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NCT02036281 · ClinicalTrials.gov registry record · Phase 1
A Phase 1 Study of Substance P-Saporin in Terminal Cancer Patients With Intractable Pain
A Phase 1 study, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 23
- Enrollment target
NCT02036281: Completed Phase 1 study, sponsored by University of Texas Southwestern Medical Center.
NCT02036281 is a Phase 1 study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 23 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02036281, a Phase 1 study, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 23 participants
- Enrollment target
Study Summary
The subjects will be treated with a single dose of SP-SAP. They will receive the study drug SP-SAP via a percutaneous intraspinal catheter, they will be monitored for 4 hours and required to stay in the hospital for 24 hours for precautionary care. Their vital signs will be monitored and recorded immediately following the injection. After the catheter has been removed, the following assessments will be made physical exam including motor and sensory functions, and electrocardiogram. A neurologist will be available for consultation as needed. Beginning dose of SP-SAP will be 1 -mcg for the first cohort. Subsequent single patient dose cohorts as 2, 4, 8, 16, 32, 64 and 90 mcg intrathecally (into the spine). SP-SAP will be accrued and treated after four weeks observation for toxicities between cohorts. Study duration will be up to 6 months from the start of SP-SAP administration.
Primary Outcome
The response criteria are based on achievement of a 20% reduction in chronic pain or opioid dose within eight weeks of treatment as assessed by at least two of the measured parameters: VAS "pain bothersomeness." VAS "pain intensity," ODI, SF-36, EQ-5D, BDI, and medication use log. Safe doses of opioids will be determined by referring physician and symptoms are refractory if at maximal safe dose of opioids (not associated with severe side effects), the VAS score remains elevated above 3.
Interventions
- DRUG Substance P-Saporin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2014-01 |
| Est. Completion | 2016-09-28 |
| Phase | Phase 1 |
What the finished NCT02036281 record still lists
NCT02036281 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 1 intervention - of which Substance P-Saporin is the first listed.
NCT02036281 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02036281 about?
NCT02036281 is a clinical study titled "A Phase 1 Study of Substance P-Saporin in Terminal Cancer Patients With Intractable Pain". The subjects will be treated with a single dose of SP-SAP. They will receive the study drug SP-SAP via a percutaneous intraspinal catheter, they will be monitored for 4 hours and required to stay in the hospital for 24 hours for precautionary care. Their vital signs will be monitored and recorded im...
What is the current status of trial NCT02036281?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2014-01. Estimated completion is 2016-09-28.
What interventions are being tested in trial NCT02036281?
The interventions under investigation include: Substance P-Saporin (DRUG).
Who is sponsoring clinical trial NCT02036281?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02036281's enrollment target sits among peer trials
23 1596th of 2000 higher than 400 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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