EZN-2208 (PEG-SN38) Study in Metastatic Colorectal Carcinoma
Research type
Research Study
Full title
A Phase 2 Study of EZN-2208(PEG-SN38) Administered With or Without Cetuximab in Patients with Metastatic Colorectal Carcimoma (mCRC)
IRAS ID
58515
Sponsor organisation
Enzon Pharmaceuticals Inc
Eudract number
2009-014876-23
Clinicaltrials.gov Identifier
Research summary
This is a Phase 2 multicentre, open label study with two treatment arms, designed to assess the effectiveness, safety and tolerability of EZN-2208 in the treatment of metastatic colorectal carcinomas. Subjects will initially be consented and then have their tumour tested to assess whether their gene is wild type or mutated. Subjects will then be randomised to receive either EZN-2208 Cetuximab (Arm B) or the current standard treatment of Cetuximab Irinotecan (Arm C). Subjects will be seen at screen and then seen weekly for treatment and safety assessments to be performed. Subjects randomised to Arm B will be treated in 4 weekly cycles - EZN-2208 Cetuximab will be given once a week for three weeks followed by a further dose of Cetuximab on Week 4. Subjects in Arm C will be seen on a 3 weekly cycle - Cetuximab Irinotecan will be given once a week for three weeks. Treatment cycles will continue until subject's tumour progresses or they experience intolerable side effects. This is anticipated as an average of 16 weeks. Following completion subjects will be seen in the post treatment follow up phase every three months for at least 6 months where information regarding survival, disease progression and anti cancer therapies commenced since study end will be collected This study also includes sub studies to which subjects will be asked to consent to separately. If subjects agree to the sub study blood will be taken to perform PBMC genotyping and a sample of tissue from the original biopsy used to make the diagnosis will be tested for biomarkers.
REC name
East of England - Essex Research Ethics Committee
REC reference
10/H0301/46
Date of REC Opinion
25 Oct 2010
REC opinion
Further Information Favourable Opinion