Gastric Cancer Clinical Trial
Official title:
Non-Randomized, Open, Uncontrolled, Dose Comparison Study of E7070 in Patients With Gastric Cancer
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.
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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