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Brief Title: A Study of E7070 in Patients With Gastric Cancer
Official Title: Non-Randomized, Open, Uncontrolled, Dose Comparison Study of E7070 in Patients With Gastric Cancer
Study ID: NCT00165594
Brief Summary: Phase I study: To investigate primary objective (maximal tolerated dose and dose-limiting toxicity) and secondary objectives (pharmacokinetics, safety, estimation of a recommended dose, and anti-tumor effect by evaluable case) of E7070 in patients with gastric cancer who are extensive or intermediate metabolizer type (EM/IM) to CYP2C9 and CYP2C9 by intravenously administering once every 3 weeks. Phase IIa study: To investigate primary objective (response rate for efficacy assessment) and secondary objectives (frequency and severity of adverse drug reactions, and pharmacokinetics) of E7070 in patient with gastric cancer who are EM/IM type by intravenously administering once every 3 weeks.
Detailed Description:
Minimum Age: 20 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
, Kashiwa, Chiba-prefecture, Japan
, Sagamihara-shi, Kanagawa, Japan
, Takatsuki-shi, Osaka, Japan
, Sunto-gun, Shizuoka-prefecture, Japan
, Chuo-ku, Tokyo, Japan
Name: Tatsuo Watanabe
Affiliation: Eisai Co., Ltd - Development Clinical Research Department. Clinical Research Center
Role: STUDY_DIRECTOR