AMG 479 and Gemcitabine in locally advanced Pancreatic Cancer

• Research type

  Research Study

• Full title

  A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Trial of AMG 479 or Placebo in Combination with Gemcitabine as First-line Therapy for Locally Advanced Unresectable Adenocarcinoma of the Pancreas

• IRAS ID

  76441

• Contact name

  David Cunningham

• Sponsor organisation

  Amgen Inc

• Eudract number

  2010-023978-39

• Clinicaltrials.gov Identifier

  NCT01318642

• Research summary

  The primary purpose of this study is to find out if treatment with AMG 479 in combination with gemcitabine (a chemotherapy) has an effect on progression-free survival compared with placebo in combination with gemcitabine, in patients with locally advanced pancreatic cancer. This is a phase 2, multicenter, randomized (groups selected by a computer by chance), double-blind (neither the patient nor the doctor will know the treatment group), placebo controlled (dummy treatment), two-arm trial of AMG 479 or placebo in combination with gemcitabine as first-line therapy for locally advanced pancreatic cancer. Approximately 150 subjects will be randomized 1:1 to AMG 479 or placebo (AMG 479-placebo) in combination with gemcitabine as follows: Arm 1: AMG 479 plus gemcitabine Arm 2: AMG 479-Placebo plus gemcitabine Each patient entering the study will have a 1 in 2 (50%) chance of receiving the study product in addition to the chemotherapy and an overall 1 in 2 (50%) chance of receiving the placebo with the chemotherapy. Cycles of chemotherapy plus AMG 479 or placebo are planned to be administered every 28 days. Study treatment will be administered on days 1 and 15 of each cycle. Subjects will continue to receive AMG 479 plus gemcitabine or AMG 479-placebo plus gemcitabine until disease progression, unacceptable toxicities, withdrawal of consent, or start of a new cancer treatment. Patients will have their tumours assessed using scans every 8 weeks independent of the treatment cycle until disease progression or withdrawal of consent. All patients will be assessed for non-intensive AMG 479 pharmacokinetics (to test how much drug is in the body at any time). Approximately thirteen patients per arm will be assessed for more intensive AMG 479 and gemcitabine pharmacokinetic tests.

• REC name

  Scotland A REC

• REC reference

  12/SS/0045

• Date of REC Opinion

  17 Apr 2012

• REC opinion

  Further Information Favourable Opinion