Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00165594
Status:
TERMINATED
Last Update Posted:
2014-01-23
First Post:
2005-09-12
Brief Title:
A Study of E7070 in Patients With Gastric Cancer
Sponsor:
Eisai Co Ltd
Organization:
Eisai Inc
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 EMIM 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 EMIM 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 EMIM 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 EMIM type by intravenously administering once every 3 weeks
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None