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NCT02191761 · ClinicalTrials.gov registry record · Phase 1
Safety and Pharmacokinetics of SM04755 in Subjects With Advanced Colorectal, Gastric, Hepatic, or Pancreatic Cancer
A Phase 1 study, sponsored by Biosplice Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
NCT02191761: Completed Phase 1 study, sponsored by Biosplice Therapeutics.
NCT02191761 is a Phase 1 study that has completed, run by Biosplice Therapeutics. The registered enrollment target is 13 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02191761, a Phase 1 study, has completed, sponsored by Biosplice Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
Study Summary
This is an open-label, multi-center, dose escalation study in adult subjects with advanced colorectal, gastric, hepatic or pancreatic cancer. The study will evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of SM04755 administered orally. Upon determination of the maximum tolerated dose (MTD), expansion cohorts may be enrolled.
Interventions
- DRUG SM04755
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2014-06-19 |
| Est. Completion | 2015-05-20 |
| Phase | Phase 1 |
What the finished NCT02191761 record still lists
NCT02191761 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 1 intervention - of which SM04755 is the first listed.
NCT02191761 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02191761 about?
NCT02191761 is a clinical study titled "Safety and Pharmacokinetics of SM04755 in Subjects With Advanced Colorectal, Gastric, Hepatic, or Pancreatic Cancer". This is an open-label, multi-center, dose escalation study in adult subjects with advanced colorectal, gastric, hepatic or pancreatic cancer. The study will evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of SM04755 administered orally. Upon determination of the ma...
What is the current status of trial NCT02191761?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2014-06-19. Estimated completion is 2015-05-20.
What interventions are being tested in trial NCT02191761?
The interventions under investigation include: SM04755 (DRUG).
Who is sponsoring clinical trial NCT02191761?
This trial is sponsored by Biosplice Therapeutics, which has 20 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02191761's enrollment target sits among peer trials
13 1847th of 2000 higher than 149 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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