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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 is a Phase 1 study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 23 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02036281
The ClinicalTrials.gov registry entry for NCT02036281 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Texas Southwestern Medical Center, which has 837 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Substance P-Saporin is the first listed.
NCT02036281 reports 0 study locations.
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.
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