Safety & Efficacy Study of Oral Panobinostat (LBH589) With Chemotherapy in Patients < 65 Years Old With Acute Myeloid Leukemia (AML)

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT01242774

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

4.6

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will be conducted to assess the maximum tolerated dose (MTD) of panobinostat given 3 times a week (administered on weeks 2 and 3 of a 4 week cycle) in combination with induction chemotherapy (idarubicin and cytarabine) in newly diagnosed patients with a cytopathologically confirmed diagnosis of high-risk AML, and to investigate the safety of the combination in this regimen.

Condition or Disease	Intervention/Treatment	Phase
Acute Myeloid Leukemia (AML)	Drug: Panobinostat	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

46 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase Ib, Dose-finding Study of Oral Panobinostat (LBH589) in Combination With Idarubicin and Cytarabine Induction and High-dose Cytarabine-based Consolidation Therapy in Adult Patients Less Than or Equal to 65 Years Old With Acute Myeloid Leukemia (AML)

Study Start Date :

Oct 1, 2010

Actual Primary Completion Date :

May 1, 2014

Actual Study Completion Date :

May 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Panobinostat	Drug: Panobinostat Oral administration of panobinostat given 3 times a week (administered on weeks 2 and 3 of a 4 week cycle) in combination with induction chemotherapy (idarubicin and cytarabine. Other Names: LBH589

Arm

Intervention/Treatment

Experimental: Panobinostat

Drug: Panobinostat

Oral administration of panobinostat given 3 times a week (administered on weeks 2 and 3 of a 4 week cycle) in combination with induction chemotherapy (idarubicin and cytarabine.

Other Names:

LBH589

Outcome Measures

Primary Outcome Measures

Define the maximum tolerated dose of Panobinostat (LBH589) that can be given with standard idarubicin and ara-C chemotherapy measured by safety and tolerability. [1 year]

Secondary Outcome Measures

To determine the number of patients who have safety and tolerability events [1 year]
To determine Panobinostat's pharmacokinetic parameters (study the amount of Panobinostat in a person's blood over time) following study treatments [1 year]
To determine the response of Panobinostat (LBH589) given with standard idarubicin and ara-C chemotherapy (as defined by Cheson 2003) [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Newly diagnosed adult patients = 65 years old with a cytopathologically confirmed diagnosis of high-risk AML
= 20% bone marrow blasts via bone marrow aspiration or biopsy
The patient has not yet been treated for AML
1º or 2º AML patients with high-risk category features
ECOG PS = 2
Renal function and liver function limits.

Exclusion Criteria:

Patient with a 'favorable' or 'better-risk' cytogenetic profile = t(15;17); t(8;21); or inv(16) or t(16;16)
Patient has clinical symptoms suggestive of CNS leukemia and/or CSF findings for CNS leukemia
Prior treatment with deacetylase inhibitors (DACi) including, panobinostat
Impaired cardiac function
Female patient who is pregnant or breast feeding
Male patient who is not willing to use a barrier method of contraception

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University Medical Center Stanford U	Stanford	California	United States	94304
2	Dana Farber Cancer Institute Beth Israel Deaconess Med Ctr	Boston	Massachusetts	United States	02115
3	Ohio State Comprehensive Cancer Center/James Cancer Hospital Dept.ofJamesCancerHospital	Columbus	Ohio	United States	43210
4	Medical University of South Carolina -Hollings Cancer Center MUSC/HCC (2)	Charleston	South Carolina	United States	29425
5	Vanderbilt University Medical Center, Clinical Trials Center Vanderbilt 3	Nashville	Tennessee	United States	37212
6	Novartis Investigative Site	Dresden		Germany	01307
7	Novartis Investigative Site	Hannover		Germany	30625
8	Novartis Investigative Site	Ulm		Germany	89081
9	Novartis Investigative Site	Salamanca	Castilla Y Leon	Spain	37007
10	Novartis Investigative Site	Barcelona		Spain	08025