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

• Status: Completed
• Trial end date: 2008-01-09
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Lapatinib

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.