Trials / Completed
CompletedNCT03226574
Study to Evaluate Safety and MTD of Epidural Resiniferatoxin Injection for Treatment of Intractable Cancer Pain
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 17 (actual)
- Sponsor
- Sorrento Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Resiniferatoxin | single dose (0.4, 1, 2, 4, 8,15, 25 or 35 mcg), epidural injection |
Timeline
- Start date
- 2017-09-01
- Primary completion
- 2020-03-18
- Completion
- 2020-06-18
- First posted
- 2017-07-24
- Last updated
- 2020-10-20
Locations
4 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03226574. Inclusion in this directory is not an endorsement.