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Safety & Efficacy Study of Oral Panobinostat (LBH589) With Chemotherapy in Patients < 65 Years Old With Acute Myeloid Leukemia (AML)

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute Myeloid Leukemia (AML)

Intervention: Panobinostat (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Novartis Pharmaceuticals

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals

Summary

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.

Clinical Details

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)

Study design: Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Define the maximum tolerated dose of Panobinostat (LBH589) that can be given with standard idarubicin and ara-C chemotherapy measured by safety and tolerability.

Secondary outcome:

To determine the number of patients who have safety and tolerability events

To determine Panobinostat's pharmacokinetic parameters (study the amount of Panobinostat in a person's blood over time) following study treatments

To determine the response of Panobinostat (LBH589) given with standard idarubicin and ara-C chemotherapy (as defined by Cheson 2003)

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

Novartis Investigative Site, Dresden 01307, Germany

Novartis Investigative Site, Hannover 30625, Germany

Novartis Investigative Site, Ulm 89081, Germany

Novartis Investigative Site, Barcelona 08025, Spain

Stanford University Medical Center Stanford U, Stanford, California 94304, United States

Novartis Investigative Site, Salamanca, Castilla y Leon 37007, Spain

Dana Farber Cancer Institute Beth Israel Deaconess Med Ctr, Boston, Massachusetts 02115, United States

Ohio State Comprehensive Cancer Center/James Cancer Hospital Dept.ofJamesCancerHospital, Columbus, Ohio 43210, United States

Medical University of South Carolina -Hollings Cancer Center MUSC/HCC (2), Charleston, South Carolina 29425, United States

Vanderbilt University Medical Center, Clinical Trials Center Vanderbilt 3, Nashville, Tennessee 37212, United States

Additional Information

Starting date: October 2010
Last updated: May 5, 2015

Page last updated: August 23, 2015

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