drugset
drugset / Trial / NCT01463046

Phase I Dose Finding and Proof-of-concept Study of Panobinostat With Standard Dose Cytarabine and Daunorubicin for Untreated Acute Myeloid Leukemia or Advanced Myelodysplastic Syndrome

NCT01463046 ↗

Phase 1 Completed 29 enrolled University of California, San Francisco Novartis · collab
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to see if Panobinostat is safe to give to patients and to determine the best dose to give in combination with standard cytarabine and daunorubicin chemotherapy.

Timeline

Start
2012-01
Primary completion
2015-11-14
Completion
2018-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Panobinostat Small molecule 20 mg Oral
Subject Panobinostat Small molecule 40 mg Oral
Subject Panobinostat Small molecule 60 mg Oral
Background Cytarabine Small molecule 100 mg/m2 Intravenous
Background Daunorubicin Small molecule 60 mg/m2 Intravenous

Indications

acute myeloid leukemia myelodysplastic syndrome