A phase 1 study of AEB071 in patients with CD79 mutant lymphoma

• Research type

  Research Study

• Full 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)

• IRAS ID

  82346

• Contact name

  John Radford

• Sponsor organisation

  Novartis Pharma Services

• Eudract number

  2010-024367-41

• ISRCTN Number

  n/a

• Research summary

  AEB071 has not been evaluated as an anti-cancer agent. It has however been evaluated in clinical studies as an immunosuppressive agent (in kidney and liver transplantion) and in autoimmune indications (psoriasis and ulcerative colitis). To ensure that lymphoma patients with the relevant CD79 mutations are included in the study, molecular pre-screening must be performed on archival or freshly obtained tumour samples. After a mutation is confirmed during molecular pre-screening, potentially eligible patients will undergo informed consent and screening assessments to ensure that they are eligible to enter the study.The study is comprised of a dose escalation phase and a dose expansion phase and is an open label study which means that everyone participating will receive AEB071.AEB071 is an oral tablet that patients will take every day on a 28 day cycle. Preclinical data suggest that doses of AEB071 higher than those currently being used for immunosuppression, or a different dosing regimen will be necessary for tumour control. Patients with lymphoma may have differing sensitivities to the toxicities of AEB071 compared with the patient populations treated to date therefore, a Phase I design with dose escalation was chosen for this trial. The starting dose will be 300 mg twice daily, the most extensively used multiple dose regimen in prior studies.The trial is designed as a dose-escalation study which means the initial dose given to patients will be low and will only be increased when it has been assessed to be safe.Once the maximum tolerated dose is reached the expansion part of the study will be opened to recruitment. Patients will be treated at a single dose level to further assess the safety and tolerability of AEB071.

• REC name

  London - Hampstead Research Ethics Committee

• REC reference

  11/LO/1293

• Date of REC Opinion

  6 Oct 2011

• REC opinion

  Further Information Favourable Opinion