Study to Assess Epidural Resiniferatoxin for the Treatment of Intractable Pain Associated With Ad… (NCT05067257) | Clinical Trial Compass
SuspendedPhase 2
Study to Assess Epidural Resiniferatoxin for the Treatment of Intractable Pain Associated With Advanced Cancer
Stopped: Sorrento Therapeutics filed for chapter 11 bankruptcy.
United States120 participantsStarted 2025-09
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histologically or cytologically confirmed advanced cancer
* Targeted pain area of involvement that is at or below the lower thoracic or chest level down to lower extremities, attributed to the cancer
* If pain is present in other areas, able to differentiate pain in the target area is the primary source of pain
* Intractable pain that has not responded to standard therapies
* 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
* Have a Karnofsky Performance Scale score ≥ 50 at Screening
* In the Investigator's opinion, a reasonable expectation that the subject will be able to complete the study
* Able to comply with the study procedures and give informed consent
* Willing to follow contraception guidelines
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
* Have leptomeningeal metastases in the lumbar area
* 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
* Has evidence of a non-correctable coagulopat…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Assess the incidence of any treatment-emergent adverse events of epidural Resiniferatoxin (RTX) [safety and tolerability]
Timeframe: Baseline through study completion at up to approximately 12 months