A Phase Ib, Open-label, Multi-center Dose-finding Study of Oral Panobinostat (LBH589) in Combination With Ara-C and Mitoxantrone as Salvage Therapy for Refractory or Relapsed Acute Myeloid Leukemia

Phase 1 Completed 59 enrolled Novartis Pharmaceuticals

NaSingle-groupOpen-labelTreatment

Summary

The study will determine the maximal tolerated dose (MTD) of panobinostat administered in combination with a fixed combination of cytarabine (ara-C) and mitoxantrone in adult patients with relapsed or refractory acute myeloid leukemia (AML).

Timeline

Start: 2009-09
Primary completion: 2012-02
Completion: 2012-02

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Panobinostat	Small molecule	—	Oral

A Phase Ib, Open-label, Multi-center Dose-finding Study of Oral Panobinostat (LBH589) in Combination With Ara-C and Mitoxantrone as Salvage Therapy for Refractory or Relapsed Acute Myeloid Leukemia

Summary

Timeline

Drugs

Indications