame: Ongoing study until the new lapatinib rollover study, EGF111767, is approved at the current sites.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2009
Study completion
2009
First posted
Sep 15, 2005
Registry last updated
Nov 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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