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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
July 28, 2006
August 1, 2006
November 10, 2017
June 29, 2004
January 9, 2008   (Final data collection date for primary outcome measure)
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
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.
Complete list of historical versions of study NCT00359190 on ClinicalTrials.gov Archive Site
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
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.
Not Provided
Not Provided
 
Pharmacokinetics And Pharmacodynamics Of Lapatinib In Two Dosing Regimens In Treatment-naive Patients With Breast Cancer
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
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Neoplasms, Breast
Drug: lapatinib
GW572016 ditosylate salt (lapatinib) will be given as 250 mg tablets via oral route
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..
Intervention: Drug: lapatinib
Spector NL, Robertson FC, Bacus S, Blackwell K, Smith DA, Glenn K, Cartee L, Harris J, Kimbrough CL, Gittelman M, Avisar E, Beitsch P, Koch KM. Lapatinib Plasma and Tumor Concentrations and Effects on HER Receptor Phosphorylation in Tumor. PLoS One. 2015 Nov 16;10(11):e0142845. doi: 10.1371/journal.pone.0142845. eCollection 2015.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
January 9, 2008
January 9, 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Israel,   United States
 
 
NCT00359190
EGF10027
No
Not Provided
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP