Study of AEB071 (a Protein Kinase C Inhibitor) in Patients With CD79-mutant Diffuse Large B-Cell Lymphoma
NCT ID: NCT01402440
Last Updated: 2020-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
15 participants
INTERVENTIONAL
2011-11-30
2014-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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AEB071
AEB071
Interventions
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AEB071
Eligibility Criteria
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Inclusion Criteria
* Prior treatment and relapse following anthracycline-based chemotherapy and autologous bone marrow or stem cell transplant. Patients who are not transplant eligible may be considered for the study following a single regimen of chemotherapy such as R-CHOP or R-EPOCH alone. There is no limit to prior therapy allowed.
* Patients may be treated with localized radiation to as many as two sites of disease, so long as measurable or evaluable disease remains at untreated sites.
* Patients may be treated with corticosteriods immediately prior to enrollment and during the course of the study treatment as long as steriod treatment is tapered to a toal daily dosage of 10mg or less of prednisone (or it's equivalent) prior to AEB071 administration
* WHO performance status of ≤2
Exclusion Criteria
* Impaired cardiac function or clinically significant cardiac diseases, including any of the following:
* History or presence of ventricular tachyarrhythmia
* Angina pectoris or acute myocardial infarction ≤ 3 months prior to starting study drug
* Other clinically significant heart disease (e.g., symptomatic congestive heart failure; uncontrolled arrhythmia or hypertension; history of labile hypertension or poor compliance with an antihypertensive regimen)
* Patients with another malignancy that was treated within the last three years with the exceptions of localized basal cell carcinoma and cervical carcinoma.
* Patients with impairment of GI function or GI disease that could interfere with the absorption of AEB071.
* Patients with a known history of Human Immunodeficiency Virus (HIV)
* HIV testing is not required as part of this study
* Patients with a known history of active hepatitis B or C infection unless they are on antiviral therapy
* The determination of active hepatitis status should be as per standard of care at each site
* Hepatitis B and C testing is not required as part of this study
Time since the last prior therapy for treatment of underlying malignancy\*\*:
* Cytotoxic chemotherapy: ≤ than the duration of the most recent cycle of the previous regimen (with a minimum of 2 weeks for all)
* Biologic therapy (e.g., antibodies): ≤ 4 weeks
* ≤ 5 x t1/2 of a small molecule therapeutic, not otherwise defined above
\*\*Patients must have recovered or stabilized from all toxicities related to their previous treatment except for alopecia
* Patients with any history of significant coagulopathy or a medical condition requiring long term systemic anticoagulation that would interfere with biopsies.
* Patients having undergone major surgery less than 4 weeks prior to enrollment or that have not fully recovered from prior surgery.
* Pregnant or nursing (lactating) women
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Novarts Pharmaceuticals
Role: STUDY_DIRECTOR
Novarts Pharmaceuticals
Locations
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City of Hope National Medical Center
Duarte, California, United States
Washington University School of Medicine Div. of Medical Oncology
St Louis, Missouri, United States
Hackensack University Medical Center Hackensack (SC)
Hackensack, New Jersey, United States
Memorial Sloan Kettering Cancer Center MSK 2
New York, New York, United States
Ohio State Comprehensive Cancer Center/James Cancer Hospital Ohio State
Columbus, Ohio, United States
University of Texas/MD Anderson Cancer Center SC Location
Houston, Texas, United States
Novartis Investigative Site
Créteil, , France
Novartis Investigative Site
Lille, , France
Novartis Investigative Site
Pierre-Benite Cédex, , France
Novartis Investigative Site
Rouen, , France
Novartis Investigative Site
Berlin, , Germany
Novartis Investigative Site
München, , Germany
Novartis Investigative Site
Shatin, New Territories, Hong Kong, Hong Kong
Novartis Investigative Site
Milan, MI, Italy
Novartis Investigative Site
Torino, TO, Italy
Novartis Investigative Site
Amsterdam, , Netherlands
Novartis Investigative Site
Groningen, , Netherlands
Novartis Investigative Site
Rotterdam, , Netherlands
Novartis Investigative Site
Rotterdam, , Netherlands
Novartis Investigative Site
Seoul, Korea, South Korea
Novartis Investigative Site
Barcelona, Catalonia, Spain
Novartis Investigative Site
Barcelona, , Spain
Novartis Investigative Site
Taipei, , Taiwan
Novartis Investigative Site
Manchester, , United Kingdom
Countries
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Related Links
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Results for OEB071X2101 can be found on the Novartis Clinical Trial Results Website
Other Identifiers
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2010-024367-41
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
COEB071X2101
Identifier Type: -
Identifier Source: org_study_id