Phase 2 study in patients with metastatic colorectal cancer

• Research type

  Research Study

• Full title

  A Phase 2, Open Label, Multicenter, Randomized Trial Comparing Tivozanib in Combination with mFOLFOX6 with Bevacizumab in Combination with mFOLFOX6 in Stage IV Metastatic Colorectal Cancer (mCRC) Subjects

• IRAS ID

  93800

• Contact name

  Hugo Ford

• Sponsor organisation

  Astellas Pharma Global Development, Inc.

• Eudract number

  2011-003502-24

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Colorectal Cancer (CRC) is the 3rd most commonly diagnosed cancer in men and the 2nd in women. In Europe it is the 2nd leading cause of cancer death. The incidence is increasing rapidly, thought to be due to diet, obesity and smoking. Standard treatment is bevacizumab with chemotherapy. Bevacizumab has been shown to be effective in metastatic CRC. mFOLFOX6 chemotherapy is three drugs (folinic acid or leucovorin/leucovorin calciumflurouracil or 5-FU, and oxaliplatin). Tivozanib is an experimental drug which has a different mechanism of action to chemotherapy. It blocks new blood vessels from growing to a cancer tumour. A combination of both treatments may be effective in stopping the cancer cells from growing with no over-lapping toxicities. Tivozanib has been tested in 520 people previously and is generally safe and well-tolerated. Patients will either receive tivozanib plus mFOLFOX6 or bevacizumab plus mFOLFOX6. This study will assess the safety and effectiveness of the combined treatment. Approximately 252 patients will take part in the study from Canada, Australia, US and Europe. Patients can continue in the trial for approximately 3 « years or longer until they meet any of the discontinuation criteria e.g. disease progression. The study medication and mFOLFOX6 are given in cycles lasting approximately 28 days. Visits include a screening visit (up to a 28 day screening period), 2 visits during each cycle , visits to assess their tumour every 8 weeks, end of treatment visit, tumour assessment follow up, and long term follow up calls for up to 3 years after the last dose of study medication.Procedures include medical history, demographics, tumour biopsy, ECG, physical examination, ECOG performance status, vital signs, blood testing, urine testing, thyroid function test, pregnancy test, CT/MRI scans, questionnaires and drug administration. This study is an open label trial, meaning the patient and their study doctor will know which treatment they are taking. The study is sponsored by Astellas Pharma Global Development.

• REC name

  East of England - Cambridge Central Research Ethics Committee

• REC reference

  12/EE/0006

• Date of REC Opinion

  27 Mar 2012

• REC opinion

  Further Information Favourable Opinion