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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00477464 |
This study is to evaluate the safety and efficacy of lapatinib taken together with capecitabine in Japanese patients. The study will proceed in two phases; the first phase(Part1) will lead to an evaluation of the mainly tolerability as well as PK parameters. If there are no major safety concerns in Part 1, the study will move into the second phase (Part 2) to further evaluate the safety and clinical activity.
Condition | Intervention | Phase |
---|---|---|
Metastatic Breast Cancer |
Drug: lapatinib oral tablets, capecitabine oral tablets |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Clinical Evaluation of Lapatinib Administered With Capecitabine in Japanese Patients With ErbB2 Overexpressing Advanced or Metastatic Breast Cancer |
Estimated Enrollment: | 50 |
Study Start Date: | June 2007 |
Estimated Study Completion Date: | March 2010 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 20 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Subjects must have refractory breast cancer defined as progression in the locally advanced or metastatic setting or relapse within 6 months of completing adjuvant therapy. Prior therapies must include, but are not limited to:
Adequate hematologic value, hepatic and renal function as defined below. Hematologic ANC (absolute neutrophil count) ≥1.5×109/L Hemoglobin ≥9 g/dL Platelets ≥100× 109/L Hepatic Serum bilirubin ≤1.5×ULN
3×ULN without liver metastases Renal Serum creatinine Creatinine clearance* ≤50 mL/min
Exclusion criteria:
Subjects meeting any of the following criteria must not be enrolled in the study:
Contact: US GSK Clinical Trials Call Center | 877-379-3718 |
Japan | |
GSK Investigational Site | Recruiting |
Aichi, Japan, 464-8681 | |
GSK Investigational Site | Recruiting |
Tokyo, Japan, 113-8677 | |
GSK Investigational Site | Recruiting |
Tokyo, Japan, 135-8550 | |
GSK Investigational Site | Recruiting |
Tochigi, Japan, 329-0498 | |
GSK Investigational Site | Recruiting |
Kagoshima, Japan, 892-0833 | |
GSK Investigational Site | Withdrawn |
Hokkaido, Japan, 060-8648 | |
GSK Investigational Site | Recruiting |
Tokyo, Japan, 104-8560 | |
GSK Investigational Site | Recruiting |
Chiba, Japan, 277-8577 | |
GSK Investigational Site | Recruiting |
Osaka, Japan, 540-0006 | |
GSK Investigational Site | Recruiting |
Ibaraki, Japan, 305-8576 | |
GSK Investigational Site | Recruiting |
Shizuoka, Japan, 411-8777 | |
GSK Investigational Site | Recruiting |
Fukuoka, Japan, 811-1395 | |
GSK Investigational Site | Recruiting |
Hokkaido, Japan, 003-0804 | |
GSK Investigational Site | Recruiting |
Ehime, Japan, 791-0280 | |
GSK Investigational Site | Recruiting |
Osaka, Japan, 553-0003 | |
GSK Investigational Site | Recruiting |
Tokyo, Japan, 104-0045 |
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 109749 |
Study First Received: | May 22, 2007 |
Last Updated: | December 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00477464 |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
ErbB2-overexpressing, advanced/metastatic breast cancer, Lapatinib, GW572016, EGFR/ErbB1, |
HER-2/new, dual kinase inhibitor, pharmacokinetics |
Capecitabine Skin Diseases Fluorouracil |
Breast Neoplasms Lapatinib Breast Diseases |
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors |
Immunosuppressive Agents Protein Kinase Inhibitors Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses |