Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00127517
Status:
TERMINATED
Last Update Posted:
2011-06-08
First Post:
2005-08-05
Brief Title:
Palliative Care Study in Patients With Advanced Cancer
Sponsor:
Advanced Viral Research Corp
Organization:
Advanced Viral Research Corp
Study Overview
Official Title:
A Phase II Double Blind Placebo Controlled Randomized Multicenter Study With AVR118 Solution in Patients With Advanced Malignancies Who Are Not Candidates for Curative Chemotherapy
Status:
TERMINATED
Status Verified Date:
2011-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Company shifted focus
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether patients with advanced cancers who receive AVR118 solution for injection into the skin can achieve improvement in quality of life Based on a study in patients with AIDS possible benefits may include improved appetite and strength weight gain improved mood and decreased fatigue For the first three weeks some patients receive AVR118 and others receive placebo an injection expected to have no benefits After three weeks all patients will be offered the opportunity to take injections of AVR118
Detailed Description:
Advanced cancers are usually debilitating There are few treatments available for symptoms of advanced cancers like loss of appetite decreased strength fatigue and change in mood A Phase II double blind study comparing treatment with AVR118 to placebo followed by an open label phase treating all patients with AVR118 will enable the Sponsor to gather data on safety and efficacy of AVR118 in this patient population Patients aged 18-80 with advanced cancers excluding central nervous system CNS cancers who are not receiving chemotherapy or who are receiving single agent third line or beyond chemotherapy may be eligible to participate
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