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

Status
Temporarily Closed
Cancer Type
Solid Tumor
Unknown Primary
Trial Phase
Phase II
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT05067257
Protocol IDs
RTX-CAP-201 (primary)
NCI-2022-04731
Study Sponsor
Sorrento Therapeutics, Inc.

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.

Objectives

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

  1. Histologically or cytologically confirmed advanced cancer
  2. Targeted pain area of involvement that is at or below the lower thoracic or chest level down to lower extremities, attributed to the cancer
  3. If pain is present in other areas, able to differentiate pain in the target area is the primary source of pain
  4. Intractable pain that has not responded to standard therapies
  5. 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
  6. Have a Karnofsky Performance Scale score = 50 at Screening
  7. In the Investigator's opinion, a reasonable expectation that the subject will be able to complete the study
  8. Able to comply with the study procedures and give informed consent
  9. Willing to follow contraception guidelines

Treatment Sites in Georgia

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.