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NCT00400023 · ClinicalTrials.gov registry record · Phase 1
A Phase 1, Open-Label, Randomized, Cross-Over, Pharmacokinetic Study Evaluating the Effect of S-1 on Advanced Solid Tumors
A Phase 1 study, sponsored by Taiho Oncology.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT00400023: Completed Phase 1 study, sponsored by Taiho Oncology.
NCT00400023 is a Phase 1 study that has completed, run by Taiho Oncology. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00400023, a Phase 1 study, has completed, sponsored by Taiho Oncology.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
This is a Phase 1, open-label, randomized, 2-sequence, cross-over, pharmacokinetic (PK) study evaluating the effect of the DPD inhibitory action of CDHP as an S-1 component compared with FT alone on the PK of 5-FU in patients with advanced solid tumors. The study will be conducted in 2 parts (Cross-Over Pharmacokinetic Phase and S-1 Extension Phase).
Interventions
- DRUG S-1
- DRUG FT
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2006-09 |
| Est. Completion | 2007-05 |
| Phase | Phase 1 |
What the finished NCT00400023 record still lists
NCT00400023 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 2 interventions - of which S-1 is the first listed.
NCT00400023 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00400023 about?
NCT00400023 is a clinical study titled "A Phase 1, Open-Label, Randomized, Cross-Over, Pharmacokinetic Study Evaluating the Effect of S-1 on Advanced Solid Tumors". This is a Phase 1, open-label, randomized, 2-sequence, cross-over, pharmacokinetic (PK) study evaluating the effect of the DPD inhibitory action of CDHP as an S-1 component compared with FT alone on the PK of 5-FU in patients with advanced solid tumors. The study will be conducted in 2 parts (Cross-...
What is the current status of trial NCT00400023?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2006-09. Estimated completion is 2007-05.
What interventions are being tested in trial NCT00400023?
The interventions under investigation include: S-1 (DRUG), FT (DRUG).
Who is sponsoring clinical trial NCT00400023?
This trial is sponsored by Taiho Oncology, which has 52 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00400023's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 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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