drugset / Trial / NCT01879085
Study of Vorinostat in Combination With Gemcitabine and Docetaxel in Advanced Sarcoma
NaSequentialOpen-labelTreatment
Summary
This is a Phase Ib/II experimental, open-label, dose escalation, active treatment study designed to determine the safety, tolerability, and recommended dose of the combination. During the Phase 2 portion of the study, we will assess progression-free survival (PFS), overall survival (OS),overall response rate (ORR), correlative endpoints, DNA methylation measured by microarray, and expression level of the genes as measured by microarray
Timeline
- Start
- 2013-09-24
- Primary completion
- 2021-04-15
- Completion
- 2021-04-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Docetaxel | Small molecule | 75 mg/m2 | Intravenous |
| Subject | Gemcitabine | Small molecule | 900 mg/m2 | Intravenous |
| Subject | Vorinostat | Small molecule | 200 mg | Oral |
| Subject | Vorinostat | Small molecule | 300 mg | Oral |
| Background | Pegfilgrastim | Protein / enzyme biologic | 6 mg | Subcutaneous |