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Sponsored by: |
Eisai Limited |
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Information provided by: | Eisai Medical Research Inc. |
ClinicalTrials.gov Identifier: | NCT00165594 |
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.
Condition | Intervention | Phase |
---|---|---|
Gastric Cancer |
Drug: E7070 |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | Non-Randomized, Open, Uncontrolled, Dose Comparison Study of E7070 in Patients With Gastric Cancer |
Estimated Enrollment: | 50 |
Study Start Date: | February 2005 |
Ages Eligible for Study: | 20 Years to 74 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria (Phase I):
Patients with well-maintained functions of major organs (bone marrow, liver, kidney, and lung).
Patients who have no carry-over adverse drug reaction(s) that affect the evaluation of previous treatments and safety of E7070 after the completion of the previous treatment. Required periods of wash-out from the end of previous treatment to the beginning of the study treatment are as follows:
Exclusion Criteria (Phase I):
Patients who meet any of the following serious complications:
Patients who meet any of the following items regarding prolonged QT/QTc intervals:
Inclusion Criteria (Phase IIa):
Patients with well-maintained functions of major organs (bone marrow, liver, kidney, and lung).
Patients who have no carry-over adverse drug reaction(s) that affect the evaluation of previous treatment and safety of E7070 after the completion of the previous treatment. Required periods of wash-out from the end of previous treatment to the beginning of study treatment are as follows.
Exclusion Criteria (Phase IIa):
Patients with severe peritoneal dissemination that meet any of the following items.
Patients who meet any of the following serious complications:
Patients who meet any of the following items regarding prolonged QT/QTc intervals.
Japan, Chiba-prefecture | |
Kashiwa, Chiba-prefecture, Japan, 277-0882 | |
Japan, Kanagawa | |
Sagamihara-shi, Kanagawa, Japan | |
Japan, Osaka | |
Takatsuki-shi, Osaka, Japan | |
Japan, Shizuoka-prefecture | |
Sunto-gun, Shizuoka-prefecture, Japan, 411-0934 | |
Japan, Tokyo | |
Chuo-ku, Tokyo, Japan, 104-0045 |
Study Director: | Tatsuo Watanabe | Eisai Co., Ltd - Development Clinical Research Department. Clinical Research Center |
Study ID Numbers: | E7070-J081-217 |
Study First Received: | September 12, 2005 |
Last Updated: | March 9, 2007 |
ClinicalTrials.gov Identifier: | NCT00165594 History of Changes |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
gastric cancer Phase I Phase IIa E7070 |
Indisulam Pharmakogenomic 2C19 |
Stomach Diseases Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases |
Stomach Neoplasms Gastrointestinal Neoplasms Stomach Cancer |
Neoplasms Stomach Diseases Digestive System Diseases Neoplasms by Site |
Digestive System Neoplasms Gastrointestinal Diseases Stomach Neoplasms Gastrointestinal Neoplasms |