A Phase Ib/IIb, Open-label, Multi-center, Study of Oral Panobinostat Administered With 5-Azacitidine (in Adult Patients With Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML), or Acute Myeloid Leukemia (AML).

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

113

Participants

Timeline

Start Date

December 2, 2009

Primary Completion Date

April 29, 2019

Study Completion Date

April 29, 2019

Conditions
Myelodysplastic SyndromesChronic Myelomonocytic LeukemiaAcute Myeloid Leukemia
Interventions
DRUG

Panobinostat (LBH589)

Panobinostat was supplied by Novartis as immediate-release hard gelatin capsules in strengths of 5 mg, 10 mg, and 20 mg packaged in high density polyethylene bottles.

DRUG

5-Azacytidine

Trial Locations (38)

1097

Novartis Investigative Site, Budapest

1205

Novartis Investigative Site, Geneva

4031

Novartis Investigative Site, Basel

4032

Novartis Investigative Site, Debrecen

5530

Novartis Investigative Site, Yvoir

7400

Novartis Investigative Site, Kaposvár

8000

Novartis Investigative Site, Bruges

9007

Novartis Investigative Site, Sankt Gallen

10017

Memorial Sloan Kettering Sloan Kettering 2, New York

10330

Novartis Investigative Site, Bangkok

10700

Novartis Investigative Site, Bangkok

28006

Novartis Investigative Site, Madrid

29010

Novartis Investigative Site, Málaga

29425

Medical University of South Carolina -Hollings Cancer Center MUSC, Charleston

30912

Georgia Health Sciences University Dept. of MCG, Augusta

44195

Cleveland Clinic Foundation Cleve Clinic, Cleveland

46202

Goshen Center for Cancer Care IU Cancer Center, Indianapolis

50134

Novartis Investigative Site, Florence

60590

Novartis Investigative Site, Frankfurt

66160

University of Kansas Hospital and Medical Center SC - Univ KS, Kansas City

77030

University of Texas MD Anderson Cancer Center Dept of MD Anderson (16), Houston

79106

Novartis Investigative Site, Freiburg im Breisgau

89124

Novartis Investigative Site, Reggio Calabria

93009

Novartis Investigative Site, Bobigny

02215

Dana Farber Cancer Institute Beth Israel Deaconess Med Ctr, Boston

A-6020

Novartis Investigative Site, Innsbruck

A-1100

Novartis Investigative Site, Vienna

T6G 2B7

Novartis Investigative Site, Edmonton

M5G 2M9

Novartis Investigative Site, Toronto

H 6725

Novartis Investigative Site, Szeged

00161

Novartis Investigative Site, Roma

05505

Novartis Investigative Site, Seoul

06351

Novartis Investigative Site, Seoul

08035

Novartis Investigative Site, Barcelona

413 45

Novartis Investigative Site, Gothenburg

SE-118 83

Novartis Investigative Site, Stockholm

EC1A 7BE

Novartis Investigative Site, London

WV10 0QP

Novartis Investigative Site, Wolverhampton

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY