study to evaluate safety and mtd of epidural resiniferatoxin injection for treatment of intractable cancer pain

Conditions: Intractable Cancer Pain

Summary: 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.

Eligibility criteria:
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 administration. * 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 pregnancies. * 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 breastfeeding. * subjects with any medical condition that could adversely impact study participation or assessments. * 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 uln. * 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.

Keywords: resiniferatoxin rtx cancer pain