| Trial name or title |
An Exploratory Study of Treatment Sensitivity and Prognostic Factors in a Efficacy and Safety Study of mFOLFOX6 + Bevacizumab Versus mFOLFOX6 + Panitumumab Therapy in Patients With Chemotherapy‐naïve Unresectable Advanced or Recurrent Colorectal Cancer |
| Methods |
Phase III randomised controlled trial |
| Participants |
800 people with KRAS/NRAS WT mCRC |
| Interventions |
Experimental arm: mFOLFOX6 with panitumumab. Comparator: mFOLFOX6 with bevacizumab (5 mg/kg) |
| Outcomes |
Primary endpoint: OS and its correlation with each gene in baseline tumour samples. Secondary endpoints: PFS, response rate, duration of response, proportion of participants proceeding to surgical resection, proportion of participants with early tumour shrinkage, degree of maximum tumour shrinkage, evaluation of relationship of each biomarker in plasma free DNA and tumour samples from baseline or the main study, evaluation of the relationship between a change in each biomarker in plasma free DNA from baseline of the main study and efficacy, evaluation of the relationship between a change in each biomarker in plasma free DNA from baseline to discontinuation of the protocol treatment of the main study, and efficacy, evaluation of the relationship between a change in each biomarker in tumour tissue from baseline to discontinuation of the protocol treatment of the main study, and efficacy |
| Starting date |
May 2015 |
| Contact information |
Takeda Study Registration Call Center +1‐800‐778‐2860 (USA & EU) medicalinformation@tpna.com |
| Notes |
Sponsored by Takeda. Currently recruiting participants |
