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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
  Purpose

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 Intervention Phase
Acute Myeloid Leukemia (AML)
Drug: Panobinostat
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Novartis:

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. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 46
Study Start Date: October 2010
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: LBH589

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01242774

Locations
United States, California
Stanford University Medical Center Stanford U
Stanford, California, United States, 94304
United States, Massachusetts
Dana Farber Cancer Institute Beth Israel Deaconess Med Ctr
Boston, Massachusetts, United States, 02115
United States, Ohio
Ohio State Comprehensive Cancer Center/James Cancer Hospital Dept.ofJamesCancerHospital
Columbus, Ohio, United States, 43210
United States, South Carolina
Medical University of South Carolina -Hollings Cancer Center MUSC/HCC (2)
Charleston, South Carolina, United States, 29425
United States, Tennessee
Vanderbilt University Medical Center, Clinical Trials Center Vanderbilt 3
Nashville, Tennessee, United States, 37212
Germany
Novartis Investigative Site
Dresden, Germany, 01307
Novartis Investigative Site
Hannover, Germany, 30625
Novartis Investigative Site
Ulm, Germany, 89081
Spain
Novartis Investigative Site
Salamanca, Castilla y Leon, Spain, 37007
Novartis Investigative Site
Barcelona, Spain, 08025
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01242774     History of Changes
Other Study ID Numbers: CLBH589G2101, 2009-016809-42
Study First Received: October 17, 2010
Last Updated: September 16, 2014
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
Spain: Spanish Agency of Medicines

Keywords provided by Novartis:
AML
bone marrow
abnormal blast cells of myeloid
acute leukemia
cytogenetic abnormalities
HDACi

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms
Neoplasms by Histologic Type
Panobinostat
Antineoplastic Agents
Enzyme Inhibitors
Histone Deacetylase Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 23, 2014