{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}],"title":"Change in serum osteopontin after treatment"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}],"title":"Change in serum hyaluronan after treatment"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}],"title":"Change in serum MMP-1 after treatment"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}],"title":"Change in serum MMP-7 after treatment"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}],"title":"Change in serum IL-6 V after treatment"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}],"title":"Change in plasma CCL18 v after treatment"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}],"title":"Change in plasma VEGF after treatment"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}],"title":"Change in plasma PAI-1 after treatment"}],"denoms":[{"counts":[{"groupId":"OG000","value":"13"}],"units":"Participants"}],"description":"Evaluation of changes after treatment therapy to a number of potential blood biomarkers of TGF-β effect (serum osteopontin, serum hyaluronan, serum MMP-1, serum MMP-7, serum IL-6, plasma CCL18, plasma VEGF, and plasma PAI-1). Animal models predict acute changes in TGF-β levels in blood associated with changes in serum biomarkers.","groups":[{"description":"Phase II, Single-Arm, Multi-Site study. All subjects will receive the investigational agent, GC1008 in 3 week cycles of treatment\n\nGC1008: GC1008 is a human IgG4 kappa monoclonal antibody capable of neutralizing all mammalian isoforms of TGFbeta (i.e., beta1, beta 2 and beta 3). GC1008 is a high affinity antibody with dissociation constants (Kds) of 1.8 nM, 2.8 nM and 1.4 nM for TGF1,2,and 3, respectively.","id":"OG000","title":"Investigational Drug infusion-for Safety and Effectiveness"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Outcome analysis presented in manuscript of results of trial based on 13 participants.","reportingStatus":"POSTED","timeFrame":"18 months","title":"Number of Participants With a Change of Serum Biomarkers After Therapy","type":"OTHER_PRE_SPECIFIED","unitOfMeasure":"Participants"}