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

Recruiting in Palo Alto (17 mi)

+3 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Sorrento Therapeutics, Inc.

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing a single injection of Resiniferatoxin to help reduce severe pain in patients with advanced cancer. The treatment works by turning off the nerves that send pain signals to the brain. The study will compare the effects of this injection and follow patients for a year. Resiniferatoxin has been tested for urinary incontinence and overactive bladder, showing some effectiveness in reducing symptoms.

Research Team

Mike Royal, MD

Principal Investigator

Sorrento Therapeutics, Inc.

Eligibility Criteria

Inclusion Criteria

Histologically or cytologically confirmed advanced cancer

You have severe pain that hasn't gotten better with usual treatments.

Be opioid tolerant, defined as an average daily opioid consumption > 30 mg oral morphine equivalent dose during the screening and which has been stable for the month prior to screening

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Exclusion Criteria

Be undergoing or have plans to undergo changes to current cancer treatment from D-7 through M3

Had an implantation of intrathecal pump or spinal cord stimulator less than 6 weeks prior to D1 or planning to undergo such a placement during the study prior to M3

Unless approachable via the caudal route, have the level of intended epidural injection within site of prior lumbar spine surgical procedures that could disrupt the epidural space or otherwise impair ability of the injection to reach nerves

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