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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00359190
First Posted: August 1, 2006
Last Update Posted: November 10, 2017
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.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose
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.

Condition Intervention Phase
Neoplasms, Breast Drug: lapatinib Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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. [ Time Frame: subjects on study up to 15 days ]
    biomarker analysis of tumor biopsies pre/post dose


Secondary Outcome Measures:
  • 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. [ Time Frame: subjects on study up to 15 days ]
    safety assessments of labs, hematology labs, Electrocardiogram, vital signs


Enrollment: 28
Actual Study Start Date: June 29, 2004
Study Completion Date: January 9, 2008
Primary Completion Date: January 9, 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lapatinib receivers
Subjects with treatment-naïve breast tumors will be administered lapatinib 1500 mg once daily, 1000 mg once daily, or 500 mg twice daily for a minimum of 9 days and maximum of 15 days prior to surgical resection..
Drug: lapatinib
GW572016 ditosylate salt (lapatinib) will be given as 250 mg tablets via oral route

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00359190


Locations
United States, Florida
GSK Investigational Site
Miami, Florida, United States, 33136-1002
United States, North Carolina
GSK Investigational Site
Durham, North Carolina, United States, 27710
United States, Pennsylvania
GSK Investigational Site
Allentown, Pennsylvania, United States, 18104
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
GSK Investigational Site
Nashville, Tennessee, United States, 37203
United States, Texas
GSK Investigational Site
Dallas, Texas, United States, 75235
United States, Virginia
GSK Investigational Site
Roanoke, Virginia, United States, 24018
United States, Wisconsin
GSK Investigational Site
Milwaukee, Wisconsin, United States, 53226
Israel
GSK Investigational Site
Ramat Gan, Israel, 52621
GSK Investigational Site
Zrifin, Israel, 70300
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00359190     History of Changes
Other Study ID Numbers: EGF10027
First Submitted: July 28, 2006
First Posted: August 1, 2006
Last Update Posted: November 10, 2017
Last Verified: November 2017

Keywords provided by GlaxoSmithKline:
lapatinib
breast cancer
treatment-naive

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