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).

Completed · Phase 1/Phase 2

Conditions studied: Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, Acute Myeloid Leukemia

In brief

The purpose of this randomized, two-arm, open-label expansion phase study was to collect preliminary efficacy data of panobinostat at the recommended phase II dose (RPIID) level in combination with azacytidine (5-Aza) versus an active control arm 5-Aza alone. This randomized phase II part also allowed collecting safety data of panobinostat in combination with 5-Aza in comparison to single-agent 5-aza.

Key facts

Study ID

NCT00946647

Run by

Novartis Pharmaceuticals

People needed

113

Starts

2009-12-02

Expected to finish

2019-04-29

Last updated by the study team

2020-08-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Phase l:
• Patients with cytopathologically confirmed diagnosis of AML according to WHO criteria, excluding acute promyelocytic leukemia who are eligible for Vidaza treatment
• ECOG performance status greater less than or equal to 2
• Phase ll:
• Adult patients (age ≥ 18 years) who were candidates for treatment with 5-Aza and present with one of the following:
• intermediate-2 or high-risk myelodysplastic syndromes according to the International Prognostic Scoring System (IPSS). OR
• AML with multilineage dysplasia and maximum of 30% blasts (former RAEB-T according to FAB) OR
• chronic myelomonocytic leukemia (CMML)
• Patients must have had the following laboratory values unless elevations are considered due to MDS or leukemia: AST/SGOT and/or ALT/SGPT ≤ 2.5 x ULN; serum creatinine ≤ 1.5 x ULN; serum bilirubin (total and direct) ≤ 2 x ULN; electrolyte panel within normal ranges (WNL) for the institution.

You may not qualify if…

• Phase l:
• Prior treatment with deacetylase inhibitors
• Concurrent therapy with any other investigational agent
• Phase ll:
• Planned hematopoietic stem-cell transplantation (HSCT)
• Patients with therapy-related MDS
• Patients with therapy-related AML and/or relapsed/refractory AML
• Patients with impaired cardiac function including any of the following:
• Complete left bundle branch block or use of a permanent cardiac pacemaker, congenital long QT syndrome, history or presence of ventricular tachyarrhythmia, clinically significant resting bradycardia (<50 beats per minute), QTcF > 460 ms on screening ECG, or right bundle branch block + left anterior hemiblock (bifascicular block)
• Presence of unstable atrial fibrillation (ventricular response rate >100 bpm). Patients with stable atrial fibrillation are eligible provided they do not meet the other cardiac exclusion criteria
• Previous history of angina pectoris or acute MI within 6 months
• Screening LVEF <45% by echocardiography or MUGA
• Other clinically significant heart disease (e.g. uncontrolled hypertension or history of poor compliance with an antihypertensive regimen).
• Any of concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study. For example:
• Uncontrolled diabetes
• Active or uncontrolled infection
• Uncontrolled hypothyroidism
• Acute or chronic liver or renal disease
• Patient had evidence of clinically significant mucosal or internal bleeding

Where it is running

• Georgia Health Sciences University Dept. of MCG — Augusta, Georgia, United States
• Goshen Center for Cancer Care IU Cancer Center — Indianapolis, Indiana, United States
• University of Kansas Hospital and Medical Center SC - Univ KS — Kansas City, Kansas, United States
• Dana Farber Cancer Institute Beth Israel Deaconess Med Ctr — Boston, Massachusetts, United States
• Memorial Sloan Kettering Sloan Kettering 2 — New York, New York, United States
• Cleveland Clinic Foundation Cleve Clinic — Cleveland, Ohio, United States
• Medical University of South Carolina -Hollings Cancer Center MUSC — Charleston, South Carolina, United States
• University of Texas MD Anderson Cancer Center Dept of MD Anderson (16) — Houston, Texas, United States
• Novartis Investigative Site — Innsbruck, Austria
• Novartis Investigative Site — Vienna, Austria
• Novartis Investigative Site — Bruges, Belgium
• Novartis Investigative Site — Yvoir, Belgium
• Novartis Investigative Site — Edmonton, Alberta, Canada
• Novartis Investigative Site — Toronto, Ontario, Canada
• Novartis Investigative Site — Bobigny, France
• Novartis Investigative Site — Frankfurt, Germany
• Novartis Investigative Site — Freiburg im Breisgau, Germany
• Novartis Investigative Site — Budapest, Hungary
• Novartis Investigative Site — Debrecen, Hungary
• Novartis Investigative Site — Kaposvár, Hungary
• Novartis Investigative Site — Szeged, Hungary
• Novartis Investigative Site — Florence, FI, Italy
• Novartis Investigative Site — Reggio Calabria, RC, Italy
• Novartis Investigative Site — Roma, RM, Italy
• Novartis Investigative Site — Seoul, Korea, South Korea

Full record on ClinicalTrials.gov

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