drugset / Trial / NCT00978432
Epigenetic Modulation in Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is evaluate the response, safety and tolerability in subjects receiving the investigational drugs, RAD001 and LBH589. Subjects in Part 1 will receive one drug for four cycles followed by 4 cycles of the second drug unless they achieve complete remission. Subjects in a complete remission may receive up to 6 cycles of study drug and will not receive the next study drug until there is evidence of disease progression. Subjects in Part 2 will receive both drugs together for at least 2 cycles and up to 13 if tolerated.
Timeline
- Start
- 2012-02
- Primary completion
- 2015-04
- Completion
- 2016-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Everolimus | Small molecule | 7.5 mg | Oral |
| Subject | Everolimus | Small molecule | 10 mg | Oral |
| Subject | Panobinostat | Small molecule | 15 mg | Oral |
| Subject | Panobinostat | Small molecule | 20 mg | Oral |
| Subject | Panobinostat | Small molecule | 40 mg | Oral |