Safety and Efficacy of AEB071 and EVEROLIMUS in Patients With CD79-mutant or ABC Subtype Diffuse Large B-Cell Lymphoma
NCT01854606 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 31
Last updated 2020-12-19
Summary
Study of the safety and efficacy of AEB071 and EVEROLIMUS in patients with CD79-mutant or ABC subtype Diffuse Large B-Cell Lymphoma.
The trial did not progress into Phase II due to the suboptimal tolerability of the combination treatment of sotrastaurin and everolimus in the Phase Ib part of the study. There were no serious safety concerns associated with this combination.
Conditions
- CD79 Mutant or ABC-subtype Diffuse Large B-Cell Lymphoma
Interventions
- DRUG
-
AEB071
a Protein Kinase C Inhibitor
- DRUG
-
mTOR inhibitor
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Novartis Pharmaceuticals · Novartis Pharmaceuticals
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-12-05
- Primary Completion
- 2016-06-01
- Completion
- 2016-06-01
- FDA Drug
- Yes
Countries
- United States
- France
- Germany
- Hong Kong
- Italy
- Netherlands
- South Korea
- Taiwan
Study Locations
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