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NCT03512756 · ClinicalTrials.gov registry record · Phase 2
A Randomized Phase 2/3 Multi-Center Study of SM-88 in Participants With Metastatic Pancreatic Cancer
A Phase 2 study, sponsored by Tyme.
- Terminated
- Registry status
- Phase 2
- Development phase
- 130
- Enrollment target
NCT03512756 is a Phase 2 study that was terminated before completion, run by Tyme. The registered enrollment target is 130 participants.
The verdict
NCT03512756, a Phase 2 study, was terminated before completion, sponsored by Tyme.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 130 participants
- Enrollment target
Study Summary
A prospective, open-label phase 2/3 trial in metastatic pancreatic cancer participants who have failed two lines of prior systemic therapy. The trial is designed to evaluate the safety and efficacy of SM-88 used with MPS (methoxsalen, phenytoin and sirolimus) in pancreatic cancer and will measure multiple endpoints, including overall survival, progression free survival, relevant biomarkers, quality of life, safety, and overall response rate. (Part 1 enrollment complete) In the initial stage of the trial (36 participants), two dose levels of SM-88's metyrosine-derivative was evaluated. (Part 2 actively enrolling) The second part will consist of a subsequent expansion of the trial to further assess safety and efficacy of SM-88 used with MPS containing the selected SM-88 RP2D from Part 1. A total of 250 participants in the second part will be randomized 1:1 either to the SM-88 arm (125 participants) or Physician's Choice of therapy for the Control Arm (125 participants). Participants should have previously received two lines of prior systemic therapy.
Interventions
- DRUG SM-88 used with MPS (methoxsalen, phenytoin, sirolimus)
- DRUG Capecitabine, Gemcitabine, and 5-FU
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 130 participants |
| Start Date | 2018-03-27 |
| Est. Completion | 2021-12-28 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03512756
The ClinicalTrials.gov registry entry for NCT03512756 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 130 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tyme, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which SM-88 used with MPS (methoxsalen, phenytoin, sirolimus) is the first listed.
NCT03512756 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03512756 about?
NCT03512756 is a clinical study titled "A Randomized Phase 2/3 Multi-Center Study of SM-88 in Participants With Metastatic Pancreatic Cancer". A prospective, open-label phase 2/3 trial in metastatic pancreatic cancer participants who have failed two lines of prior systemic therapy. The trial is designed to evaluate the safety and efficacy of SM-88 used with MPS (methoxsalen, phenytoin and sirolimus) in pancreatic cancer and will measure mu...
What is the current status of trial NCT03512756?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 130 participants. The study started on 2018-03-27. Estimated completion is 2021-12-28.
What interventions are being tested in trial NCT03512756?
The interventions under investigation include: SM-88 used with MPS (methoxsalen, phenytoin, sirolimus) (DRUG), Capecitabine, Gemcitabine, and 5-FU (DRUG).
Who is sponsoring clinical trial NCT03512756?
This trial is sponsored by Tyme, which has 2 total clinical trials registered on ClinicalTrials.gov.
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