Scintilla RTX Phase 1b- Uncontrolled Pain Due to Advanced Cancer or Cancer that has Spread - Clinical Trial
What is the Purpose of this Study?
We are doing this study to learn whether a study drug called resiniferatoxin (also called RTX) is safe and effective in treating severe pain.
Uncontrolled pain due to advanced cancer or cancer that has spread (metastasized)
Who Can Participate in the Study?
- With advanced cancer or metastasis that has not responded to standard therapy and causing uncontrolled pain from the chest down to the lower legs.
- With moderate-to-severe pain
- Who are not currently seeking or receiving potentially curative therapies for cancer (palliative therapy is acceptable).
For more information about who can be in the study please contact the study team.
What is Involved?
If you choose to join this study, you will:
- Have 8 clinic visits, one of which will require you to stay for up to 10 hours
- Visit 1 will include a physical exam, ECG, blood and urine tests.
-- You will be also be taught how to report your pain score on a diary (log).
- Visit 2 you will receive the study drug and you will stay in the hospital for up to 8 hours and blood and urine samples will be collected.
-- Blood and urine sample will be collected.
- Visits 3-8: will include a physical exam, ECG, blood and urine sample and a review of your pain logs.
You'll be in the study for about 3 and a half months.