Ignite Creation Date:
2024-05-05 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00441870
Status:
COMPLETED
Last Update Posted:
2012-03-09
First Post:
2007-02-27
Brief Title:
Study of EC0225 for the Treatment of Refractory or Metastatic Tumors
Sponsor:
Endocyte
Organization:
Endocyte
Study Overview
Official Title:
Protocol EC-0225-01 A Phase 1 Study of EC0225 Administered Weeks 1 and 3 of a 4-Week Cycle
Status:
COMPLETED
Status Verified Date:
2012-03
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 is a Phase 1 clinical trial evaluating the safety and tolerability of escalating doses of EC0225 in patients with refractory or metastatic tumors who have exhausted standard therapeutic options
Detailed Description:
This is a Phase 1 dose escalation study of EC0225 administered by intravenous bolus IV during weeks 1 and 3 of a 4-week cycle to patients with refractory or metastatic cancer who have exhausted standard therapeutic options EC0225 is a drug that is specifically designed to enter cells via a folate vitamin receptor Experimental evidence shows that the target receptor is over-expressed in many human cancers There are no previous human studies of EC0225 however lab research research in test tubes or animals using EC0225 has shown activity against tumors in animals This activity in animal models suggests that EC0225 may be useful as chemotherapy against human cancers The primary objective of this study is to determine the safety and maximum tolerated dose of EC0225 given by intravenous bolus The efficacy of treatment will also be measured
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