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Study to Assess 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.

Purpose of Study

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.

Eligibility

Age:
18 +
Sex:
All

Key Inclusion / Exclusion Criteria

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

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

Conditions:

Pain

Status:

Not yet recruiting

Phase:

Phase 2

Study ID

NCT05067257

Read Detailed Summary

Start Date / End Date:

01/06/2022 -

Enrollment:

120

Full Details:

https://clinicaltrials.gov/ct2/show/NCT05067257

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