Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00087503
Status:
COMPLETED
Last Update Posted:
2008-04-01
First Post:
2004-07-09
Brief Title:
Intravenous Edotecarin in Patients With Advanced Gastric Cancer That Has Progressed or Recurred After Chemotherapy
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
A Phase II Efficacy And Safety Study Intravenous Edotecarin In Patients With Advanced Gastric Cancer That Has Progressed Or Recurred After Prior Fluropyrimidine-Based Chemotherapy
Status:
COMPLETED
Status Verified Date:
2008-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This will be an international multicenter uncontrolled 2-stage phase II study in adult patients with advanced gastric cancer reasonable performance status good organ function lack of serious concomitant medical conditions Patients must have progressed or recurred after a fluoropyrimidine-containing regimen at anytime for primary metastatic disease or within 6 months of last dose of adjuvant therapy Twenty-one evaluable patients will be enrolled in Stage 1 If at least 2 objective tumor responses are observed in the first 21 evaluable patients the study will be expanded to enroll a total of 41 evaluable patients Edotecarin will be administered at a starting dose of 13 mgm2 as an IV infusion over 60 minutes in repeated 3-week cycles treatment
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| A5921008 | None | None | None |