Safety & Efficacy Study of Oral Panobinostat (LBH589) With Chemotherapy in Patients < 65 Years Old With Acute Myeloid Leukemia (AML)
This study is currently recruiting participants.
Verified March 2013 by Novartis
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01242774
First received: October 17, 2010
Last updated: March 1, 2013
Last verified: March 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Myeloid Leukemia (AML) |
Drug: Panobinostat |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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) |
Resource links provided by NLM:
Genetics Home Reference related topics:
familial acute myeloid leukemia with mutated CEBPA
tetrasomy 18p
Drug Information available for:
Cytarabine
U.S. FDA Resources
Further study details as provided by Novartis:
Primary Outcome Measures:
- Define the maximum tolerated dose of Panobinostat (LBH589) that can be given with standard idarubicin and ara-C chemotherapy measured by safety and tolerability. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To determine the number of patients who have safety and tolerability events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- To determine Panobinostat's pharmacokinetic parameters (study the amount of Panobinostat in a person's blood over time) following study treatments [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- To determine the response of Panobinostat (LBH589) given with standard idarubicin and ara-C chemotherapy (as defined by Cheson 2003) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 44 |
| Study Start Date: | October 2010 |
| Estimated Study Completion Date: | May 2015 |
| Estimated Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Panobinostat |
Drug: Panobinostat
Oral administration 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.
Other Name: LBH589
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01242774
Contacts
| Contact: Novartis Pharmaceuticals | 1-888-669-6682 | |
| Contact: Novartis Pharmaceuticals |
Locations
| United States, California | |
| Stanford University Medical Center Stanford U | Recruiting |
| Stanford, California, United States, 94304 | |
| Contact: Marlene Zuraek 650-736-4031 marlenez@stanford.edu | |
| Principal Investigator: Bruno Medeiros | |
| United States, Massachusetts | |
| Dana Farber Cancer Institute Ctr. for Hematologic Oncology | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Sara Guterman 617-632-2645 sguterman@partners.org | |
| Principal Investigator: Daniel J. DeAngelo | |
| United States, Ohio | |
| Ohio State Comprehensive Cancer Center/James Cancer Hospital Dept.ofJamesCancerHospital | Recruiting |
| Columbus, Ohio, United States, 43210 | |
| Contact: Kristy Culler 614-293-2268 kristy.culler@osumc.edu | |
| Principal Investigator: Alison Walker | |
| United States, South Carolina | |
| Medical University of South Carolina MUSC/HCC (2) | Recruiting |
| Charleston, South Carolina, United States, 29425 | |
| Contact: Jessica Simons 843-792-9756 simonsjl@musc.edu | |
| Principal Investigator: Robert K. Stuart | |
| United States, Tennessee | |
| Vanderbilt University Medical Center, Clinical Trials Center Vanderbilt 3 | Recruiting |
| Nashville, Tennessee, United States, 37212 | |
| Contact: Tanya Davis 615-936-5173 Tanya.e.davis@vanderbilt.edu | |
| Principal Investigator: Stephen Strickland | |
| United States, Texas | |
| MD Anderson Cancer Center/University of Texas Dept of MD Anderson (15) | Withdrawn |
| Houston, Texas, United States, 77030-4009 | |
| Germany | |
| Novartis Investigative Site | Recruiting |
| Dresden, Germany, 01307 | |
| Novartis Investigative Site | Recruiting |
| Frankfurt, Germany, 60590 | |
| Novartis Investigative Site | Recruiting |
| Hannover, Germany, 30625 | |
| Novartis Investigative Site | Recruiting |
| Ulm, Germany, 89081 | |
| Hong Kong | |
| Novartis Investigative Site | Withdrawn |
| New Territories, Hong Kong | |
| Spain | |
| Novartis Investigative Site | Recruiting |
| Salamanca, Castilla y Leon, Spain, 37007 | |
| Novartis Investigative Site | Recruiting |
| Barcelona, Cataluna, Spain, 08025 | |
| Novartis Investigative Site | Recruiting |
| Valencia, Spain, 46026 | |
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: | NCT01242774 History of Changes |
| Other Study ID Numbers: | CLBH589G2101, 2009-016809-42 |
| Study First Received: | October 17, 2010 |
| Last Updated: | March 1, 2013 |
| Health Authority: | United States: Food and Drug Administration Germany: Federal Institute for Drugs and Medical Devices Spain: Spanish Agency of Medicines |
Keywords provided by Novartis:
|
AML bone marrow abnormal blast cells of myeloid |
acute leukemia cytogenetic abnormalities HDACi |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Myeloid, Acute Leukemia, Myeloid Neoplasms by Histologic Type Neoplasms Cytarabine Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 17, 2013