Statement: Abraxane + Capecitabine group of the primary trial has 61 more patients with either Complete Response (CR) disappearance of all target lesions; Partial Response (PR) at least a 30% decrease in the sum of the longest diameter of target lesions than the Abraxane Alone group.
Primary_evidence: Outcome Measurement:    Objective Response Rate   Patient response rates will be measured by the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI. Responses include the following: Complete Response (CR) disappearance of all target lesions; Partial Response (PR) at least a 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) best response from the start of treatment until disease progression.   Time frame: Baseline to 6 months Results 1:    Arm/Group Title: Abraxane + Tigatuzumab   Arm/Group Description: Patients will receive Abraxane at 100 mg/m2 X 3 doses on Days 1, 8, and 15 at 28-day intervals and tigatuzumab to be administered as a 10 mg/kg loading dose followed by 5 mg/kg for the first cycle and then every other week on Days 1 and 15 for subsequent cycles. Patients will be evaluated for response every 8 weeks. Patients with disease progression will be taken off the study.   Overall Number of Participants Analyzed: 39   Measure Type: Number   Unit of Measure: percentage of patients  28        (14.9 to 45.0) Results 2:    Arm/Group Title: Abraxane Alone   Arm/Group Description: Patients will receive Abraxane at 100 mg/m2 weekly X 3 doses on Days 1, 8, and 15 at 28-day intervals. Abraxane will be administered on an outpatient basis by an IV infusion over 30 minutes. Patients will be evaluated for response every 2 cycles (every 8 weeks).   Overall Number of Participants Analyzed: 21   Measure Type: Number   Unit of Measure: percentage of patients  38        (18 to 61.1)