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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01242774
First received: October 17, 2010
Last updated: September 16, 2014
Last verified: September 2014

October 17, 2010
September 16, 2014
October 2010
May 2014   (final data collection date for primary outcome measure)
Define the maximum tolerated dose of Panobinostat (LBH589) that can be given with standard idarubicin and ara-C chemotherapy measured by safety and tolerability. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01242774 on ClinicalTrials.gov Archive Site
  • To determine the number of patients who have safety and tolerability events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • To determine Panobinostat's pharmacokinetic parameters (study the amount of Panobinostat in a person's blood over time) following study treatments [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • To determine the response of Panobinostat (LBH589) given with standard idarubicin and ara-C chemotherapy (as defined by Cheson 2003) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Safety & Efficacy Study of Oral Panobinostat (LBH589) With Chemotherapy in Patients < 65 Years Old With Acute Myeloid Leukemia (AML)
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)

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Acute Myeloid Leukemia (AML)
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 Name: LBH589
Experimental: Panobinostat
Intervention: Drug: Panobinostat
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
46
May 2014
May 2014   (final data collection date for primary outcome measure)

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

Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Spain,   Germany
 
NCT01242774
CLBH589G2101, 2009-016809-42
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP