Study to Evaluate Safety and MTD of Epidural Resiniferatoxin Injection for Treatment of Intractable Cancer Pain

Age Range:18 - Any
Start Date:September 1, 2017
End Date:November 2019
Contact:Stephen Klincewicz, DO, MPH, JD
Phone:(646) 835-5734

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A Multicenter, Open-Label, Phase 1b Study to Assess the Safety and Define the Maximally Tolerated Dose of Epidural Resiniferatoxin Injection for the Treatment of Intractable Pain Associated With Cancer

The study is a multicenter, open-label Phase 1b single dose escalation safety study for adult
subjects with intractable pain associated with cancer in any area below the mid-thoracic
level who meet all other eligibility criteria.

All subjects who received RTX will be included in the analyses and summaries of safety,
efficacy, PD, and PK assessments.

Inclusion Criteria:

- Histologically confirmed advanced cancer or metastasis, which has not responded to
standard therapy, producing intractable chronic pain in any area below the
mid-thoracic level.

- Male or female subjects must be at least 18 years of age.

- Must have a worst pain score ≥6 on the NPRS at Screening visit.

- Subjects not seeking or receiving potentially curative therapies for cancer.
Palliative therapy is acceptable if the therapy started and is stable prior to IP

- Sexually active female subjects of childbearing potential and male subjects capable of
fathering a child must be willing to use an effective method of contraception to avoid

- Must be willing and capable of understanding and cooperating with the requirements of
the study.

- Must be able to understand and complete study-related forms and adequately communicate
with the investigator and/or site staff.

- Must have provided written informed consent prior to participating in any
study-related activity.

- Subjects able to complete the study duration.

Exclusion Criteria:

- Subjects with leptomeningeal metastases in lumbar area.

- Undergoing or have plans to undergo changes to current cancer treatment during the
study through the Day15 assessment.

- Had prior lumbar spine surgical procedures that could impair the ability to perform
the injection.

- Evidence of brain pathology or increase intracranial pressure.

- Presence of an IT shunt.

- Has evidence or a coagulopathy or hemostasis problem.

- Subjects with a total neutrophil count <1500 cells/mm3.

- Subjects with serum creatinine ≥1.5 mg/dL.

- Is febrile or has other evidence of an infection within 7 days of planned injection.

- Has an allergy or hypersensitivity to chili peppers, capsaicin, or radiographic
contrast agents.

- Female subjects who are pregnant, are planning on becoming pregnant, or are currently

- Subjects with any medical condition that could adversely impact study participation or

- Subjects who have received new anti-cancer treatments and there is less than one week
or four half-lives of the investigational drug, whichever is greater, between the last
dose of the new drug and the planned day of IP administration; or had a change in the
dose or schedule of the anti-cancer treatments within one week or four half-lives,
whichever is greater, between the last dose of the anti-cancer treatment and the
planned day of IP administration; or are scheduled to receive a new anti-cancer
therapy or investigational product prior to completion of the Day 15 visit.

- Subjects with additional loci of pain above the mid-thoracic level or other pain
disorder due to non-cancer etiology, unless both the investigator and the subject are
clearly able to distinguish the additional pain from the target pain due to cancer.

- Liver cirrhosis or severe hepatic impairment, with liver function test 3 times above

- Sensory/peripheral neuropathy of CTCAE Grade 2 or higher.

- Nonstudy related minor surgical procedure ≤5 days or major surgical procedure ≤21 days
prior to Screening visit.

- Subjects who have not completely recovered from any toxicities from previous
chemotherapy, hormone therapy, immunotherapy, or radiotherapies that are CTCAE Grade 3
or higher.

- Arterial thrombi (including stroke), myocardial infarction, admission for unstable
angina, cardiac angioplasty, or stenting within 3 months prior to Screening visit.

- Corrected QT using Fridericia's formula (QTcF) prolongation.

- Evidence or history of bleeding disorder within 4 weeks prior to IP administration.

- Known HIV or acquired immunodeficiency syndrome-related illness, acute or history of
chronic hepatitis B or C.
We found this trial at
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(305) 243-1000
Principal Investigator: Roy C Levitt, MD
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Principal Investigator: Richard Boortz-Marx, MD
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