NCT05067257

Study to Assess Epidural Resiniferatoxin for the Treatment of Intractable Pain Associated With Advanced Cancer

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Sorrento Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pain, Intractable
• Pain Cancer
• Pain

Interventions

Type	Name	Description
DRUG	Resiniferatoxin	Resiniferatoxin is a compound purified from natural sources
DRUG	Placebo	Vehicle solution

Timeline

• Start date: 2025-09-01
• Primary completion: 2027-06-01
• Completion: 2027-12-01
• First posted: 2021-10-05
• Last updated: 2024-03-18

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study