{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"7"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"10"},{"groupId":"OG002","value":"11"},{"groupId":"OG003","value":"10"},{"groupId":"OG004","value":"29"}],"units":"Participants"}],"description":"The primary endpoint was estimated by the number of confirmed responses divided by the total number of evaluable patients per cohort. The study used a two stage Simon design to assess the primary endpoint. A confirmed tumor response rate of 5% was considered not promising; an observed confirmed response rate of 25% was considered promising. One confirmed response within the initial 9 patients enrolled within each cohort, expanded enrollment to 24 patients in that cohort. 3 out of 24 patients with confirmed tumor responses was considered evidence that this treatment could be recommended for further testing. This study design yielded 90% power to detect a true confirmed response rate of at least 25% at .10 level of significance if the true rate is at most 5%. There was a 63% chance of stopping early if the true confirmed response rate was 5%.","groups":[{"description":"Liposarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.","id":"OG000","title":"Cohort 1"},{"description":"Leiomyosarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.","id":"OG001","title":"Cohort 2"},{"description":"Undifferentiated Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.","id":"OG002","title":"Cohort 3"},{"description":"Malignant Peripheral Nerve Sheath Tumor patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.","id":"OG003","title":"Cohort 4"},{"description":"Other Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.","id":"OG004","title":"Cohort 5"}],"paramType":"NUMBER","reportingStatus":"POSTED","timeFrame":"Up to 18 months","title":"The Primary Endpoint for This Trial Was the Percent of Confirmed Tumor Responses. Confirmed Tumor Response to Treatment Was Defined as a Complete or Partial Response(Per RECIST 1.1) on Two Consecutive Evaluations at Least 6 Weeks Apart.","type":"PRIMARY","unitOfMeasure":"percentage of patients with response"}