Ignite Creation Date:
2025-12-24 @ 6:58 PM
Ignite Modification Date:
2025-12-29 @ 5:21 PM
Study NCT ID:
NCT05067257
Status:
SUSPENDED
Last Update Posted:
2024-03-18
First Post:
2021-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Assess Epidural Resiniferatoxin for the Treatment of Intractable Pain Associated With Advanced Cancer
Sponsor:
Sorrento Therapeutics, Inc.
Organization:
Study Overview
Official Title:
A Multicenter, Phase 2 Study to Assess the Safety and Efficacy of Epidural Resiniferatoxin for the Treatment of Intractable Pain Associated With Advanced Cancer
Status:
SUSPENDED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sorrento Therapeutics filed for chapter 11 bankruptcy.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This Phase 2 study assesses the safety and efficacy of a single injection of Resiniferatoxin versus placebo for the treatment of intractable advanced cancer pain.
Detailed Description:
This is a global multicenter, randomized Phase 2 study for subjects with advanced cancer experiencing intractable pain to assess the safety and efficacy of a single epidural injection of Resiniferatoxin versus vehicle control. Additional subjects who elect to not enroll but are willing to be followed will comprise a Concurrent Control Group. Subjects will be followed for twelve months.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: