Masitinib/Placebo + Gemcitabine + FOLFIRI.3 in Pancreatic Cancer V1

• Research type

  Research Study

• Full title

  A prospective, multicentre, double-randomised, double-blind, 2-parallel groups, phase 3 study to compare as first line therapy efficacy and safety of masitinib in combination with gemcitabine, to gemcitabine in combination with placebo, followed as second line treatment by masitinib in combination with Florfiri.3 versus placebo in combination with Florfiri.3 in treatment of patients with non resectable locally advanced or metastatic pancreatic cancer.

• IRAS ID

  149612

• Contact name

  Tamas Hickish

• Contact email

  tamas.hickish@rbch.nhs.uk

• Sponsor organisation

  AB Science

• Eudract number

  2013-002293-41

• Research summary

  In diseases such as pancreatic cancer, enzymes that play a basic role in cell signal transmission do not function properly. Specific drugs like masitinib, can block malfunctioning enzymes and thus help to treat diseases that occur as a result of a fault in commination between cells.

  Masitinib is a new experimental drug, which is currently under clinical development to treat patients with various conditions.

  This phase 3 study will evaluate the efficacy and safety of masitinib in combination with gemcitabine, to gemcitabine in combination with placebo, followed as second line treatment by masitinib in combination with Florfiri 3 versus placebo in combination with Florfiri 3 in the treatment of patients with non respectable locally advanced or metastatic pancreatic cancer.

  The study will be carried out in 549 patients with metastatic pancreatic cancer. Patients will be randomly chosen to go into 2 groups:

  Group 1 patients will receive masitinib + gemcitabine at 1000mg/m2
  Group 2 patients will receive placebo + gemcitabine at 1000mg/m2

  330 patients will take part in a second randomisation.

  An estimated 220 patients previously treated by masitinib in combination with gemcitabine who were progressive, or non progressive and having discontinued study for any adverse event not defined as a severe adverse event due to the mechanism of action of masitinib will be randomised in two groups:

  Group 1A: Patients will receive masitinib+Folfiri.3
  Group 1B: Patients will receive placebo+Folfiri.3

  At second randomisation, patients will be centrally allocated to one of the two groups by IWRS according to modified minimisation method.

  An estimated 110 patients previously treated by placebo in combination with gemcitabine who were progressive or non progressive and having discontinued study for any adverse event not defined as severe adverse event due to the mechanism of action of masitinib will continue the study as:
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  Group 2: Patients will receive placebo+Folfiri.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  14/LO/1184

• Date of REC Opinion

  16 Sep 2014

• REC opinion

  Further Information Favourable Opinion