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A Phase Ib, Open-label, Multi-center Dose-finding Study of Oral Panobinostat (LBH589) in Combination With Ara-C and Mitoxantrone as Salvage Therapy for Refractory or Relapsed Acute Myeloid Leukemia

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ClinicalTrials.gov Identifier: NCT01055483
Recruitment Status : Completed
First Posted : January 25, 2010
Last Update Posted : February 15, 2013
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
The study will determine the maximal tolerated dose (MTD) of panobinostat administered in combination with a fixed combination of cytarabine (ara-C) and mitoxantrone in adult patients with relapsed or refractory acute myeloid leukemia (AML).

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Drug: panobinostat/LBH589B Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase Ib, Open-label, Multi-center Dose-finding Study of Oral Panobinostat (LBH589) in Combination With Ara-C and Mitoxantrone as Salvage Therapy for Refractory or Relapsed Acute Myeloid Leukemia
Study Start Date : September 2009
Primary Completion Date : February 2012
Study Completion Date : February 2012


Arm Intervention/treatment
Experimental: LBH589 Drug: panobinostat/LBH589B



Primary Outcome Measures :
  1. Incidence of dose limiting toxicity (DLT) [ Time Frame: 1 cycle (1 cycle = 28 days) ]

Secondary Outcome Measures :
  1. Frequency, severity and duration of Adverse Events (AE) using CTCAE version 3.0 [ Time Frame: During maximal three LBH589/chemotherapy cycles and subsequent optional single-agent LBH589 treatment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with cytopathologically confirmed diagnosis of AML according to WHO criteria, excluding acute promyelocytic leukemia.
  • First relapsed AML
  • Primary refractory AML defined as failure to respond to initial induction chemotherapy (no CR) or recurrence within 6 months of initial CR.
  • Age more than 18 years
  • ECOG performance status < 2

Exclusion Criteria:

  • Prior treatment with deacetylase inhibitor
  • Concurrent therapy with any other investigational agent
  • Patients who have received cumulative doses (or its equivalent to other anthracyclines) of more than 360 mg/m2 of doxorubicin will be excluded from the study.
  • Clinical symptoms suggesting CNS leukemia
  • LVEF below 45% Other protocol-defined inclusion/exclusion criteria may apply

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01055483


Locations
France
Novartis Investigative Site
Paris Cedex 4, France, 75181
Novartis Investigative Site
Paris, France, 75475
Germany
Novartis Investigative Site
Dresden, Germany, 01307
Novartis Investigative Site
Frankfurt, Germany, 60590
Novartis Investigative Site
Hannover, Germany, 30625
Novartis Investigative Site
Ulm, Germany, 89081
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01055483     History of Changes
Other Study ID Numbers: CLBH589B2116
2008-002986-30 ( EudraCT Number )
First Posted: January 25, 2010    Key Record Dates
Last Update Posted: February 15, 2013
Last Verified: February 2013

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Acute myeloid leukemia
AML
relapsed acute myeloid leukemia
refractory acute myeloid leukemia

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Mitoxantrone
Panobinostat
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Histone Deacetylase Inhibitors