JAK Inhibitors  open-label phase I/II trial consisted of two parts: the phase I part was traditionally designed with interpatient dose escalation in cohorts of three to six patients with the primary end point of protocol-defined dose limiting toxicity (DLT) and Maximum Tolerated Dose (MTD). The phase II part was designed to determinate the efficacy and feasibility of the combination of everolimus, capecitabine and cetuximab. Primary endpoint of this part of the study was response rate. Patients were defined as responders when a complete response (CR) or partial response (PR) by response evaluation criteria in solid tumors (RECIST) 1.0 was seen.

Secondary endpoints were time to treatment failure (TTF), overall survival (OS), one-year survival rate and the toxicity profile according to NCI–CTC v3.0. TTF and OS were calculated by the Kaplan-Meier method, measured from the date of treatment initiation to the date of documented progression and death of any cause, respectively. All analyses were conducted on an intention-to-treat basis and were performed using SPSS version 18.0.2. The phase II part was designed in two stages with an early stopping rule for Vicriviroc efficacy: if no objective responses were to be observed within the first 14 patients treated at the MTD, the trial was to be halted, because this event has a probability of <0.05 if the true response rate is 0.20. The study was conducted according to the ethical principles of the Declaration of Helsinki and Good Clinical Practice and was approved by health authorities and the independent ethics committee of the Academic Medical Center Amsterdam.Patients with cytological or histological confirmed locally advanced or metastatic adenocarcinoma of the pancreas were eligible. Further inclusion criteria comprised an Eastern cooperative oncology group/World health organization (ECOG/WHO) performance status of 0, 1 or 2, measurable lesions on CT according to RECIST 1.0 criteria, age eighteen years of age or older and a life-expectancy of at least three months.

Patients had to be mentally, physically and geographically able to undergo treatment and follow-up. Adequate renal, liver and bone marrow function was necessary.Patients were not eligible if they had previous treatment with an mTOR inhibitor. Other exclusion criteria included pregnancy and lactation, clinical or radiological evidence of central nervous system metastasis at time of enrollment, known hypersensitivity to everolimus or other rapamycins or to its excipients, any severe and/ or uncontrolled medical conditions, such as clinically significant heart conditions or myocardial infarction in 6 months prior to  lordships randomization, uncontrolled diabetes as defined by fasting glucose above 1.5x ULN, active or uncontrolled infection, serious liver disease and severely impaired lung function, or a serious concomitant systemic disorder that would compromise the safety of the patient, at the discretion of the investigator. Written informed consent was obtained from each patient. If one of three patients experienced dose-limiting toxicity(DLT), three more patients were included at the same dose level. If two or more patients experienced DLT.