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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.
 
ClinicalTrials.gov Identifier: NCT05067257
Recruitment Status : Suspended (Sorrento Therapeutics filed for chapter 11 bankruptcy.)
First Posted : October 5, 2021
Last Update Posted : April 28, 2023
Sponsor:
Information provided by (Responsible Party):
Sorrento Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE September 17, 2021
First Posted Date  ICMJE October 5, 2021
Last Update Posted Date April 28, 2023
Estimated Study Start Date  ICMJE September 2023
Estimated Primary Completion Date June 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 3, 2021)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 3, 2021)
  • 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)
  • 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)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Assess Epidural Resiniferatoxin for the Treatment of Intractable Pain Associated With Advanced Cancer
Official Title  ICMJE A Multicenter, Phase 2 Study to Assess the Safety and Efficacy of Epidural Resiniferatoxin for the Treatment of Intractable Pain Associated With Advanced Cancer
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Pain, Intractable
  • Pain Cancer
  • Pain
Intervention  ICMJE
  • Drug: Resiniferatoxin
    Resiniferatoxin is a compound purified from natural sources
    Other Name: RTX
  • Drug: Placebo
    Vehicle solution
Study Arms  ICMJE
  • Experimental: Resiniferatoxin
    15 mcg, 20 mcg, or 25 mcg in 2mL injected once into the epidural space
    Intervention: Drug: Resiniferatoxin
  • Placebo Comparator: Placebo
    2mL injected once into the epidural space
    Intervention: Drug: Placebo
  • No Intervention: Concurrent Control
    No intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: October 3, 2021)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2024
Estimated Primary Completion Date June 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05067257
Other Study ID Numbers  ICMJE RTX-CAP-201
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Sorrento Therapeutics, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Sorrento Therapeutics, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Mike Royal, MD Sorrento Therapeutics, Inc.
PRS Account Sorrento Therapeutics, Inc.
Verification Date April 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP