drugset / Trial / NCT02349867
Neoadjuvant Chemotherapy Followed by Radiation Therapy and Gemcitabine/Sorafenib/Vorinostat in Pancreatic Cancer
Phase 1
Completed
23 enrolled
Virginia Commonwealth University
National Cancer Institute (NCI) · collab
NaSingle-groupOpen-labelTreatment
Summary
Determine the doses and schedule appropriate for phase 2 study of sorafenib and vorinostat with concurrent gemcitabine and radiation therapy (RT) as neoadjuvant treatment of pancreatic cancer following chemotherapy. Recommended phase II dose RP2Ds and schedule of sorafenib and vorinostat defined as the doses and schedule that are the same as or less than the maximum tolerated dose (MTD) and schedule.
Timeline
- Start
- 2015-01-29
- Primary completion
- 2020-05-13
- Completion
- 2022-05-13
Publications
- Tost J, Ak-Aksoy S, Campa D, Corradi C, Farinella R, Ibanez-Costa A, Dubrot J, Earl J, Melian EB, Kataki A, Kolnikova G, Madjarov G, Chaushevska M, Strnadel J, Tanic M, Tomas M, Dubovan P, Urbanova M, Buocikova V, Smolkova B. Leveraging epigenetic alterations in pancreatic ductal adenocarcinoma for clinical applications. Semin Cancer Biol. 2025 Feb;109:101-124. doi: 10.1016/j.semcancer.2025.01.003. Epub 2025 Jan 23.
- Booth L, Poklepovic A, Dent P. Neratinib decreases pro-survival responses of [sorafenib + vorinostat] in pancreatic cancer. Biochem Pharmacol. 2020 Aug;178:114067. doi: 10.1016/j.bcp.2020.114067. Epub 2020 Jun 3.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sorafenib | Small molecule | — | Oral |
| Subject | Vorinostat | Small molecule | — | Oral |
| Background | Gemcitabine | Small molecule | 200 mg/m2 | Intravenous |