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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 is a Phase 1 study that has completed, run by Taiho Oncology. The registered enrollment target is 12 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00400023
The ClinicalTrials.gov registry entry for NCT00400023 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Taiho Oncology, which has 52 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which S-1 is the first listed.
NCT00400023 reports 0 study locations.
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.
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