NCT04572776

Phase 3 Study to Assess Resiniferatoxin vs Standard of Care for the Treatment of Intractable Cancer Pain

A Multicenter, Randomized, 2-Arm, Phase 3 Study to Assess the Efficacy and Safety of a Single Epidural Administration of Resiniferatoxin Versus Standard of Care (SoC) for the Treatment of Intractable Pain Associated With Cancer

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Sorrento Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 3 study to assess the safety and efficacy of a single epidural administration of Resiniferatoxin versus standard of care for the treatment of intractable pain associated with cancer.

Detailed description

This study is a multicenter, randomized Phase 3 study to assess the safety and efficacy of a single epidural administration of Resiniferatoxin versus standard of care (SOC) for the treatment of intractable pain associated with cancer. Subjects will be followed for 12 weeks after treatment.

Conditions

• Pain, Intractable
• Pain Cancer

Interventions

Type	Name	Description
DRUG	Resiniferatoxin	Resiniferatoxin is a TRPV-1 agonist which works by specifically ablating nociceptive nerve fibers.
OTHER	Standard of Care	Standard of care for intractable pain with the exception of intra-thecal pump placement as determined by the investigator.

Timeline

• Start date: 2020-12-01
• Primary completion: 2023-03-01
• Completion: 2023-03-01
• First posted: 2020-10-01
• Last updated: 2021-11-09

Regulatory

• FDA-regulated drug study