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Rollover Study Of Lapatinib In Cancer Patients

GlaxoSmithKline (GSK) logo

GlaxoSmithKline (GSK)

Status and phase

Completed
Phase 1

Conditions

Neoplasms, Breast

Treatments

Drug: GW572016 oral tablets

Study type

Interventional

Funder types

Industry

Identifiers

NCT00169533
EGF19060

Details and patient eligibility

About

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.

Enrollment

31 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

31 participants in 1 patient group

Arm 1
Experimental group
Description:
Lapatinib either 750, 1000, 1250 or 1500 mgs
Treatment:
Drug: GW572016 oral tablets

Trial contacts and locations

12

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Data sourced from clinicaltrials.gov

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