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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT05067257
Recruitment Status : Suspended (Sorrento Therapeutics filed for chapter 11 bankruptcy.)
First Posted : October 5, 2021
Last Update Posted : April 28, 2023
Information provided by (Responsible Party):
Sorrento Therapeutics, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Pain, Intractable Pain Cancer Pain Drug: Resiniferatoxin Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Phase 2 Study to Assess the Safety and Efficacy of Epidural Resiniferatoxin for the Treatment of Intractable Pain Associated With Advanced Cancer
Estimated Study Start Date : September 2023
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : December 2024

Arm Intervention/treatment
Experimental: Resiniferatoxin
15 mcg, 20 mcg, or 25 mcg in 2mL injected once into the epidural space
Drug: Resiniferatoxin
Resiniferatoxin is a compound purified from natural sources
Other Name: RTX

Placebo Comparator: Placebo
2mL injected once into the epidural space
Drug: Placebo
Vehicle solution

No Intervention: Concurrent Control
No intervention

Primary Outcome Measures :
  1. Assess the incidence of any treatment-emergent adverse events of epidural Resiniferatoxin (RTX) [safety and tolerability] [ Time Frame: Baseline through study completion at up to approximately 12 months ]
    To assess the safety of epidural RTX including incidence and severity of any short-term and long-term treatment-emergent adverse events (TEAEs) using the Common Terminology Criteria for Adverse Events (CTCAE) criteria

Secondary Outcome Measures :
  1. Assess efficacy of RTX on pain associated with advanced cancer [ Time Frame: Baseline through study completion at up to approximately 12 months ]
    To assess efficacy of each epidural RTX dose in comparison to control groups on the subject's intractable pain due to advanced cancer using the Brief Pain Inventory, Short Form (BPI-SF) score (1-10, with 10 associated with worse pain)

  2. Assess RTX effect on quality of life [ Time Frame: Baseline through study completion at up to approximately 12 months ]
    To assess the efficacy of each epidural RTX dose in comparison to control groups on the quality of life using Treatment Helpfulness Questionnaire score (graded 1-7, with 7 being most helpful)

  3. Assess RTX effect on opioid consumption [ Time Frame: Baseline through study completion at up to approximately 12 months ]
    To assess the effect of each epidural RTX dose on opioid consumption, measuring the average reduction compared to baseline of daily opioid consumption, calculated as an oral morphine equivalent dose

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 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
  • Pregnant at Screening or planning on becoming pregnant or currently breastfeeding
  • Has an intrathecal shunt, increased intracranial pressure or evidence of brain pathology as determined by symptoms, history, physical examination, and/or magnetic resonance imaging (MRI)
  • Is unable or distinguish the target pain from any additional loci of pain at screening
  • Non-study related minor surgical procedure ≤ 2 days or major surgical procedure ≤ 7 days prior to screening and must be sufficiently recovered and stable prior to D1
  • Has not recovered from toxicities from previous cancer treatment, including chemotherapy, hormone therapy, immunotherapy, radiotherapy or bisphosphonates. Participants are not eligible if they have received such therapy within the month prior to D1
  • 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
  • Arterial thrombi, myocardial infarction, admission for unstable angina, within 3 months prior to screening
  • Clinically significant electrocardiogram abnormalities
  • Have any medical condition that could adversely impact subject's participation or safety or interfere with pain assessments
  • Participation in another investigational trial during the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT05067257

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United States, California
Altman Clinical and Translational Research Institute (ACTRI)
La Jolla, California, United States, 92037
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
United States, Texas
HD Research
Bellaire, Texas, United States, 77401
Sponsors and Collaborators
Sorrento Therapeutics, Inc.
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Study Director: Mike Royal, MD Sorrento Therapeutics, Inc.
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Responsible Party: Sorrento Therapeutics, Inc. Identifier: NCT05067257    
Other Study ID Numbers: RTX-CAP-201
First Posted: October 5, 2021    Key Record Dates
Last Update Posted: April 28, 2023
Last Verified: April 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sorrento Therapeutics, Inc.:
advanced cancer pain
cancer pain
Additional relevant MeSH terms:
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Pain, Intractable
Neurologic Manifestations