drugset / Trial / NCT00925132
Treatment of Resistant Metastatic Melanoma Using Decitabine, Temozolomide and Panobinostat
Phase 1/2
Terminated
39 enrolled
University of Iowa
Holden Comprehensive Cancer Center · collabNovartis Pharmaceuticals · collab
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to treat metastatic melanoma with a combination of standard chemotherapy (decitabine and Temozolomide in a dose escalation scheme) with an study drug called panobinostat. This combination is proposed to unlock genes that may contribute to mechanisms that cause tumor growth. The primary objectives of this study are: * To evaluate the safety and tolerability of the proposed schedule of decitabine, temozolomide and panobinostat in the treatment of metastatic melanoma. * To define any Dose Limiting Toxicity (DLT) and maximum tolerated dose (MTD) of the combination of decitabine, temozolomide and panobinostat.
Timeline
- Start
- 2009-12
- Primary completion
- 2014-11
- Completion
- 2016-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Decitabine | Small molecule | 0.1 mg/kg | Subcutaneous |
| Subject | Decitabine | Small molecule | 0.2 mg/kg | Subcutaneous |
| Subject | Panobinostat | Small molecule | 10 mg | Oral |
| Subject | Panobinostat | Small molecule | 20 mg | Oral |
| Subject | Panobinostat | Small molecule | 30 mg | Oral |
| Subject | Temozolomide | Small molecule | 150 mg/m2 | Oral |