Phase II of gemcitabine with/without MSC1936369B

• Research type

  Research Study

• Full title

  Phase II randomized trial of MEKinhibitor MSC1936369B or placebo combined with gemcitabine in metastatic pancreas cancer subjects

• IRAS ID

  104776

• Contact name

  John Bridgewater

• Sponsor organisation

  Merck Serono S.A. - Geneva

• Eudract number

  2009-011992-61

• ISRCTN Number

  n/a

• Research summary

  This is a two-part trial, randomised double-bind, comparative Phase II trial of gemcitabine (anticancer drug) placebo and gemcitabine MSC1936369B. MSC1936369B is an experimental drug meaning the study drug is not approved by health authorities and is still being tested for safety and effectiveness. This will be carried out on male and female subjects =18 years with metastatic pancreatic cancer (when the cancer has spread outside of the pancreas). The main trial will also include additional pharmacogenetic (PGx)research, that will look at genetic reasons why certain people respond differently to drugs. This trial is planned to take part in 5 UK Medical Centers. A total of 61 subjects per treatment arm (122 subjects in total) will be randomized in the Phase II part of the trial, assuming constant recruitment lasting for 12 months and a maximum Phase II trial duration of 18 months. Subjects will be randomised in a ratio of 1:1 to receive either gemcitabine and placebo(Arm 1) or gemcitabine combined with MSC1936369B (Arm 2). Subjects failing treatment in Arm 1 will be proposed to receive subsequent MSC1936369B as monotherapy. Monotherapy is when the drug will be taken by itself.

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  12/LO/0951

• Date of REC Opinion

  24 Aug 2012

• REC opinion

  Further Information Favourable Opinion