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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00105950 |
This study was designed to determine how effective and safe a new investigational drug, lapatinib, is in treating patients with treatment refractory or relapsed inflammatory breast cancer. Tumor tissue collected pre-treatment and at Day 28 will be examined for biologic activity by IHC (immunohistochemistry). Treatment will consist of daily oral therapy with lapatinib. A patient may continue treatment as long as they are receiving benefit. Blood samples for hematology and chemistry panels, MUGA/ECHO (multigated acquisition/echocardiogram) exams and physical exams will be performed throughout the study to monitor safety.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: lapatinib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Study to Evaluate the Efficacy, Safety and Pharmacodynamics of Lapatinib in Patients With Relapsed or Refractory Inflammatory Breast Cancer |
Estimated Enrollment: | 120 |
Study Start Date: | March 2005 |
Study Completion Date: | December 2007 |
Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
A female is eligible to enter and participate in the study if she is of:
Abstinence from sexual intercourse from 2 weeks prior to administration of the investigational product, throughout the active study treatment period, and through the post-treatment follow-up visit (to occur 28 days after last dose of investigational product).
Male partner who is sterile prior to the female subject's entry into the study and is the sole sexual partner for that female subject.
Implants of levonorgestrel. Injectable progestogen. Any intrauterine device (IUD) with a documented failure rate of less than 1% per year.
Oral contraceptives (either combined or progestogen only). Barrier methods including diaphragm or condom with a spermicide.
Exclusion criteria:
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | EGF103009 |
Study First Received: | March 18, 2005 |
Last Updated: | October 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00105950 |
Health Authority: | United States: Food and Drug Administration |
relapsed breast cancer refractory inflammatory breast cancer ErbB2 overexpressing ErbB1 expressing |
Inflammatory breast cancer Skin Diseases Breast Neoplasms Lapatinib Breast Diseases |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |