MLN0264 in Adenocarcinoma of the Stomach or Gastroesophageal Junction
Research type
Research Study
Full title
A Phase 2 Trial of MLN0264 in Previously Treated Patients With Metastatic or Recurrent Adenocarcinoma of the Stomach or Gastroesophageal Junction Expressing Guanylyl Cyclase C (GCC) Protocol No:C26002
IRAS ID
149602
Contact name
Richard Hubner
Contact email
Sponsor organisation
Millennium Pharmaceuticals, Inc.
Eudract number
2014-000804-88
Clinicaltrials.gov Identifier
U1111-1155-9023, WHO Universal Trial Number (UTN)
Research summary
This is an open-label, non-randomised, multicenter, phase 2 study for male or female patients who are 18 years or older with adenocarcinoma (a cancer that develops in the glandular tissue) of the Stomach or Gastroesophageal Junction 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 (spread of cancer from one organ to another) disease.
Patients must have a sample of their tumor 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 main objective is to evaluate the overall response rate of patients treated with MLN0264.
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 will be included: physical examination, vital signs (Blood Pressure, Heart Rate and Temperature), height and weight, 12 lead electrocardiogram, patient questionnaires, computerised tomogrpahy (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/1143
Date of REC Opinion
15 Aug 2014
REC opinion
Favourable Opinion