A phase 1b/11 study of MEK162 and AMG479 in advanced solid tumours

• Research type

  Research Study

• Full title

  A phase Ib/11 open label multicentre study of the combination of MEK162 plus AMG 479 (ganitumab) in adult patients with selected advanced solid tumours

• IRAS ID

  104843

• Contact name

  Udai Banerji

• Sponsor organisation

  Novartis Pharma Services

• Eudract number

  2012-000305-76

• ISRCTN Number

  not issued

• Research summary

  The purpose of this open label, dose finding study is to estimate the Maximum tolerated dose(s) and/or to identify the recommended phase II dose(s) of MEK162 in combination with AMG 479 (ganitumab) in patients with advanced KRAS- or BRAF-mutant solid tumours. Within the proposed study, the dose expansion part of the study will be conducted in adult patients with advanced selected tumours to estimate the antitumour activity of MEK162 in combination with AMG 479 (ganitumab) in the following populations: ?½ Arm 1: Patients with KRAS-mutant colorectal adenocarcinoma. ?½ Arm 2: Patients with metastatic pancreatic adenocarcinoma ?½ Arm 3: Patients with mutant BRAFV600 melanoma cancers The trial is designed as a dose-escalation study which means the initial dose (s) given to patients will be low and will only be increased when 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 AMG 479 and MEK162 when given in combination.

• REC name

  London - Central Research Ethics Committee

• REC reference

  12/LO/0828

• Date of REC Opinion

  8 Jun 2012

• REC opinion

  Favourable Opinion