Rollover Study Of Lapatinib In Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00169533
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : November 17, 2017
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Neoplasms, Breast Drug: GW572016 oral tablets Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, Phase 1b Rollover Study to Assess the Long-Term Safety Profile of Lapatinib (GW572016) in Cancer Patients.
Actual Study Start Date : August 19, 2004
Actual Primary Completion Date : May 5, 2009
Actual Study Completion Date : May 5, 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Arm 1
Lapatinib either 750, 1000, 1250 or 1500 mgs
Drug: GW572016 oral tablets
Lapatinib either at 750, 1000, 1250 or 1500 mgs

Primary Outcome Measures :
  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 Outcome Measures :
  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. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00169533

United States, Indiana
GSK Investigational Site
Indianapolis, Indiana, United States, 46202
United States, Michigan
GSK Investigational Site
Detroit, Michigan, United States, 48201
United States, New Hampshire
GSK Investigational Site
Lebanon, New Hampshire, United States, 03756
United States, New Mexico
GSK Investigational Site
Albuquerque, New Mexico, United States, 87131
United States, North Carolina
GSK Investigational Site
Chapel Hill, North Carolina, United States, 27599
GSK Investigational Site
Durham, North Carolina, United States, 27705
United States, Ohio
GSK Investigational Site
Cleveland, Ohio, United States, 44106
United States, Pennsylvania
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19111
United States, Tennessee
GSK Investigational Site
Nashville, Tennessee, United States, 37203
United States, Texas
GSK Investigational Site
San Antonio, Texas, United States, 78229
Canada, Alberta
GSK Investigational Site
Edmonton, Alberta, Canada, T6G 1Z2
GSK Investigational Site
Tel Aviv, Israel, 64239
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline

Additional Information:
Responsible Party: GlaxoSmithKline Identifier: NCT00169533     History of Changes
Other Study ID Numbers: EGF19060
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017

Keywords provided by GlaxoSmithKline:
tolerating lapatinib

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action