{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"6"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"43"}],"units":"Participants"}],"description":"Progression (PD): 25% increase in the sum of products of all measurable lesions over smallest sum observed, OR clear worsening or failure to return for evalution due to death or deteriorating condition (unless clearly unrelated to brain cancer).\n\nResponses had to be present on 2 consecutive scans and were centrally reviewed.","groups":[{"description":"Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 at MTD phse I. Every 28 days until disease progression or unacceptable toxicity.\n\nGlioblastoma\n\nerlotinib: Given orally\n\ntemsirolimus: Given IV","id":"OG000","title":"Phase II n=43"}],"paramType":"NUMBER","populationDescription":"Primary endpoint PFS6 date of registration; Sample size chosen to discriminate between 15% \\& 35% PFS6 rates for GBM patients. With accrual 32 GBM patients, trial would be considered successful if 8 achieved PFS6. This yields 0.92 power to detect a 35% PFS6 rate, with 0.90 probability of rejecting the treatment regimen if the PFS6 rate is only 15%.","reportingStatus":"POSTED","timeFrame":"Evaluated at baseline and every other cycle, till Month 6","title":"Progression-free Survival at 6 Months (Phase II)","type":"PRIMARY","unitOfMeasure":"participants"}