A phase 1 study of AEB071 in patients with metastatic uveal melanoma

• Research type

  Research Study

• Full title

  A phase 1 study of AEB071, an oral protein C kinase inhibitor, in patients with metastatic uveal melanoma.

• IRAS ID

  88663

• Contact name

  James Larkin

• Sponsor organisation

  Novartis Pharma Services

• Eudract number

  2011-002535-25

• ISRCTN Number

  n/a

• Research summary

  AEB071 has not been evaluated as an anticancer agent. It has however been evaluated in clinical studies as an immunosuppressive agent (in kidney and liver transplantation) and in autoimmune indications (psoriasis and ulcerative colitis). 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 immunosuppressant, or a different dosing regimen will be necessary for tumour control. Patients with uveal melanoma 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 regimens 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/1805

• Date of REC Opinion

  11 Jan 2012

• REC opinion

  Further Information Favourable Opinion