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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00087503 |
This will be an international, multicenter, uncontrolled, 2-stage, phase II study in adult patients with advanced gastric cancer, reasonable performance status, good organ function, lack of serious concomitant medical conditions. Patients must have progressed or recurred after a fluoropyrimidine-containing regimen at anytime for primary metastatic disease or within 6 months of last dose of adjuvant therapy. Twenty-one evaluable patients will be enrolled in Stage 1. If at least 2 objective tumor responses are observed in the first 21 evaluable patients, the study will be expanded to enroll a total of 41 evaluable patients. Edotecarin will be administered at a starting dose of 13 mg/m2 as an IV infusion over 60 minutes in repeated 3-week cycles treatment.
Condition | Intervention | Phase |
---|---|---|
Stomach Neoplasms |
Drug: Edotecarin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Efficacy And Safety Study Intravenous Edotecarin In Patients With Advanced Gastric Cancer That Has Progressed Or Recurred After Prior Fluropyrimidine-Based Chemotherapy |
Estimated Enrollment: | 28 |
Study Start Date: | April 2004 |
Study Completion Date: | June 2005 |
Primary Completion Date: | June 2005 (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:
Exclusion Criteria:
Belgium | |
Pfizer Investigational Site | |
Leuven, Belgium | |
Pfizer Investigational Site | |
Gent, Belgium | |
Pfizer Investigational Site | |
BRUXELLES, Belgium | |
France | |
Pfizer Investigational Site | |
Lille, France | |
Hong Kong | |
Pfizer Investigational Site | |
Unknown, Hong Kong | |
Spain | |
Pfizer Investigational Site | |
Barcelona, Spain | |
Pfizer Investigational Site | |
Madrid, Spain | |
Taiwan | |
Pfizer Investigational Site | |
Kwei-Shan, Taiwan | |
Pfizer Investigational Site | |
Kaohsiung, Taiwan | |
United Kingdom | |
Pfizer Investigational Site | |
Birmingham, United Kingdom |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Study ID Numbers: | EDOAGA-6736-001, A5921008 |
Study First Received: | July 9, 2004 |
Last Updated: | March 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00087503 |
Health Authority: | United States: Food and Drug Administration |
Stomach Diseases Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases |
Stomach Neoplasms Gastrointestinal Neoplasms Stomach cancer |
Neoplasms Neoplasms by Site |