Phase II of RO5520985 in patients with metastatic colorectal cancer
Research type
Research Study
Full title
A PHASE II, MULTICENTER, RANDOMIZED,DOUBLE-BLIND STUDY TO EVALUATE THE EFFICACY AND SAFETY OF RO5520985 PLUS FOLFOX VERSUS BEVACIZUMAB PLUS FOLFOX IN PATIENTS WITH PREVIOUSLY UNTREATED METASTATIC COLORECTAL CANCER
IRAS ID
152575
Contact name
John Bridgewater
Contact email
Sponsor organisation
F. Hoffmann-La Roche Ltd
Eudract number
2013-005108-32
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
120910, IND No.
Research summary
RO5520985 is an investigational drug being developed by F.Hoffman-La Roche Ltd as a new treatment for metastatic Colorectal cancer (mCRC), a cancer with origins within the colon or the rectum. RO5520985 is an antibody designed to block two proteins resulting in inhibition/reduction of tumour growth.
RO5520985 has been previously tested in patients and is generally safe and well tolerated.
Part 1 of the study tests the safety and tolerability of RO5520985 in combination with chemotherapy (mFOLFOX-6). When this combination is found to be safe, the second part of the study can start. It compares the efficacy and safety of RO5520985 plus mFOLFOX-6 vs. a standard therapy (bevacizumab plus mFOLFOX-6) in a randomised (like tossing a coin) and double blind fashion (neither the doctor nor the participant will know which medication is being given).
Approximately 50 clinics in 9 countries will participate in this study. The UK will only participate in Part 2.
Around 140 patients with mCRC will be enrolled, approximately 22 participants in the UK.
The screening period will be up to 4 weeks. Study drugs will be administered fortnightly. Initial treatment will be either RO5520985 or bevacizumab (Avastin®) and mFOLFOX-6 for up to 8 cycles (around 4 months). Thereafter, participants will receive maintenance therapy for a maximum period of 24 months (the difference between induction and maintenance therapy is that patients will stop receiving oxaliplatin as part of the mFOLFOX-6 regimen). An end of study visit will be performed up to 6 weeks after the last dose of RO5520985. All patients will then be followed for survival and subsequent anticancer therapy every 3 months.
Study procedures include medical history, physical examination, vital signs, blood and urine sample collection, CT or MRI scans, ECG and cardiac review.REC name
London - London Bridge Research Ethics Committee
REC reference
14/LO/1476
Date of REC Opinion
3 Nov 2014
REC opinion
Further Information Favourable Opinion