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 Details
Study Description
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 |
---|---|---|
Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: LBH589
|
Drug: panobinostat/LBH589B
|
Outcome Measures
Primary Outcome Measures
- Incidence of dose limiting toxicity (DLT) [1 cycle (1 cycle = 28 days)]
Secondary Outcome Measures
- Frequency, severity and duration of Adverse Events (AE) using CTCAE version 3.0 [During maximal three LBH589/chemotherapy cycles and subsequent optional single-agent LBH589 treatment]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients with cytopathologically confirmed diagnosis of AML according to WHO criteria, excluding acute promyelocytic leukemia.
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First relapsed AML
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Primary refractory AML defined as failure to respond to initial induction chemotherapy (no CR) or recurrence within 6 months of initial CR.
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Age more than 18 years
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ECOG performance status < 2
Exclusion Criteria:
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Prior treatment with deacetylase inhibitor
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Concurrent therapy with any other investigational agent
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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.
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Clinical symptoms suggesting CNS leukemia
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LVEF below 45% Other protocol-defined inclusion/exclusion criteria may apply
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Novartis Investigative Site | Paris Cedex 4 | France | 75181 | |
2 | Novartis Investigative Site | Paris | France | 75475 | |
3 | Novartis Investigative Site | Dresden | Germany | 01307 | |
4 | Novartis Investigative Site | Frankfurt | Germany | 60590 | |
5 | Novartis Investigative Site | Hannover | Germany | 30625 | |
6 | Novartis Investigative Site | Ulm | Germany | 89081 |
Sponsors and Collaborators
- Novartis Pharmaceuticals
Investigators
- Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- CLBH589B2116
- 2008-002986-30