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- Check4 days agoChange DetectedThe study has expanded to 35 locations and has been updated to revision v2.10.0, replacing the previous revision v2.9.7.SummaryDifference0.3%
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- Check32 days agoChange DetectedThe value 'Show more Show more Revision: v2.9.0' has recently changed to 'Show less Genetic and Rare Diseases Information Center resources: Stomach Cancer FDA Drug and Device Resources Show less Design Details Primary Purpose : Treatment Allocation : N/A Interventional Model : Single Group Assignment Masking : None (Open Label) Arms and Interventions Participant Group/Arm Intervention/Treatment Experimental : ADI-PEG 20 plus modified FOLFOX6 Dose: 36 mg/m2 given weekly Route of Administration: Intramuscular (IM) In combination with modified FOLFOX6, every 2 weeks, intravenous (IV) / IV bolus Drug : ADI-PEG 20 plus modified FOLFOX6 Other Names: pegargiminase Primary Outcome Measures Outcome Measure Measure Description Time Frame Objective response rate (ORR) The percent of subjects who exhibit each level of tumor response, measured by RECIST 1.1 criteria as assessed by blinded independent central review. Date of first study drug administration to the date of disease progression (measured every 8 weeks) or death (whichever occurs first), up to 24 months Secondary Outcome Measures Outcome Measure Measure Description Time Frame Progression free survival (PFS) Time from the first dose until objective tumor progression or death from any cause Date of first study drug administration to the date of disease progression (measured every 8 weeks) or death (whichever occurs first), 12 months anticipated Overall survival (OS) The time from first treatment with ADI-PEG 20 until death or censoring Date of first study drug administration through study completion Duration of response (DoR) the time in weeks between the first occurrence of objective response and the development of progressive disease or death From date of first response until the date of documented progression or date of death, 12 month in average Disease control rate (DCR) the proportion of subjects at each post-baseline assessment who exhibit tumor response of complete response, partial response or stable disease Date of first study drug administration to the date of disease progression (measured every 8 weeks) or death (whichever occurs first), up to 24 months. Pharmacodynamics Blood levels of arginine and citrulline At week 1, 5, 9, 13, 17, 21 prior to ADI-PEG 20 administration Pharmacokinetics Variable Peripheral blood levels of ADI-PEG 20 At week 1, 5, 9, 13, 17, 21 prior to ADI-PEG 20 administration Immunogenicity antibodies to ADI-PEG 20 At week 1, 5, 9, 13, 17, 21 prior to ADI-PEG 20 administration AFP (alpha feto-protein) changes Maximal percent changes of AFP during the course of study compared to AFP at baseline At baseline, week3, 7, 11, 15, 19, 23 and end of treatment Keywords Provided by Polaris Group argininosuccinate synthetase arginine arginine deiminase Additional Relevant MeSH Terms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Adenocarcinoma Liver Neoplasms Liver Diseases Carcinoma Neoplasms Carcinoma, Hepatocellular Studies a U.S. FDA-Regulated Device Product No Revision: v2.9.1'SummaryDifference20%
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