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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: Clinical Trial Phase 2 study, sponsored by Tyme.
NCT03512756 is a Phase 2 study that was terminated before completion, run by Tyme. The registered enrollment target is 130 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
OS was defined as the number of days between the first study drug administration and death from any cause. Results are reported in weeks.
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 |
Why NCT03512756 stopped before completion
NCT03512756 is an interventional study that assigns participants to a tested intervention. The registered 130 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
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 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03512756's enrollment target sits among peer trials
130 543rd of 2000 higher than 1,448 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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