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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01055483
First received: January 21, 2010
Last updated: February 14, 2013
Last verified: February 2013
History of Changes
  Purpose

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 Intervention Phase
Acute Myeloid Leukemia
 Drug: panobinostat/LBH589B
 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Incidence of dose limiting toxicity (DLT) [ Time Frame: 1 cycle (1 cycle = 28 days) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 59
Study Start Date: September 2009
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LBH589 Drug: panobinostat/LBH589B

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01055483

Locations
France
Novartis Investigative Site
Paris, France, 75475
Novartis Investigative Site
Paris Cedex 4, France, 75181
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
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01055483     History of Changes
Other Study ID Numbers: CLBH589B2116, 2008-002986-30
Study First Received: January 21, 2010
Last Updated: February 14, 2013
Health Authority: United States: Food and Drug Administration
Germany: Bundesinstitut für Arzneimittel und Medizinprodukte
France: Agence Francaise de Securite Sanitaire des Produits de Sante

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

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms
Mitoxantrone
Antineoplastic Agents
 Therapeutic Uses
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 21, 2013