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NCT00246103 · ClinicalTrials.gov registry record · Phase 1
Phase I Trial of Valproic Acid and Epirubicin in Solid Tumor Malignancies
A Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 82
- Enrollment target
NCT00246103 is a Phase 1 study that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 82 participants.
The verdict
NCT00246103, a Phase 1 study, has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 82 participants
- Enrollment target
Study Summary
This is a Phase I dose escalation trial with escalating doses of Valproic acid and one dose escalation step of epirubicin. VPA will be escalated starting at a dose that is recommended for use as an anti-convulsant or to treat migraine headaches. Epirubicin will be given by infusion on day 3 after the last dose of divalproex. The study will determine the highest dose that these two drugs can be given together and as part of a multidrug regimen with 5-fluorouracil and cyclophosphamide.
Interventions
- DRUG 5-fluorouracil
- DRUG Epirubicin
- DRUG Valproic acid
- DRUG Cyclophosphamide.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 82 participants |
| Start Date | 2004-03 |
| Est. Completion | 2008-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00246103
The ClinicalTrials.gov registry entry for NCT00246103 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 82 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is H. Lee Moffitt Cancer Center and Research Institute, which has 502 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which 5-fluorouracil is the first listed.
NCT00246103 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00246103 about?
NCT00246103 is a clinical study titled "Phase I Trial of Valproic Acid and Epirubicin in Solid Tumor Malignancies". This is a Phase I dose escalation trial with escalating doses of Valproic acid and one dose escalation step of epirubicin. VPA will be escalated starting at a dose that is recommended for use as an anti-convulsant or to treat migraine headaches. Epirubicin will be given by infusion on day 3 after th...
What is the current status of trial NCT00246103?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 82 participants. The study started on 2004-03. Estimated completion is 2008-04.
What interventions are being tested in trial NCT00246103?
The interventions under investigation include: 5-fluorouracil (DRUG), Epirubicin (DRUG), Valproic acid (DRUG), Cyclophosphamide. (DRUG).
Who is sponsoring clinical trial NCT00246103?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
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