Clinical trial NCT00359190: Pharmacokinetics And Pharmacodynamics Of Lapatinib In Two Dosing Regimens In Treatment-naive Patients With Breast Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasms, Breast
Keywords: lapatinib
breast cancer
treatment-naive
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-08-01
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
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.
timeFrame: subjects on study up to 15 days
Secondary outcomes:
measure: 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
Other outcomes:
Locations:
city: Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: Durham
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Allentown
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Nashville
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Dallas
country: United States
facility: GSK Investigational Site
state: Texas
city: Roanoke
country: United States
facility: GSK Investigational Site
state: Virginia
city: Milwaukee
country: United States
facility: GSK Investigational Site
state: Wisconsin
city: Ramat Gan
country: Israel
facility: GSK Investigational Site
city: Zrifin
country: Israel
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.