Spots Global Cancer Trial Database for Study of AEB071 (a Protein Kinase C Inhibitor) in Patients With CD79-mutant Diffuse Large B-Cell Lymphoma
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Trial Identification
Brief Title: Study of AEB071 (a Protein Kinase C Inhibitor) in Patients With CD79-mutant Diffuse Large B-Cell Lymphoma
Official Title: An Open-Label, Single-arm, Phase I Study of AEB071 (a Protein Kinase C Inhibitor) in Patients With CD79-mutant Diffuse Large B-Cell Lymphoma
Study ID: NCT01402440
Conditions
Interventions
Study Description
Brief Summary: This study has two phases, a dose escalation phase and a dose expansion phase. For dose escalation, the primary objective is to estimate the maximum tolerated dose of AEB071 in patients with diffuse large b-cell lymphoma. The endpoint for this objective will be occurrence of Dose Limiting Toxicity. For dose expansion, the primary objective is to characterize the safety and tolerability of the maximum tolerated dose or recommended phase 2 dose of AEB071 in patients with diffuse large b-cell lymphoma. The endpoints for this objective will be occurrence of Adverse Events (AEs), Serious Adverse Events (SAEs), assessment of clinical laboratory values, and vital sign measurements.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
City of Hope National Medical Center, Duarte, California, United States
Washington University School of Medicine Div. of Medical Oncology, Saint 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, Creteil, , France
Novartis Investigative Site, Lille Cedex, , France
Novartis Investigative Site, Pierre-Benite Cédex, , France
Novartis Investigative Site, Rouen Cedex 1, , France
Novartis Investigative Site, Berlin, , Germany
Novartis Investigative Site, Muenchen, , Germany
Novartis Investigative Site, Shatin, New Territories, , Hong Kong
Novartis Investigative Site, Milano, MI, Italy
Novartis Investigative Site, Torino, TO, Italy
Novartis Investigative Site, Seoul, Korea, Korea, Republic of
Novartis Investigative Site, Amsterdam, , Netherlands
Novartis Investigative Site, Groningen, , Netherlands
Novartis Investigative Site, Rotterdam, , Netherlands
Novartis Investigative Site, Rotterdam, , Netherlands
Novartis Investigative Site, Barcelona, Catalunya, Spain
Novartis Investigative Site, Barcelona, , Spain
Novartis Investigative Site, Taipei, , Taiwan
Novartis Investigative Site, Manchester, , United Kingdom
Contact Details
Name: Novartis Pharmaceuticals
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Name: Novarts Pharmaceuticals
Affiliation: Novarts Pharmaceuticals
Role: STUDY_DIRECTOR
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