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SUSPENDEDPHASE2

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

NCT05067257•Sorrento Therapeutics, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
•Non-study related minor surgical procedure ≤ 5 days or major surgical procedure ≤ 21 days prior to enrollment. In all cases, subjects must be sufficiently recovered and stable prior to IP administration on D1
+4 more criteria

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 coagulopathy or hemostasis problem including a low platelet count, prothrombin time, abnormal PT or PTT, or on anticoagulant or antiplatelet therapies before and during investigational product (IP) administration
•Have evidence or history of bleeding disorder or disseminated intravascular coagulation, any recent hemorrhage or bleeding event within 4 weeks prior to D1
•Have abnormal neutrophil or serum creatinine
•Is febrile or has other evidence of infection within 24 hours of D1
•Has recently been diagnosed as COVID-19 positive or evidence of active infection. The subject may participate if full recovery has occurred with a negative RT-PCR test (any EUA cleared test) at least 1 week prior to D1
•Has an allergy or hypersensitivity to TRPV1 agonists, bupivacaine, radiographic contrast agents, fentanyl, hydromorphone, or morphine
+4 more criteria

Locations (4)

Altman Clinical and Translational Research Institute (ACTRI)

La Jolla, California, United States

University of Florida

Gainesville, Florida, United States

Oregon Health & Science University

Portland, Oregon, United States

HD Research

Bellaire, Texas, United States

Key Dates

Start Date

September 1, 2025

Primary Completion Date

June 1, 2027

Completion Date

December 1, 2027

Last Updated

March 18, 2024

Enrollment

120

ESTIMATED participants

Conditions

Pain, IntractablePain CancerPain

Interventions

Resiniferatoxin

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 18, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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