Study to Evaluate Safety and MTD of Epidural Resiniferatoxin Injection for Treatment of Intractable Cancer Pain
- Registration Number
- NCT03226574
- Lead Sponsor
- Sorrento Therapeutics, Inc.
- Brief 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.
- Detailed Description
All subjects who received RTX will be included in the analyses and summaries of safety, efficacy, PD, and PK assessments.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 17
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description RTX epidural injection Resiniferatoxin Epidural injection of 1.5mL/min RTX under the guidance of epidurogram.
- Primary Outcome Measures
Name Time Method Dose limiting toxicity (DLT) 3-month Grade 3 or 4 Toxicity associated with RTX administration
Maximum tolerated dose (MTD) 3-month Maximum dose without a Grade 3 or 4 toxicity
- Secondary Outcome Measures
Name Time Method Numeric Pain Rating Scale (NPRS) Day-28 to Day90 daily Daily average pain and daily worst pain on a 0-10 scale
Trial Locations
- Locations (4)
University of Miami/Sylvester Comprehensive Cancer Center
🇺🇸Miami, Florida, United States
Hermann Drive Surgical Hospital
🇺🇸Houston, Texas, United States
Brigham & Women's Hospital
🇺🇸Boston, Massachusetts, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States