Intractable Cancer Pain Clinical Trial
Official title:
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
| Verified date | October 2020 |
| Source | Sorrento Therapeutics, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 17 |
| Est. completion date | June 18, 2020 |
| Est. primary completion date | March 18, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Brigham & Women's Hospital | Boston | Massachusetts |
| United States | Duke University Medical Center | Durham | North Carolina |
| United States | Hermann Drive Surgical Hospital | Houston | Texas |
| United States | University of Miami/Sylvester Comprehensive Cancer Center | Miami | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Sorrento Therapeutics, Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Daily analgesic consumption (DAC) log | Consumption of analgesics compared to baseline | Day-28 to Day90 daily | |
| Other | Brief Pain Inventory-Short Form (BPI-SF) | Quality of life compared to baseline by the total score | Day-28, Day1, Day2/3, Day8, Day15, Day30, Day60 and Day90 | |
| Other | Patient Global Impression of Change (PGIC) | Patient-reported rating of improvement on a 7-point scale, ranking the improvement from (1) to (7), with (1) being no change or worse to (7) being a great deal better and a considerable improvement that has made all the difference. | Day2/3, Day8, Day15, Day30, Day60 and Day90 | |
| Other | Modified Numeric Pain Rating Scale (modified NPRS) | A 11-point scale for rating average and worst pain at the location intended to be treated with RTX within 12 hours of the clinical visit, with 0 being no pain to 10 being worst pain imaginable. | Day1, Day2/3, Day8, Day15, Day30, Day60 and Day90 | |
| Other | Modified Brief Pain Inventory-Short Form (modified BPI-SF) | Quality of life affected by pain at the location intended to be treated with RTX, each question rates pain level and pain interference on a 0 to 10 scale. For pain level questions, 0 represents no pain and 10 represents pain as bad as can be imagined. For pain interference questions, 0 is "does not interfere" and 10 is "completely interferes". | Day1, Day2/3, Day8, Day15, Day30, Day60 and Day90 | |
| Primary | Dose limiting toxicity (DLT) | Grade 3 or 4 Toxicity associated with RTX administration | 3-month | |
| Primary | Maximum tolerated dose (MTD) | Maximum dose without a Grade 3 or 4 toxicity | 3-month | |
| Secondary | Numeric Pain Rating Scale (NPRS) | Daily average pain and daily worst pain on a 0-10 scale | Day-28 to Day90 daily |