Spots Global Cancer Trial Database for An International Phase 2 Study Of SU011248 In Patients With Advanced / Metastatic Gastric Cancer Failing Chemotherapy
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Trial Identification
Brief Title: An International Phase 2 Study Of SU011248 In Patients With Advanced / Metastatic Gastric Cancer Failing Chemotherapy
Official Title: An Open Label International Multi-Center Phase 2 Activity And Safety Study Of SU011248 In Patients With Advanced / Metastatic Gastric Cancer Progressing Or Recurring After One Prior Chemotherapy
Study ID: NCT00226811
Conditions
Interventions
Study Description
Brief Summary: The study consisted of two parts. In Part 1 the study enrolled 38 patients (Step 1 Simon 2 step design) after which Step 2 was opened and the total enrollment target for the study (n=63) was exceeded due to a rapid enrollment (78 patients were entered). Part 2 of the study did not open due to the final overall insufficiency of efficacy observed in 78 patients. Sunitinib (SU011248) was administered orally daily for 4 weeks followed by a 2-week rest at a starting dose of 50 mg with provision for dose reduction based on tolerability. All patients received repeated cycles of sunitinib until disease progression, occurrence of unacceptable toxicity, or other withdrawal criteria were met. After discontinuation of treatment, patients were followed up in order to collect information on further antineoplastic therapy and survival.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Pfizer Investigational Site, Nanjing, Jiangsu, China
Pfizer Investigational Site, Beijing, , China
Pfizer Investigational Site, Beijing, , China
Pfizer Investigational Site, Guangzhou, , China
Pfizer Investigational Site, Hong Kong, , Hong Kong
Pfizer Investigational Site, Shatin, , Hong Kong
Pfizer Investigational Site, Ancona, , Italy
Pfizer Investigational Site, Genova, , Italy
Pfizer Investigational Site, Kashiwa, Chiba, Japan
Pfizer Investigational Site, Suntougun, Shizuoka, Japan
Pfizer Investigational Site, Chuo-ku, Tokyo, Japan
Pfizer Investigational Site, Seoul, , Korea, Republic of
Pfizer Investigational Site, Seoul, , Korea, Republic of
Pfizer Investigational Site, Seoul, , Korea, Republic of
Pfizer Investigational Site, Seoul, , Korea, Republic of
Pfizer Investigational Site, Porto, , Portugal
Pfizer Investigational Site, Kwei-Shan, Taoyuan, Taiwan
Pfizer Investigational Site, Taipei, , Taiwan
Contact Details
Name: Pfizer CT.gov Call Center
Affiliation: Pfizer
Role: STUDY_DIRECTOR
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