Last updated: 11/04/2018 06:32:25

Rollover Study Of Lapatinib In Cancer Patients

GSK study ID
EGF19060
See study documents
Clinicaltrials.gov ID
NCT00169533
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: An Open Label, Phase 1b Rollover Study to Assess the Long-Term Safety Profile of Lapatinib (GW572016) in Cancer Patients.
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

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:

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.

Interventions:
Drug: GW572016 oral tablets
Enrollment:
31
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Neoplasms, Breast
Product
lapatinib
Collaborators
Not applicable
Study date(s)
August 2004 to May 2009
Type
Interventional
Phase
1

Participation criteria

Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
  • 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
  • Permanent discontinuation of lapatinib in the previous study due to intolerance or
  • treatment failure.
Inclusion and exclusion 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.

Trial location(s)

Location
Status
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Location
GSK Investigational Site
Albuquerque, New Mexico, United States, 87131
Status
Terminated/Withdrawn
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Location
GSK Investigational Site
San Antonio, Texas, United States, 78229
Status
Terminated/Withdrawn
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Location
GSK Investigational Site
Edmonton, Alberta, Canada, T6G 1Z2
Status
Study Complete
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Location
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19111
Status
Terminated/Withdrawn
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Location
GSK Investigational Site
Detroit, Michigan, United States, 48201
Status
Terminated/Withdrawn
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Location
GSK Investigational Site
Cleveland, Ohio, United States, 44106
Status
Terminated/Withdrawn
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Location
GSK Investigational Site
Lebanon, New Hampshire, United States, 03756
Status
Study Complete
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Location
GSK Investigational Site
Indianapolis, Indiana, United States, 46202
Status
Terminated/Withdrawn
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Location
GSK Investigational Site
Chapel Hill, North Carolina, United States, 27599
Status
Study Complete
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Location
GSK Investigational Site
Tel Aviv, Israel, 64239
Status
Study Complete
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Location
GSK Investigational Site
Nashville, Tennessee, United States, 37203
Status
Terminated/Withdrawn
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Location
GSK Investigational Site
Durham, North Carolina, United States, 27705
Status
Terminated/Withdrawn
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Study documents

Clinical study report
Available language(s): English
Download document(s)
Scientific result summary
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2009-05-05

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

Participate in clinical trial
Additional information
Results for study EGF19060 can be found on the GSK Clinical Study Register.
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Access to clinical trial data by researchers
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