drugset / Trial / NCT00246103
Phase I Trial of Valproic Acid and Epirubicin in Solid Tumor Malignancies
Phase 1
Completed
82 enrolled
H. Lee Moffitt Cancer Center and Research Institute
National Cancer Institute (NCI) · collabPfizer · collab
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2004-03
- Primary completion
- 2008-04
- Completion
- 2008-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cyclophosphamide | Other / unclassified | 500 mg/m2 | — |
| Subject | Epirubicin | Small molecule | 75 mg/m2 | — |
| Subject | Valproic Acid | Small molecule | 15 mg/kg | Intravenous |
| Subject | fluorouracil | Small molecule | 500 mg/m2 | — |