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NCT00398424 · ClinicalTrials.gov registry record · Phase 1
Evaluating Patients With Impaired Hepatic Function
A Phase 1 study, sponsored by Taiho Oncology.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT00398424 is a Phase 1 study that has completed, run by Taiho Oncology. The registered enrollment target is 24 participants.
The verdict
NCT00398424, a Phase 1 study, has completed, sponsored by Taiho Oncology.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
This is a Phase I, Open-Label study evaluating the PK of S-1 components and their metabolites in patients with advanced solid tumors and varying degrees of hepatic function defined by the NCI classification for hepatic impairment. Patients will be stratified into 4 Cohorts- Normal, Mild, Moderate or Severe. Six patients will be enrolled inot each cohort and receive S-1.
Interventions
- DRUG S-1/Cisplatin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2006-02 |
| Est. Completion | 2009-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00398424
The ClinicalTrials.gov registry entry for NCT00398424 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 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 1 intervention - of which S-1/Cisplatin is the first listed.
NCT00398424 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00398424 about?
NCT00398424 is a clinical study titled "Evaluating Patients With Impaired Hepatic Function". This is a Phase I, Open-Label study evaluating the PK of S-1 components and their metabolites in patients with advanced solid tumors and varying degrees of hepatic function defined by the NCI classification for hepatic impairment. Patients will be stratified into 4 Cohorts- Normal, Mild, Moderate or...
What is the current status of trial NCT00398424?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2006-02. Estimated completion is 2009-03.
What interventions are being tested in trial NCT00398424?
The interventions under investigation include: S-1/Cisplatin (DRUG).
Who is sponsoring clinical trial NCT00398424?
This trial is sponsored by Taiho Oncology, which has 52 total clinical trials registered on ClinicalTrials.gov.
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