Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00332280
Status:
TERMINATED
Last Update Posted:
2013-03-20
First Post:
2006-05-31
Brief Title:
Study to Evaluate the Clinical Benefit Response in Cancer Patients With Advanced Disease With AMT2003 Versus Placebo
Sponsor:
Auron Healthcare GmbH
Organization:
Auron Healthcare GmbH
Study Overview
Official Title:
A Prospective Randomised Multicenter Phase IIIII Clinical Trial to Evaluate the Clinical Benefit Response in Cancer Patients With Advanced Disease With AMT Versus Placebo
Status:
TERMINATED
Status Verified Date:
2013-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of efficacy Stopped at first interim evaluation point
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to evaluate the efficacy and the safety of AMT2003 in cancer patients with advanced disease
The primary evaluation criterion is clinical benefit response
The primary evaluation criterion is clinical benefit response
Detailed Description:
The study will include patients with a variety of solid tumors ie esophageal colon pancreatic bronchial gastric hepatocellular gall bladder prostate and gynaecological carcinomas
The clinical benefit response - CBR is an end point that provides a clinical measure for symptom improvement in patients The key evaluation parameters for CBR will be assessment of pain the ability to perform daily activities and weight change
The clinical benefit response - CBR is an end point that provides a clinical measure for symptom improvement in patients The key evaluation parameters for CBR will be assessment of pain the ability to perform daily activities and weight change
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 |
|---|---|---|---|
| LC003AURON2005 | None | None | None |