Phase 2 Veliparib or Placebo, plus FOLFIRI ± Bevacizumab in mCRC
Research type
Research Study
Full title
Randomized, Double-Blind, Multicenter, Phase 2 Study Comparing Veliparib Plus FOLFIRI ± Bevacizumab Versus Placebo Plus FOLFIRI ± Bevacizumab in Previously Untreated Metastatic Colorectal Cancer
IRAS ID
161809
Contact name
Georgina Walker
Contact email
Sponsor organisation
AbbVie Ltd
Eudract number
2014-002866-65
Duration of Study in the UK
2 years, 2 months, 27 days
Research summary
Colorectal cancer is the third most common cancer in men and the second most common in women with 746,000 and 614,000 cases respectively worldwide in 2012. Metastatic (cancer that has spread) colorectal cancer (mCRC) is a largely incurable disease. The majority of patients diagnosed with mCRC have secondary tumors in their liver or lungs. Current approved chemotherapy drug treatment options include FOLFIRI and FOLFOX . These combination chemotherapy treatments may be used with bevacizumab (Avastin), which inhibits the growth of new blood vessels around tumors. These treatments significantly improve quality and duration of life, but only 6% of patients live to 5 years after diagnosis of mCRC.
Veliparib is a “PARP inhibitor” that may improve chemotherapy. It works by blocking tumour cells from repairing DNA-damage caused by chemotherapy, ultimately killing cancer cells.
In this study patients will receive FOLFIRI (±bevacizumab) and veliparib or placebo (substance that looks the same as veliparib but has no active ingredients). Half of the patients will receive veliparib, and half placebo. The trial will look at which treatment is better at controlling the cancer by measuring overall survival and progression-free time. This is a phase II, randomised, blinded trial – neither the patient nor the doctor knows whether the patient is taking veliparib or placebo.
Patients could benefit if tumour growth is inhibited, improving their condition and survival time. Information gathered may help improve future treatment of this disease.
Patients will attend regular study visits at hospital until the treatment is no longer effective (10-15 months on average). The effect of the treatments on the cancer will be monitored by scans, blood tests and checking for side effects. There are additional blood tests to see why some people respond better than others and how long the drug remains in the body and an optional genetics test.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
14/EM/1314
Date of REC Opinion
2 Feb 2015
REC opinion
Further Information Favourable Opinion