Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2025-12-27 @ 9:02 AM
Study NCT ID:
NCT00165594
Status:
TERMINATED
Last Update Posted:
2014-01-23
First Post:
2005-09-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of E7070 in Patients With Gastric Cancer
Sponsor:
Eisai Co., Ltd.
Organization:
Study Overview
Official Title:
Non-Randomized, Open, Uncontrolled, Dose Comparison Study of E7070 in Patients With Gastric Cancer
Status:
TERMINATED
Status Verified Date:
2014-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was completed.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: