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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

January 21, 2010
February 14, 2013
September 2009
February 2012   (final data collection date for primary outcome measure)
Incidence of dose limiting toxicity (DLT) [ Time Frame: 1 cycle (1 cycle = 28 days) ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01055483 on ClinicalTrials.gov Archive Site
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 ]
  • 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 ]
  • Rate of complete response [ Time Frame: After maximal three LBH589/chemotherapy cycles ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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
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

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).

Not Provided
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Acute Myeloid Leukemia
Drug: panobinostat/LBH589B
Experimental: LBH589
Intervention: Drug: panobinostat/LBH589B
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
59
February 2012
February 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France,   Germany
 
NCT01055483
CLBH589B2116, 2008-002986-30
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
February 2013

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