Statement: In the primary trial, Dasatinib, 70 mg, Twice Daily results in a better median PFS than Dasatinib, 100 mg, Daily. The opposite was true in the secondary trial.
Primary_evidence: Outcome Measurement:    Progression-free Survival   RECIST progression defined as 20% increase in the sum of longest diameters of target measurable lesions over the smallest sum observed, unequivocal progression of non-measurable disease, the appearance of any new lesion/site, death due to disease without prior documentation of progression and without symptomatic deterioration, development of one or more new bone lesions from baseline, or symptomatic deterioration related to disease progression. Time from date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free are censored at last date of contact.   Time frame: Up to 2 years Results 1:    Arm/Group Title: Dasatinib, 100 mg, Daily   Arm/Group Description: Dasatinib, 100 mg PO daily until progression of disease   Overall Number of Participants Analyzed: 41   Median (95% Confidence Interval)   Unit of Measure: weeks  10.3        (8.4 to 16.7) Results 2:    Arm/Group Title: Dasatinib, 70 mg, Twice Daily   Arm/Group Description: Dasatinib, 70 mg PO twice daily until progression of disease   Overall Number of Participants Analyzed: 38   Median (95% Confidence Interval)   Unit of Measure: weeks  15.3        (8.7 to 20.1)
Secondary_evidence: Outcome Measurement:    Number of Patients With Objective Treatment Response (Complete or Partial) in the CNS   Imaging was performed at 8-week intervals to assess response to treatment. Patients with known or suspected leptomeningeal disease were deemed to have a complete response if CSF cytology converted to negative (if positive at baseline) and all meningeal enhancement or nodularity of brain and/or spine MRI resolved. A modified RECIST 1.0 criteria was used to assess CNS response for patients with new or progressing brain metastases. In this modified RECIST criteria, CNS lesions <1cm were not considered measurable, but were considered evaluable for response and progression. Progressive disease for patients with lesions <1 cm was defined as follows: growth of a lesion from less than or equal to 5 mm to greater than or equal to 10mm; or, growth of a 6-9 mm lesion by at least 5 mm in the case of non-target parenchymal brain metastases.   Time frame: Baseline scan prior to study entry was performed within 14 days of cycle 1 day 1, then every 8 weeks from then until disease progression or up to 2 years Results 1:    Arm/Group Title: Irinotecan and Temozolomide   Arm/Group Description: irinotecan hydrochloride administered intravenously (IV) at a starting dose of 125 mg/m2 on days 1 and 15 of a 28 day cycle   temozolomide orally for seven days at a starting dose of 100 mg/m2 on days 1-7 and days 15-21 of a 28 day cycle   Overall Number of Participants Analyzed: 30   Measure Type: Count of Participants   Unit of Measure: Participants  2   6.7%