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 range18 Years
SexALL
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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…
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