drugset / Trial / NCT00978432

Epigenetic Modulation in Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

NCT00978432

Phase 2 Terminated 50 enrolled Anne Beaven, MD Novartis · collab
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

EvaluationDrugModalityDoseRoute
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