AMG 479 and Gemcitabine in Metastatic Adenocarcinoma of the Pancreas
Research type
Research Study
Full title
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo Controlled, Trial of AMG 479 or Placebo in Combination with Gemcitabine as First-line Therapy for Metastatic Adenocarcinoma of the Pancreas
IRAS ID
64436
Sponsor organisation
Amgen Ltd
Eudract number
2010-020398-18
ISRCTN Number
N/A
Research summary
This is a phase 3, multicentre, 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) study. Subjects will be randomised in a 2:2:1 ratio to therapy consisting of 1 of 3 arms: Arm 1: AMG 479-placebo plus gemcitabine Arm 2: AMG 479 12 mg/kg plus gemcitabine Arm 3: AMG 479 20 mg/kg plus gemcitabine Each patient entering this study will have a 2/5 (40%) chance of receiving the placebo in addition to the chemotherapy and an overall 3/5 (60%) chance of receiving the study drug with the chemotherapy. Patients will continue to receive treatment until their cancer worsens/spreads, unacceptable side effects, withdrawal, or start of other new cancer treatment. Patients will have their tumours assessed using scans, every 8 weeks independent of the treatment cycle until their cancer worsens, withdrawal, or start of a new cancer treatment. 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 intensive AMG 479 and gemcitabine pharmacokinetic tests. Patients who stop treatment and their cancer has not worsened will continue having MRI/CT scans every 8 weeks until their cancer worsens, withdrawal of consent or start of a new cancer treatment.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
11/H0402/4
Date of REC Opinion
25 Feb 2011
REC opinion
Further Information Favourable Opinion