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Sponsored by: |
Fudan University |
---|---|
Information provided by: | Fudan University |
ClinicalTrials.gov Identifier: | NCT00595985 |
The purpose of this study is to evaluate the efficacy and tolerability of sorafenib as second line treatment in patients with A/MGC
Condition | Intervention | Phase |
---|---|---|
Gastric Cancer |
Drug: sorafenib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | Phase II Trial of Sorafenib as Second Line Therapy in Patients With Advanced or Metastatic Gastric Cancer |
Estimated Enrollment: | 20 |
Study Start Date: | July 2007 |
Estimated Study Completion Date: | July 2009 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Experimental
administer sorafenib 400mg bid
|
Drug: sorafenib
sorafenib 400mg bid, and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
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Up to now, although FU based, cisplatin based and taxane based regimen, and ECF regimen have been suggested as the first line therapy for A/MGC by FDA, there is no standard regimen for patients with A/MGC as second line treatment. Based on the promising results of sorafenib in primary hepatic carcinoma and renal cancer, we design this clinical trial to evaluate the efficacy, time to progression and overall survival of sorafenib for A/MGC patients as a second line treatment.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: xiaodong zhu, M.D. | 862164175590 ext 1105 | xddr001@163.com |
China | |
Fudan University Cancer Hospital | Recruiting |
ShangHai, China, 200032 | |
Contact: xiaodong zhu, M.D. 862164175590 ext 1105 xddr001@163.com | |
Sub-Investigator: xiaodong zhu, M.D. |
Principal Investigator: | Jin Li, PhD, M.D. | Fudan University Cancer Hospital |
Responsible Party: | Department of medical oncology, Cancer Hospital, Fuandan University ( Base for drug clinical trials, Fudan University cancer hospital ) |
Study ID Numbers: | Sorafenib-MGC |
Study First Received: | January 7, 2008 |
Last Updated: | February 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00595985 |
Health Authority: | China: Ethics Committee |
Time to Progression Toxicity Overall survival |
Response rate Quality of live Toxicities |
Stomach Diseases Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Stomach Neoplasms |
Disease Progression Gastrointestinal Neoplasms Stomach cancer Sorafenib |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |