Pain, IntractablePhase 2NCT05067257
Study to Assess Epidural Resiniferatoxin for the Treatment of Intractable Pain Associated With Advanced Cancer
A Phase 2 study testing Resiniferatoxin in people with Pain, Intractable and Pain Cancer, run by Sorrento Therapeutics, Inc. at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Intractable, Pain Cancer, Pain
- What is being tested?
- Resiniferatoxin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 4 sitesUnited States
- Study dates
- Sep 2025to Dec 2027
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
HD Research
Bellaire, Texas, 77401
University of Florida
Gainesville, Florida, 32610
Altman Clinical and Translational Research Institute (ACTRI)
La Jolla, California, 92037
Oregon Health & Science University
Portland, Oregon, 97239
About this study
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
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.
Read the 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.
- Conditions
- Pain, Intractable, Pain Cancer, Pain
- Being tested
- Resiniferatoxin, Placebo
- Keywords
- advanced cancer pain, cancer pain, pain, resiniferatoxin, RTX
- Medical subject headings
- Pain, Intractable, Cancer Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ResiniferatoxinDrug
Also called RTX
Resiniferatoxin is a compound purified from natural sources
PlaceboDrug
Vehicle solution
| Study group | Role | What they receive |
|---|---|---|
| Resiniferatoxin | Experimental | 15 mcg, 20 mcg, or 25 mcg in 2mL injected once into the epidural space Receives: Drug: Resiniferatoxin |
| Placebo | Placebo comparator | 2mL injected once into the epidural space Receives: Drug: Placebo |
| Concurrent Control | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the incidence of any treatment-emergent adverse events of epidural Resiniferatoxin (RTX) [safety and tolerability]
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
Measured: Baseline through study completion at up to approximately 12 months
Secondary outcomes (3)
Assess efficacy of RTX on pain associated with advanced cancer
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)
Measured: Baseline through study completion at up to approximately 12 months
Assess RTX effect on quality of life
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)
Measured: Baseline through study completion at up to approximately 12 months
Assess RTX effect on opioid consumption
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
Measured: Baseline through study completion at up to approximately 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2021
- Study startSep 2025 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Why it stopped: Sorrento Therapeutics filed for chapter 11 bankruptcy.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, IntractableStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sorrento Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mike Royal, MD, Study director, Sorrento Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05067257
- Sponsor's protocol ID
- RTX-CAP-201
- Status last verified
- Mar 2024
- First submitted
- 17 Sep 2021
- Last updated
- 18 Mar 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05067257
- Acronym / sponsor ID
- RTX-CAP-201
- Conditions
- Pain, Intractable, Pain Cancer, Pain
- Keywords
- advanced cancer pain, cancer pain, pain, resiniferatoxin, RTX
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Sorrento Therapeutics filed for chapter 11 bankruptcy.
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Sorrento Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2025 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 5 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Resiniferatoxin | Experimental | Drug: Resiniferatoxin15 mcg, 20 mcg, or 25 mcg in 2mL injected once into the epidural space |
| Placebo | Placebo comparator | Drug: Placebo2mL injected once into the epidural space |
| Concurrent Control | No intervention | –No intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ResiniferatoxinAlso: RTXResiniferatoxin is a compound purified from natural sources | Drug | Resiniferatoxin |
| PlaceboVehicle solution | Drug | Placebo |
Primary outcome
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
3 secondary outcomes
Assess efficacy of RTX on pain associated with advanced cancer
Time frame: Baseline through study completion at up to approximately 12 months
Assess RTX effect on quality of life
Time frame: Baseline through study completion at up to approximately 12 months
Assess RTX effect on opioid consumption
Time frame: Baseline through study completion at up to approximately 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mike Royal, MD study director
Sorrento Therapeutics, Inc.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Resiniferatoxin in people with Pain, Intractable and Pain Cancer, run by Sorrento Therapeutics, Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2024.