Statement: the primary trial and the secondary trial use Maximum Tolerated Dose Determined by Dose-limiting Toxicities as their outcome measurements.
Primary_evidence: Outcome Measurement:    Ruxolitinib Maximum Tolerated Dose (MTD) [Phase I]   Ruxolitinib MTD in combination with paclitaxel 80 mg/m2 intravenously (IV) weekly is determined by the number of patients who have dose limiting toxicity (DLT). See DLT primary outcome measure for definition   If a DLT was observed in 0 of 3 patients in a cohort, then 3 patients were enrolled to the next cohort using a 5mg higher dose of ruxolitinib.   If a DLT was observed in 1 of 3 patients in a cohort, then 3 additional patients were added, and then if no further DLTs were observed, 3 patients were enrolled to the next cohort using a 5mg higher dose of ruxolitinib.   The MTD is identified as the level BELOW the cohort where DLT occurred in less than one third of patients within the cohort.   If no DLT's are observed, the MTD is not reached.   Time frame: Participants were assessed prior to each dose of paclitaxel with ruxolitinib; The observation period for MTD evaluation was the first 2 cycles of treatment. (Up to 8 weeks). Results 1:    Arm/Group Title: All Phase I Participants   Arm/Group Description: Paclitaxel 80 mg/m2 IV weekly + Ruxolitinib orally twice daily according to the established dose escalation schedule for 4 cycles   1 cycle = 21 days Participants with stable disease or better will have the opportunity to continue on single agent Ruxolitinib at the established dose until disease progression, unacceptable toxicity or patient withdrawal.   Overall Number of Participants Analyzed: 18   Measure Type: Number   Unit of Measure: mg  15
Secondary_evidence: Outcome Measurement:    Maximum Tolerated Dose Determined by Dose-limiting Toxicities   1st 3 pts will be treated on arm 2. If 0/3 DLTs observed, the dose will be escalated to arm 3. If 1/3 DLTs onserved on arm 2, 3 more pts will be treated on arm 2. If no additional DLTs are observed on arm 2, the dose will be escalated to arm 3. If at most 1/6 DLTs observed on arm 3, arm 3 will be considered the MTD. If more than 1/6 DLTs observed on arm 3, the dose will be de-escalated to arm 2. If at most 1/6 DLTs observed on arm 2, arm 2 will be considered the MTD. If more than 1/6 pts on arm 2 experience a DLT, the dose will be de-escalated to arm 1. The remaining pts will be treated on arm 1 as the MTD, unless more than 1/6 DLTs, in which case the study will stop. DLT is defined as any grade III or IV non-hematologic toxicity (incl. diarrhea w\ adequate antidiarrheal treatment & hydration & nausea/vomiting w\ maximal antiemetic prophylaxis, as per protocol) or grade IV hematologic toxicity. DLT will be based on the 1st course of treatment according to the revised NCI CTC v 2.0   Time frame: 21 days Results 1:    Arm/Group Title: Arm 1   Arm/Group Description: Capecitabine 800 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,   Overall Number of Participants Analyzed: 0   Measure Type: Number   Unit of Measure: Patients experiencing DLT   Results 2:    Arm/Group Title: Arm 2   Arm/Group Description: Capecitabine 1000 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,   Overall Number of Participants Analyzed: 3   Measure Type: Number   Unit of Measure: Patients experiencing DLT  0