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

Neoplasms, Breast Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00359190
• Other study ID #: EGF10027
• Status: Completed
• Phase: Phase 1
• First received: July 28, 2006
• Last updated: November 8, 2017
• Start date: June 29, 2004
• Est. completion date: January 9, 2008

Study information

• Verified date: November 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: January 9, 2008
• Est. primary completion date: January 9, 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Neoplasms, Breast

Intervention

Drug:
• lapatinib
GW572016 ditosylate salt (lapatinib) will be given as 250 mg tablets via oral route

Locations

Country	Name	City	State
Israel	GSK Investigational Site	Ramat Gan
Israel	GSK Investigational Site	Zrifin
United States	GSK Investigational Site	Allentown	Pennsylvania
United States	GSK Investigational Site	Dallas	Texas
United States	GSK Investigational Site	Durham	North Carolina
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	Milwaukee	Wisconsin
United States	GSK Investigational Site	Nashville	Tennessee
United States	GSK Investigational Site	Pittsburgh	Pennsylvania
United States	GSK Investigational Site	Roanoke	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	biomarker analysis of tumor biopsies pre/post dose	subjects on study up to 15 days
Secondary	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.	safety assessments of labs, hematology labs, Electrocardiogram, vital signs	subjects on study up to 15 days

External Links

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