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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
17
single dose (0.4, 1, 2, 4, 8,15, 25 or 35 mcg), epidural injection
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
Dose limiting toxicity (DLT)
Grade 3 or 4 Toxicity associated with RTX administration
Time frame: 3-month
Maximum tolerated dose (MTD)
Maximum dose without a Grade 3 or 4 toxicity
Time frame: 3-month
Numeric Pain Rating Scale (NPRS)
Daily average pain and daily worst pain on a 0-10 scale
Time frame: Day-28 to Day90 daily
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