- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05067257
Study to Assess Epidural Resiniferatoxin for the Treatment of Intractable Pain Associated With Advanced Cancer
March 14, 2024 updated by: Sorrento Therapeutics, Inc.
A Multicenter, Phase 2 Study to Assess the Safety and Efficacy of Epidural Resiniferatoxin for the Treatment of Intractable Pain Associated With Advanced Cancer
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.
Study Overview
Status
Suspended
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Estimated)
120
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mike Royal, MD
- Phone Number: 4146 8582034100
- Email: mroyal@sorrentotherapeutics.com
Study Locations
-
-
California
-
La Jolla, California, United States, 92037
- Altman Clinical and Translational Research Institute (ACTRI)
-
-
Florida
-
Gainesville, Florida, United States, 32610
- University of Florida
-
-
Oregon
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Portland, Oregon, United States, 97239
- Oregon Health & Science University
-
-
Texas
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Bellaire, Texas, United States, 77401
- HD Research
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Resiniferatoxin
15 mcg, 20 mcg, or 25 mcg in 2mL injected once into the epidural space
|
Resiniferatoxin is a compound purified from natural sources
Other Names:
|
Placebo Comparator: Placebo
2mL injected once into the epidural space
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Vehicle solution
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No Intervention: Concurrent Control
No intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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Baseline through study completion at up to approximately 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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Baseline through study completion at up to approximately 12 months
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Assess RTX effect on quality of life
Time Frame: Baseline through study completion at up to approximately 12 months
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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)
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Baseline through study completion at up to approximately 12 months
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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
|
Baseline through study completion at up to approximately 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Mike Royal, MD, Sorrento Therapeutics, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
September 1, 2025
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
December 1, 2027
Study Registration Dates
First Submitted
September 17, 2021
First Submitted That Met QC Criteria
October 3, 2021
First Posted (Actual)
October 5, 2021
Study Record Updates
Last Update Posted (Actual)
March 18, 2024
Last Update Submitted That Met QC Criteria
March 14, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RTX-CAP-201
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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