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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: Completed Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
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, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
MTD of Valproic acid in combination with Epirubicin. The maximum tolerated dose (MTD) will be defined as the highest dose level at which less than 2 out of 6 patients (\<33%) experience DLT in Cycle 1. A dose limiting toxicity (DLT) will be defined as any one of the specific adverse events (AEs) outlined in the protocol, occurring during Cycle 1 when considered related to therapy that is part of this study.
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 |
What the finished NCT00246103 record still lists
NCT00246103 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 82 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% higher).
The record links to 0 conditions, and to 4 interventions - of which 5-fluorouracil is the first listed.
NCT00246103 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00246103's enrollment target sits among peer trials
82 669th of 2000 higher than 1,330 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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