Acute Myelogenous Leukemia Clinical Trial
Official title:
A Phase II Study of Oral Single Agent Panobinostat in Patients With Refractory de Novo or Secondary Acute Myelogenous Leukemia (AML)
Verified date | April 2013 |
Source | Novartis |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
This study will evaluate the efficacy and safety of single agent oral panobinostat in patients who have refractory de novo or refractory secondary AML.
Status | Completed |
Enrollment | 88 |
Est. completion date | February 2012 |
Est. primary completion date | February 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 85 Years |
Eligibility |
Inclusion Criteria: - Written informed consent prior to study-specific screening procedures - Life expectancy of = 60 days - Eastern Cooperative Group (ECOG) performance status = 2 - Refractory AML with confirmed initial diagnosis of de novo AML (excluding APL) - OR- Refractory AML with confirmed initial diagnosis of AML (excluding APL) secondary to AHD or MDS with either condition precedent to AML (MDS/AHD) - Negative serum pregnancy test (within 7 days of first dose) - Negative urine pregnancy test immediately prior to first dose Exclusion Criteria: - Known HIV - Psychiatric disorder that interferes with ability to understand the study and give informed consent, and/or would impact study participation or follow-up - Concurrent use of medications that might prolong the QT interval or of inducing Torsade de Pointes - Female patients who are pregnant or breast-feeding or patients of childbearing potential who are not willing to use a double barrier method of contraception during the study and for 3 months following the last dose of study drug. - Male patients whose sexual partner(s) are women of childbearing potential who are not willing to use a double method of contraception, one of which includes a condom, during the study and for 3 months after the end of treatment - Patient is unable to swallow capsules - Patients with impaired gastrointestinal systems which might cause interference with digesting and absorbing panobinostat Other Protocol-defined inclusion/exclusion criteria may apply |
Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Australia | Novartis Investigative Site | Adelaide | South Australia |
Australia | Novartis Investigative Site | Gosford | New South Wales |
Australia | Novartis Investigative Site | Herston | Queensland |
Australia | Novartis Investigative Site | Melbourne | Victoria |
Australia | Novartis Investigative Site | Prahran | Victoria |
Belgium | Novartis Investigative Site | Brugge | |
Belgium | Novartis Investigative Site | Gent | |
Belgium | Novartis Investigative Site | Liege | |
France | Novartis Investigative Site | Bobigny Cedex | |
France | Novartis Investigative Site | Montpellier cedex 5 | |
France | Novartis Investigative Site | Nantes | |
France | Novartis Investigative Site | Paris Cedex 4 | |
France | Novartis Investigative Site | Toulouse cedex 9 | |
Germany | Novartis Investigative Site | Frankfurt | |
Germany | Novartis Investigative Site | Köln | |
Germany | Novartis Investigative Site | Leipzig | |
Italy | Novartis Investigative Site | Roma | RM |
Italy | Novartis Investigative Site | Roma | RM |
Italy | Novartis Investigative Site | Udine | UD |
Korea, Republic of | Novartis Investigative Site | Seoul | |
Peru | Novartis Investigative Site | Surquillo | Lima |
Spain | Novartis Investigative Site | Barcelona | Cataluna |
Spain | Novartis Investigative Site | Hospitalet de LLobregat | Catalunya |
Switzerland | Novartis Investigative Site | Bern | |
Switzerland | Novartis Investigative Site | Zürich | |
Turkey | Novartis Investigative Site | Ankara | |
Turkey | Novartis Investigative Site | Izmir | |
United Kingdom | Novartis Investigative Site | Aberdeen | Scotland |
United Kingdom | Novartis Investigative Site | Leeds | |
United Kingdom | Novartis Investigative Site | Liverpool | |
United Kingdom | Novartis Investigative Site | London | |
United Kingdom | Novartis Investigative Site | London | |
United States | University of Chicago Medical Center Dept. of U. of Chicago Hosp(3) | Chicago | Illinois |
United States | University of Texas Southwestern Medical Center Dept of Simmons Cancer Center | Dallas | Texas |
United States | MD Anderson Cancer Center/University of Texas Dept of MD Anderson (14) | Houston | Texas |
United States | North Shore University Hospital North Shore Univ | Manhasset | New York |
United States | Memorial Sloan Kettering Cancer Center Dept. of MSKCC (2) | New York | New York |
United States | Methodist Cancer Center Nebraska Methodist Hospital(2) | Omaha | Nebraska |
United States | Oregon Health Sciences University Dept. of OHSU (2) | Portland | Oregon |
Lead Sponsor | Collaborator |
---|---|
Novartis Pharmaceuticals |
United States, Australia, Belgium, France, Germany, Italy, Korea, Republic of, Peru, Spain, Switzerland, Turkey, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | CRR [complete remission rate (CR/CRi)] | June 2011 | No | |
Secondary | To assess partial remission | June 2011 | No | |
Secondary | Time to remission and duration of remission | June 2011 | No | |
Secondary | Event-free survival | Jan 2012 | No | |
Secondary | Overall survival | Jan 2012 | No | |
Secondary | safety and tolerability | June 2011 | No |
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