Last updated: 11/04/2018 06:22:09

Pharmacokinetics And Pharmacodynamics Of Lapatinib In Two Dosing Regimens In Treatment-naive Patients With Breast Cancer

GSK study ID
EGF10027
See study documents
Clinicaltrials.gov ID
NCT00359190
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: A Phase I, Open Label Study of the Safety, Pharmacokinetics and Pharmacodynamics of GW572016 in Once Daily Versus Twice Daily Dosing Regimens in Patients with Treatment- Naive Breast Cancer
Trial description: This study will examine the inhibition of ErbB1 and ErbB2 phosphorylation and downstream mediators of tumor cell growth and survival tumor tissue in treatment-naive breast cancer patients for three dosing schedules of lapatinib.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Comparison of the effects of 3 dosing schedules of lapatinib on biomarkers involved in regulating tumor cell proliferation and survival in pre-treatment and post-treatment breast tumor tissue samples.

Timeframe: subjects on study up to 15 days

Secondary outcomes:

Evaluation of adverse events and changes in lab values from pre-dose and post-dose. Assessment of safety & tolerability of lapatinib at multiple doses when administered to patients who have not have not been treated for breast tumors.

Timeframe: subjects on study up to 15 days

Interventions:
Drug: lapatinib
Enrollment:
28
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)
June 2004 to January 2008
Type
Interventional
Phase
1

Participation criteria

Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
  • Clinical labs are within acceptable ranges.
  • A histologically confirmed, treatment-naive, breast tumor measuring 1 cm or greater that can be readily biopsied.
  • Female who is pregnant or lactating.
  • Medically unfit by the doctor as a result of the medical interview or physicals.
Inclusion and exclusion criteria
Inclusion criteria:
  • Clinical labs are within acceptable ranges.
  • A histologically confirmed, treatment-naive, breast tumor measuring 1 cm or greater that can be readily biopsied.
  • At least 18 years of age.
  • Females must meet certain criteria specified in protocol.
  • Ability to swallow and retain oral medication.
  • Ability to follow and understand directions.
Exclusion criteria:
  • Female who is pregnant or lactating.
  • Medically unfit by the doctor as a result of the medical interview or physicals.
  • Received treatment of an investigational drug within 4 weeks of study start.
  • Currently receiving treatment with prohibited meds listed in protocol.
  • Had major surgery in previous 2 weeks.
  • Had prior radiation therapy to the chest to treat this incidence of breast cancer.
  • Hypersensitivity reaction or idiosyncrasy to drugs chemically related to the study med.
  • Has a malabsorption syndrome.

Trial location(s)

Location
Status
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Location
GSK Investigational Site
Durham, North Carolina, United States, 27710
Status
Terminated/Withdrawn
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Location
GSK Investigational Site
Miami, Florida, United States, 33136-1002
Status
Terminated/Withdrawn
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Location
GSK Investigational Site
Zrifin, Israel, 70300
Status
Terminated/Withdrawn
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Location
GSK Investigational Site
Milwaukee, Wisconsin, United States, 53226
Status
Terminated/Withdrawn
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Location
GSK Investigational Site
Dallas, Texas, United States, 75235
Status
Terminated/Withdrawn
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Location
GSK Investigational Site
Nashville, Tennessee, United States, 37203
Status
Terminated/Withdrawn
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Location
GSK Investigational Site
Allentown, Pennsylvania, United States, 18104
Status
Terminated/Withdrawn
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Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15213
Status
Terminated/Withdrawn
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Location
GSK Investigational Site
Roanoke, Virginia, United States, 24018
Status
Terminated/Withdrawn
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Location
GSK Investigational Site
Ramat Gan, Israel, 52621
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
2008-09-01

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

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Additional information
Results for study EGF10027 can be found on the GSK Clinical Study Register.
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