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

Completed · Phase 1

Conditions studied: Neoplasms, Breast

In brief

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.

Key facts

Study ID

NCT00359190

Run by

GlaxoSmithKline

People needed

28

Starts

2004-06-29

Expected to finish

2008-01-09

Last updated by the study team

2017-11-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• GSK Investigational Site — Miami, Florida, United States
• GSK Investigational Site — Durham, North Carolina, United States
• GSK Investigational Site — Allentown, Pennsylvania, United States
• GSK Investigational Site — Pittsburgh, Pennsylvania, United States
• GSK Investigational Site — Nashville, Tennessee, United States
• GSK Investigational Site — Dallas, Texas, United States
• GSK Investigational Site — Roanoke, Virginia, United States
• GSK Investigational Site — Milwaukee, Wisconsin, United States
• GSK Investigational Site — Ramat Gan, Israel
• GSK Investigational Site — Zrifin, Israel

Full record on ClinicalTrials.gov

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