Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
GlaxoSmithKline |
---|---|
Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00447226 |
This study will examine the efficacy and safety of lapatinib in patients with ErbB2 positive ovarian, gastric/esophageal adenocarcinoma, uterine serous papillary, or bladder cancers.
Condition | Intervention | Phase |
---|---|---|
Ovarian Cancer Esophageal and Gastric Varices Adenocarcinoma Uterine Cancer Bladder Cancer |
Drug: Oral lapatinib tablets or placebo tablets |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | A Phase II, Placebo Controlled, Double-Blind, Randomized, Discontinuation Study of Lapatinib Administered Orally to Subjects With ErbB2 Positive Ovarian, Gastric/Esophageal Adenocarcinoma, Uterine Serous Papillary, or Bladder Cancer |
Estimated Enrollment: | 250 |
Study Start Date: | January 2007 |
Estimated Study Completion Date: | October 2010 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Table 1 Baseline Laboratory Values
Hematologic:
ANC (absolute neutrophil count) >1.5 x 109/L hemoglobin >9 g/dL platelets >75 x 109/L
Hepatic:
albumin >2.5 g/dL serum bilirubin <1.25 x ULN AST / ALT <3 x ULN if no documented liver metastases AST / ALT <5 x ULN with documented liver metastases
Renal:
serum creatinine <2.0 mg/dL
Exclusion Criteria:
United States, Colorado | |
GSK Clinical Trials Call Center | |
Denver, Colorado, United States, 80218 | |
United States, Indiana | |
GSK Clinical Trials Call Center | |
Indianapolis, Indiana, United States, 46227 | |
United States, Kansas | |
GSK Clinical Trials Call Center | |
Overland Park, Kansas, United States, 66210 | |
United States, Minnesota | |
GSK Clinical Trials Call Center | |
Minneapolis, Minnesota, United States, 55404 | |
United States, Missouri | |
GSK Clinical Trials Call Center | |
St.Louis, Missouri, United States, 63141 | |
United States, Nevada | |
GSK Clinical Trials Call Center | |
Las Vegas, Nevada, United States, 89109 | |
United States, New York | |
GSK Clinical Trials Call Center | |
Albany, New York, United States, 12208 | |
United States, North Carolina | |
GSK Clinical Trials Call Center | |
Raleigh, North Carolina, United States, 27607 | |
United States, South Carolina | |
GSK Clinical Trials Call Center | |
Greenville, South Carolina, United States, 29615 | |
United States, Texas | |
GSK Clinical Trials Call Center | |
El Paso, Texas, United States, 79915 | |
GSK Clinical Trials Call Center | |
Bedford, Texas, United States, 76022 | |
GSK Clinical Trials Call Center | |
Dallas, Texas, United States, 75246 | |
GSK Clinical Trials Call Center | |
Austin, Texas, United States, 78731 | |
GSK Clinical Trials Call Center | |
Tyler, Texas, United States, 75702 | |
GSK Clinical Trials Call Center | |
Fort Worth, Texas, United States, 76104 | |
GSK Clinical Trials Call Center | |
Webster, Texas, United States, 77598-4420 | |
United States, Virginia | |
GSK Clinical Trials Call Center | |
Leesburg, Virginia, United States, 20176 | |
GSK Clinical Trials Call Center | |
NewPort News, Virginia, United States, 23606 | |
United States, Washington | |
GSK Clinical Trials Call Center | |
Spokane, Washington, United States, 99218 | |
GSK Clinical Trials Call Center | |
Vancouver, Washington, United States, 98684 |
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Study ID Numbers: | LPT108741 |
Study First Received: | March 13, 2007 |
Last Updated: | June 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00447226 |
Health Authority: | United States: Food and Drug Administration |
Lapatinib ErbB2 positive Ovarian Cancer |
Gastric/Esophageal Cancer Uterine Serous Papillary Cancer Bladder Cancer |
Liver Diseases Gonadal Disorders Gastrointestinal Diseases Esophageal Neoplasms Disease Progression Urogenital Neoplasms Hypertension, Portal Ovarian Diseases Urologic Neoplasms Portal hypertension Genital Diseases, Female Varicose Veins Urologic Diseases Uterine Neoplasms Esophageal neoplasm |
Bladder neoplasm Endocrine Gland Neoplasms Ovarian cancer Ovarian Neoplasms Cystocele Esophageal disorder Urinary Bladder Diseases Urinary Bladder Neoplasms Genital Neoplasms, Female Uterine Diseases Endocrine System Diseases Lapatinib Carcinoma Digestive System Diseases Esophageal and Gastric Varices |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions Adnexal Diseases |