Pain, IntractablePhase 3NCT04572776
Phase 3 Study to Assess Resiniferatoxin vs Standard of Care for the Treatment of Intractable Cancer Pain
A Phase 3 study testing Resiniferatoxin in people with Pain, Intractable and Pain Cancer, run by Sorrento Therapeutics, Inc..
Trial summary
This is a Phase 3 study to assess the safety and efficacy of a single epidural administration of Resiniferatoxin versus standard of care for the treatment of intractable pain associated with cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Intractable, Pain Cancer
- What is being tested?
- Resiniferatoxin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2020to Mar 2023
- Phase
- Phase 3
- 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 confirmed clinical diagnosis of advanced cancer or metastasis.
- Pain in the target area (lower thoracic or chest level down to lower extremities) most likely attributed to cancer as per Investigator.
- Pain severity at the target area is moderate-to-severe, defined as worst pain ≥6 on the NPRS during screening (average of the 3 days prior to Day 1), despite available pain therapy or analgesia. Subjects with multiple sites of pain are eligible as long as the intensity of pain at the intended target location for treatment fulfills the score of ≥6 and can be differentiated from other areas.
- Must report NPRS scores in the daily diary for at least 3 days prior to Day 1.
- Must be at least 18 years of age or older at Screening.
- Subject has reasonable expectation that they will be able to complete the study (through at least the week 4 visit).
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- Life expectancy of at least 6 months at screening
- Minimum Karnofsky score of 50 at screening
- Sexually active female participants of childbearing potential must be willing to use an effective method of contraceptive method to avoid pregnancy
- Must have provided written informed consent which includes signing the institutional review board approved consent form prior to participating in any study related activity.
- Must be willing and capable of understanding and cooperating with the requirements of the study, including the ability to perform/undergo all required assessments for the duration of the study.
- Must be able to understand, and complete study related forms and adequately communicate with the investigator and/or site staff.
Who cannot join
- Undergoing or have plans to undergo changes to current cancer treatment from 7 days prior to Day 1 to 4 weeks after Day 1. Continuation of existing anti-cancer therapy without any planned change in dose or regimen is permitted. Participants may receive new cancer therapy 4 weeks after Day 1 including investigational agents in another clinical trial while participating in this study. If participating in another trial, it is requested that the subject agree to continue clinic visits and completion of patient diaries in this trial.
- Participants with leptomeningeal metastases in the lumbar area.
- Level of intended epidural injection is in the site of prior lumbar spine surgical procedures, such as posterior spinal fusions, that could impair the ability to perform the injection, as assessed by the Investigator.
- Evidence of increased intracranial pressure as determined by symptoms, history, physical examination, and/or magnetic resonance imaging (MRI).
- Patients with an intra-thecal pump implanted within 2 weeks of the baseline visit will be excluded. Pump placement during the study will not be permitted for 4 weeks after the study drug is administered; and existing pump medications cannot be changed during that same initial 4 week period.
- Has evidence of a non-correctable coagulopathy or hemostasis problem at Screening (V1) or Baseline (V2) as defined by:
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- Prothrombin Time/International Normalized Ratio ≥1.3 times upper limit of normal (ULN) range with blood drawn within 1 week of the planned injection.
- Partial thromboplastin time ≥1.5times upper limit of normal (ULN) with blood drawn within 1 week of the planned injection.
- Platelet count <75,000 cells/mm3 with blood drawn within 1 week of the planned injection. Participants must stop any anticoagulant (e.g., warfarin) or antiplatelet (e.g., aspirin) before and during IP administration according to acceptable medical guidelines. Participants with abnormal PT or PTT at Screening, but whose PT or PTT is expected to normalize once anticoagulation is held, are eligible as long as the PT or PTT has normalized prior to the planned injection.
- Participants with a total neutrophil count <750 cells/mm3 at Screening (V1) or Baseline (V2).
- Is febrile or has other evidence of an infection within 24 hours of the planned injection.
- Has an allergy or hypersensitivity to capsaicin, or radiographic contrast agents used in diagnostic imaging studies.
- Female participants who are pregnant at Screening (V1) or Day 1 (V2), are planning on becoming pregnant, or are currently breastfeeding.
- Participants with any medical condition that, in the Investigator's opinion, could adversely impact study participation or safety, the conduct of the study, or interfere with the pain assessments.
- Participants with additional loci of pain above the midthoracic level or other pain disorder due to noncancer etiology at Screening (V1), unless both the investigator and the subject are clearly able to distinguish this pain from the target pain due to cancer.
- Non-study related minor surgical procedure ≤2 days or major surgical procedure ≤7 days prior to the Screening Visit. In all cases, the subject must be sufficiently recovered and stable prior to IP administration on D1.
- Participants who have not recovered from any toxicities from previous chemotherapy, hormone therapy, immunotherapy, or radiotherapies that are Grade 3 or higher by CTCAE. Participants are eligible if the toxicities are Grade 2 or less, as long as all other inclusion/exclusion criteria are fulfilled.
- Arterial thrombi (including stroke), myocardial infarction, admission for unstable angina, within 3 months prior to Screening (V1).
- Evidence or history of bleeding disorder, i.e., any hemorrhage or bleeding event of CTCAE >Grade 2 within 4 weeks prior to D1.
About this study
Official title: A Multicenter, Randomized, 2-Arm, Phase 3 Study to Assess the Efficacy and Safety of a Single Epidural Administration of Resiniferatoxin Versus Standard of Care (SoC) for the Treatment of Intractable Pain Associated With Cancer
This is a Phase 3 study to assess the safety and efficacy of a single epidural administration of Resiniferatoxin versus standard of care for the treatment of intractable pain associated with cancer.
Read the detailed description
This study is a multicenter, randomized Phase 3 study to assess the safety and efficacy of a single epidural administration of Resiniferatoxin versus standard of care (SOC) for the treatment of intractable pain associated with cancer. Subjects will be followed for 12 weeks after treatment.
- Conditions
- Pain, Intractable, Pain Cancer
- Being tested
- Resiniferatoxin, Standard of Care
- Keywords
- pain, cancer pain, intractable pain, RTX, resiniferatoxin
- 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 TRPV-1 agonist which works by specifically ablating nociceptive nerve fibers.
Standard of CareOther
Also called SOC
Standard of care for intractable pain with the exception of intra-thecal pump placement as determined by the investigator.
| Study group | Role | What they receive |
|---|---|---|
| Resiniferatoxin | Experimental | Single dose of Resiniferatoxin (25 mcg in 3 mL) injected epidurally Receives: Drug: Resiniferatoxin |
| Standard of Care | Active comparator | Standard of care treatment as determined by the investigator Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in worst pain as assessed using the Numeric Pain Rating Scale (NPRS)
Change from baseline to Week 4 in the intensity of worst pain over the previous 24 hours in the area targeted for treatment as measured by the 11-point NPRS (0-10 where 0 is no pain and 10 is worst pain imaginable)
Measured: Baseline to Week 4
Secondary outcomes (6)
Change in worst pain as assessed using the NPRS
Change from baseline to Weeks 8 and 12 in the intensity of worst pain over the previous 24 hours in the area targeted for treatment as measured by the 11-point NPRS (0-10 where 0 is no pain and 10 is worst pain imaginable)
Measured: Baseline to Weeks 8 and 12
Change in area under the curve (AUC) of worst pain as assessed using the NPRS
AUC calculated on change from baseline through Week 4 in worst pain in the target pain location over the previous 24 hours, using the NPRS (0-10)
Measured: Baseline through Week 4
Incidence and severity of adverse events (AEs)
Incidence and severity of AEs assessed using the Common Terminology Criteria for Adverse Events (CTCAE) criteria
Measured: Baseline through Week 12
Change in Quality of Life (QOL) as assessed using the modified Brief Pain Inventory-Short Form (BPI-SF)
Change in Quality of Life from baseline to week 4 based on total score from the BPI-SF, modified to record the target pain treated with study drug
Measured: Baseline to Week 4
Duration of response in subjects who experienced ≥20% decrease from baseline in worst pain as assessed using the NPRS
Duration of response defined as time from ≥20% decrease from baseline in worst pain score in the target pain location to ≥20% increase from the nadir of the worst pain score
Measured: Randomization through Week 12
Change in intensity of average pain as assessed using the NPRS
Change from baseline to Week 4 in the intensity of average pain over the previous 24 hours in the target pain location as measured by the NPRS (0-10)
Measured: Baseline to Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2020
- Study startDec 2020 (estimated)
- Primary completionMar 2023 (estimated)
- Study completionMar 2023 (estimated)
Why it stopped: To be replaced by a different protocol
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sorrento Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Monica Luchi, MD, Study director, Sorrento Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04572776
- Sponsor's protocol ID
- STI-RTX-300x
- Status last verified
- Nov 2021
- First submitted
- 29 Sep 2020
- Last updated
- 9 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, 2-Arm, Phase 3 Study to Assess the Efficacy and Safety of a Single Epidural Administration of Resiniferatoxin Versus Standard of Care (SoC) for the Treatment of Intractable Pain Associated With Cancer
- ClinicalTrials.gov ID
- NCT04572776
- Acronym / sponsor ID
- STI-RTX-300x
- Conditions
- Pain, Intractable, Pain Cancer
- Keywords
- pain, cancer pain, intractable pain, RTX, resiniferatoxin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: To be replaced by a different protocol
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sorrento Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2020 (estimated)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 1 Oct 2020 (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 is a Phase 3 study to assess the safety and efficacy of a single epidural administration of Resiniferatoxin versus standard of care for the treatment of intractable pain associated with cancer.
Detailed description
This study is a multicenter, randomized Phase 3 study to assess the safety and efficacy of a single epidural administration of Resiniferatoxin versus standard of care (SOC) for the treatment of intractable pain associated with cancer. Subjects will be followed for 12 weeks after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resiniferatoxin | Experimental | Drug: ResiniferatoxinSingle dose of Resiniferatoxin (25 mcg in 3 mL) injected epidurally |
| Standard of Care | Active comparator | Other: Standard of CareStandard of care treatment as determined by the investigator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Histologically confirmed clinical diagnosis of advanced cancer or metastasis.
- Pain in the target area (lower thoracic or chest level down to lower extremities) most likely attributed to cancer as per Investigator.
- Pain severity at the target area is moderate-to-severe, defined as worst pain ≥6 on the NPRS during screening (average of the 3 days prior to Day 1), despite available pain therapy or analgesia. Subjects with multiple sites of pain are eligible as long as the intensity of pain at the intended target location for treatment fulfills the score of ≥6 and can be differentiated from other areas.
- Must report NPRS scores in the daily diary for at least 3 days prior to Day 1.
- Must be at least 18 years of age or older at Screening.
Key exclusion criteria (19 listed)
- Undergoing or have plans to undergo changes to current cancer treatment from 7 days prior to Day 1 to 4 weeks after Day 1. Continuation of existing anti-cancer therapy without any planned change in dose or regimen is permitted. Participants may receive new cancer therapy 4 weeks after Day 1 including investigational agents in another clinical trial while participating in this study. If participating in another trial, it is requested that the subject agree to continue clinic visits and completion of patient diaries in this trial.
- Participants with leptomeningeal metastases in the lumbar area.
- Level of intended epidural injection is in the site of prior lumbar spine surgical procedures, such as posterior spinal fusions, that could impair the ability to perform the injection, as assessed by the Investigator.
- Evidence of increased intracranial pressure as determined by symptoms, history, physical examination, and/or magnetic resonance imaging (MRI).
- Patients with an intra-thecal pump implanted within 2 weeks of the baseline visit will be excluded. Pump placement during the study will not be permitted for 4 weeks after the study drug is administered; and existing pump medications cannot be changed during that same initial 4 week period.
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 TRPV-1 agonist which works by specifically ablating nociceptive nerve fibers. | Drug | Resiniferatoxin |
| Standard of CareAlso: SOCStandard of care for intractable pain with the exception of intra-thecal pump placement as determined by the investigator. | Other | Standard of Care |
Primary outcome
Change in worst pain as assessed using the Numeric Pain Rating Scale (NPRS)
Time frame: Baseline to Week 4
Change from baseline to Week 4 in the intensity of worst pain over the previous 24 hours in the area targeted for treatment as measured by the 11-point NPRS (0-10 where 0 is no pain and 10 is worst pain imaginable)
6 secondary outcomes
Change in worst pain as assessed using the NPRS
Time frame: Baseline to Weeks 8 and 12
Change in area under the curve (AUC) of worst pain as assessed using the NPRS
Time frame: Baseline through Week 4
Incidence and severity of adverse events (AEs)
Time frame: Baseline through Week 12
Change in Quality of Life (QOL) as assessed using the modified Brief Pain Inventory-Short Form (BPI-SF)
Time frame: Baseline to Week 4
Duration of response in subjects who experienced ≥20% decrease from baseline in worst pain as assessed using the NPRS
Time frame: Randomization through Week 12
Change in intensity of average pain as assessed using the NPRS
Time frame: Baseline to Week 4
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2021.
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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.
Monica Luchi, MD study director
Sorrento Therapeutics
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Resiniferatoxin in people with Pain, Intractable and Pain Cancer, run by Sorrento Therapeutics, Inc..
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 12 inclusion and 19 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: withdrawn, as of the sponsor's last update on 9 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change in worst pain as assessed using the Numeric Pain Rating Scale (NPRS) (time frame: Baseline to Week 4). 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 9 Nov 2021.