A Phase 1b/II study AEB071 and MEK162 in patients with uveal melanoma

• Research type

  Research Study

• Full title

  A phase Ib/II, open-label, multicenter study of AEB071 and MEK162 in adult patients with metastatic uveal melanoma

• IRAS ID

  132046

• Contact name

  James Larkin

• Contact email

  james.larkin@rmh.nhs.uk

• Sponsor organisation

  Novartis Pharma Services

• Eudract number

  2013-000281-11

• Research summary

  The purpose of this study is to determine the Maximum Tolerated Dose (MTD) of two experimental drugs, AEB071 and MEK162 that can be given in combination patients with uveal melanoma.
  The first part of the study will determine the maximum tolerated dose of AEB071 and MEK162 that can be given in combination. A group of patients (3 - 6 patients) will be given the MEK162 + AEB071 combination at a pre-defined safe dose from laboratory studies and closely monitored and any adverse events will be reported and taken into consideration during the dose escalation meeting (DEM). At the DEM if the
  decision is to dose escalate then further groups of patients will receive higher doses of MEK162 + AEB071 until the MTD is determined for the combination. At this point the dose expansion part of the study will open where
  further patients will receive either the MTD of MEK162 + AEB071 in combination or MEK162 alone.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  13/LO/1211

• Date of REC Opinion

  11 Oct 2013

• REC opinion

  Further Information Favourable Opinion