Efficacy and Safety of Panobinostat (LBH5789) in Patients With Refractory de Novo or Secondary Acute Myelogenous Leukemia (AML)

Acute Myelogenous Leukemia Clinical Trial

Official title:

A Phase II Study of Oral Single Agent Panobinostat in Patients With Refractory de Novo or Secondary Acute Myelogenous Leukemia (AML)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00880269
• Other study ID #: CLBH589B2213
• Secondary ID: 2008-002983-32
• Status: Completed
• Phase: Phase 2
• First received: March 30, 2009
• Last updated: April 18, 2013
• Start date: August 2009
• Est. completion date: February 2012

Study information

• Verified date: April 2013
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the efficacy and safety of single agent oral panobinostat in patients who have refractory de novo or refractory secondary AML.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Written informed consent prior to study-specific screening procedures

• Life expectancy of = 60 days

• Eastern Cooperative Group (ECOG) performance status = 2

• Refractory AML with confirmed initial diagnosis of de novo AML (excluding APL) - OR- Refractory AML with confirmed initial diagnosis of AML (excluding APL) secondary to AHD or MDS with either condition precedent to AML (MDS/AHD)

• Negative serum pregnancy test (within 7 days of first dose)

• Negative urine pregnancy test immediately prior to first dose

Exclusion Criteria:

• Known HIV

• Psychiatric disorder that interferes with ability to understand the study and give informed consent, and/or would impact study participation or follow-up

• Concurrent use of medications that might prolong the QT interval or of inducing Torsade de Pointes

• Female patients who are pregnant or breast-feeding or patients of childbearing potential who are not willing to use a double barrier method of contraception during the study and for 3 months following the last dose of study drug.

• Male patients whose sexual partner(s) are women of childbearing potential who are not willing to use a double method of contraception, one of which includes a condom, during the study and for 3 months after the end of treatment

• Patient is unable to swallow capsules

• Patients with impaired gastrointestinal systems which might cause interference with digesting and absorbing panobinostat

Other Protocol-defined inclusion/exclusion criteria may apply

Study Design

Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Myelogenous Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Refractory Leukemia

Intervention

Drug:
• Panobinostat/LBH589

Locations

Country	Name	City	State
Australia	Novartis Investigative Site	Adelaide	South Australia
Australia	Novartis Investigative Site	Gosford	New South Wales
Australia	Novartis Investigative Site	Herston	Queensland
Australia	Novartis Investigative Site	Melbourne	Victoria
Australia	Novartis Investigative Site	Prahran	Victoria
Belgium	Novartis Investigative Site	Brugge
Belgium	Novartis Investigative Site	Gent
Belgium	Novartis Investigative Site	Liege
France	Novartis Investigative Site	Bobigny Cedex
France	Novartis Investigative Site	Montpellier cedex 5
France	Novartis Investigative Site	Nantes
France	Novartis Investigative Site	Paris Cedex 4
France	Novartis Investigative Site	Toulouse cedex 9
Germany	Novartis Investigative Site	Frankfurt
Germany	Novartis Investigative Site	Köln
Germany	Novartis Investigative Site	Leipzig
Italy	Novartis Investigative Site	Roma	RM
Italy	Novartis Investigative Site	Roma	RM
Italy	Novartis Investigative Site	Udine	UD
Korea, Republic of	Novartis Investigative Site	Seoul
Peru	Novartis Investigative Site	Surquillo	Lima
Spain	Novartis Investigative Site	Barcelona	Cataluna
Spain	Novartis Investigative Site	Hospitalet de LLobregat	Catalunya
Switzerland	Novartis Investigative Site	Bern
Switzerland	Novartis Investigative Site	Zürich
Turkey	Novartis Investigative Site	Ankara
Turkey	Novartis Investigative Site	Izmir
United Kingdom	Novartis Investigative Site	Aberdeen	Scotland
United Kingdom	Novartis Investigative Site	Leeds
United Kingdom	Novartis Investigative Site	Liverpool
United Kingdom	Novartis Investigative Site	London
United Kingdom	Novartis Investigative Site	London
United States	University of Chicago Medical Center Dept. of U. of Chicago Hosp(3)	Chicago	Illinois
United States	University of Texas Southwestern Medical Center Dept of Simmons Cancer Center	Dallas	Texas
United States	MD Anderson Cancer Center/University of Texas Dept of MD Anderson (14)	Houston	Texas
United States	North Shore University Hospital North Shore Univ	Manhasset	New York
United States	Memorial Sloan Kettering Cancer Center Dept. of MSKCC (2)	New York	New York
United States	Methodist Cancer Center Nebraska Methodist Hospital(2)	Omaha	Nebraska
United States	Oregon Health Sciences University Dept. of OHSU (2)	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  France,  Germany,  Italy,  Korea, Republic of,  Peru,  Spain,  Switzerland,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CRR [complete remission rate (CR/CRi)]		June 2011	No
Secondary	To assess partial remission		June 2011	No
Secondary	Time to remission and duration of remission		June 2011	No
Secondary	Event-free survival		Jan 2012	No
Secondary	Overall survival		Jan 2012	No
Secondary	safety and tolerability		June 2011	No

External Links

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