MLN0264 in Pancreatic Adenocarcinoma
Research type
Research Study
Full title
A Phase 2 Trial of MLN0264 in Previously Treated Patients With Advanced or Metastatic Pancreatic Adenocarcinoma Expressing Guanylyl Cyclase C (GCC) Protocol No:C26003
IRAS ID
159053
Contact name
Richard Hubner
Contact email
Sponsor organisation
Millennium Pharmaceuticals, Inc.
Eudract number
2014-000805-11
Clinicaltrials.gov Identifier
U1111-1155-8964, WHO Universal Trial Number (UTN)
Research summary
This is an open-label, non-randomised, multicenter, phase 2 study for male or female patients 18 years of age or older with advanced or metastatic adenocarcinoma(a cancer that develops in the glandular tissue) of the pancreas expressing guanylyl cyclase C (GCC) who have an Eastern Cooperative Oncology Group performance status of 0 or 1; who have been treated with 1 or more prior chemotherapies for advanced or metastatic disease(spread of cancer from one organ to another).
Patients must have a sample of their tumour tissue tested for the presence of a protein called GCC. This testing will be done on stored tumour tissue from a prior biopsy or from a fresh biopsy. Patients must have positive GCC test to be enrolled.
Patients will receive 1.8 mg/kg MLN0264 (study drug) by intra-venous infusion on Day 1 of 3-week cycles for up to 1 year or until disease progression or unacceptable toxicity occurs. MLN0264 is an investigational drug which is made of
a monoclonal antibody linked to a cytotoxic (cell-killing) agent. The term "monoclonal" refers to the fact that it is produced in a laboratory.Approximately 42-81 patient will be enrolled from 35 sites in 7 countries.
The study duration is approximately 3.5 years, including 24 months of enrollment and 6 additional months of follow-up for each patient.
The study has 4 sections Screening (up to 21 days), Treatment (up to 17 cycles/1 year), End of Treatment (30 days post last study drug) and approximately 6 month Follow-Up.
The following assessments will be included: physical examination, vital signs (Blood Pressure, Heart Rate and Temperature), height and weight, 12 lead electrocardiogram (heart tracing), patient questionnaires, computerised tomograpahy (CT)and/or magnetic resonance imaging (MRI) scans, blood, urine tests, buccal (cheek) swab and tumour biopsies.
REC name
North West - Haydock Research Ethics Committee
REC reference
14/NW/1144
Date of REC Opinion
15 Aug 2014
REC opinion
Favourable Opinion