Spots Global Cancer Trial Database for Study to Evaluate Safety and MTD of Epidural Resiniferatoxin Injection for Treatment of Intractable Cancer Pain
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Trial Identification
Brief Title: Study to Evaluate Safety and MTD of Epidural Resiniferatoxin Injection for Treatment of Intractable Cancer Pain
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
Study ID: NCT03226574
Conditions
Interventions
Study Description
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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Miami/Sylvester Comprehensive Cancer Center, Miami, Florida, 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
Contact Details
Name: Monica Luchi, MD
Affiliation: Sorrento Therapeutics, Inc.
Role: STUDY_DIRECTOR
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