Ignite Creation Date:
2025-12-24 @ 2:45 PM
Ignite Modification Date:
2025-12-25 @ 6:15 PM
Study NCT ID:
NCT00949559
Status:
COMPLETED
Last Update Posted:
2012-04-04
First Post:
2009-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacodynamics (PD) and Pharmacokinetics (PK) Study of EP-100 in Advanced Solid Tumors
Sponsor:
Esperance Pharmaceuticals Inc
Organization:
Study Overview
Official Title:
A Phase 1, Multi-center, Open-label, Dose-escalation, Safety, Pharmacodynamic and Pharmacokinetic Study of EP-100 Given Intravenously 3 Out of 4 Weeks in Subjects With Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2012-04
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 study is being done to:
* Test the safety of EP-100 and see what effect (good and bad) it has on the patient and their cancer;
* Find the highest dose of EP-100 that can be given without causing bad side effects;
* Examine how much EP-100 is in the blood at certain times after it is given and how quickly the body gets rid of it;
* Observe whether there is any effect of EP-100 on the size and activity of cancer in the patient's body.
* Test the safety of EP-100 and see what effect (good and bad) it has on the patient and their cancer;
* Find the highest dose of EP-100 that can be given without causing bad side effects;
* Examine how much EP-100 is in the blood at certain times after it is given and how quickly the body gets rid of it;
* Observe whether there is any effect of EP-100 on the size and activity of cancer in the patient's body.
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?: