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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00044343 |
The purpose of this study is to determine the efficacy of an oral investigational drug in patients with refractory metastatic colorectal cancer after receiving prior therapy with 5-fluorouracil in combination with irinotecan and/or oxaliplatin.
Condition | Intervention | Phase |
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Colorectal Cancer |
Drug: lapatinib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Open-Label, Multicenter, Phase II Study of Oral Lapatinib (GW572016) as Single Agent, Second-Line Therapy in Subjects With Metastatic Colorectal Cancer Who Have Progressed on First-Line Therapy With 5-Fluorouracil in Combination With Irinotecan or Oxaliplatin |
Enrollment: | 80 |
Study Start Date: | September 2002 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | GSK Clinical Trial, MD | GlaxoSmithKline |
Study ID Numbers: | EGF20004 |
Study First Received: | August 26, 2002 |
Last Updated: | September 7, 2007 |
ClinicalTrials.gov Identifier: | NCT00044343 |
Health Authority: | United States: Food and Drug Administration |
colorectal cancer EGFR inhibitor lapatinib metastatic |
Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases Irinotecan Lapatinib Intestinal Diseases Rectal Diseases |
Intestinal Neoplasms Oxaliplatin Digestive System Diseases Fluorouracil Gastrointestinal Neoplasms Colorectal Neoplasms |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |