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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00536809 |
The purpose of this study is to determine the highest, tolerated dose level and safety of lapatinib, capecitabine and oxaliplatin in subjects with advanced cancer and to determine the clinical activity of the combination of drugs in subjects with previously untreated advanced or metastatic colorectal cancer.
Condition | Intervention | Phase |
---|---|---|
Advanced Colorectal Cancer Metastatic Colorectal Cancer Responsive to Fluoropyrimidines |
Drug: lapatinib Drug: oxaliplatin Drug: capecitabine |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase I Study of Lapatinib in Combination With Oxaliplatin and Capecitabine in Subjects With Advanced or Metastatic Colorectal Cancer |
Estimated Enrollment: | 50 |
Study Start Date: | September 2007 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | December 2008 (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:
Is considered post-menopausal (defined as amenorrheic for at least 1 year).
Specific to Part 1:
Exclusion criteria:
Contact: US GSK Clinical Trials Call Center | 877-379-3718 |
United States, Wisconsin | |
GSK Investigational Site | Recruiting |
Madison, Wisconsin, United States, 53792 |
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | EGF108991 |
Study First Received: | September 27, 2007 |
Last Updated: | October 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00536809 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Advanced Colorectal Cancer Metastatic Colorectal Cancer lapatinib |
oxaliplatin fluoropyrimidines cancers capecitabine |
Antimetabolites Capecitabine Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases Lapatinib Intestinal Diseases |
Protein Kinase Inhibitors Rectal Diseases Intestinal Neoplasms Oxaliplatin Digestive System Diseases Gastrointestinal Neoplasms Colorectal Neoplasms |
Antimetabolites Capecitabine Antimetabolites, Antineoplastic Digestive System Neoplasms Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Gastrointestinal Diseases Colonic Diseases Enzyme Inhibitors Lapatinib Intestinal Diseases |
Protein Kinase Inhibitors Rectal Diseases Pharmacologic Actions Intestinal Neoplasms Neoplasms Oxaliplatin Neoplasms by Site Digestive System Diseases Therapeutic Uses Gastrointestinal Neoplasms Colorectal Neoplasms |