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- Check32 days agoChange DetectedThe value 'Show more Show more Revision: v2.9.0' has been updated to 'Show less MedlinePlus Genetics related topics: Lung cancer Drug Information available for: Sirolimus FDA Drug and Device Resources Show less Design Details Primary Purpose : Treatment Allocation : Non-Randomized Interventional Model : Sequential Assignment Interventional Model Description: For the Dose Escalation cohort: Traditional 3+3 dose escalation design. For the Dose Expansion cohort: Once recommended phase two dose (RP2D) is defined by the PI, a total of 10 NSCLC patients who meet eligibility will be enrolled in the dose expansion cohort. If RP2D is not defined for any reason, the study will be terminated. Masking : None (Open Label) Arms and Interventions Participant Group/Arm Intervention/Treatment Experimental : Sirolimus/Epacadostat Dose Escalation Traditional 3 + 3 dose escalation design. Starting doses: sirolimus 3milligrams (mg) loading/1mg maintenance and epacadostat 300mg twice daily (BID). If 0 in 3 subjects develops dose limiting toxicity (DLT), next 3 subjects will be treated at dose level 2 (DL2): sirolimus 6mg loading/2mg maintenance and epacadostat 300mg BID. If 1 subject in dose level 1 (DL1) develops DLT, 3 additional subjects will be enrolled in DL1. If 2 or more subjects in a total of 6 subjects, or 2 or more subjects in the initial 3 subjects develop DLT, the next 3 subjects will be treated at dose level -1 (DL-1): 3mg loading/1mg sirolimus + epacadostat 100mg BID. If only 1 subject in a total of 6 develops DLT, dose escalation to DL2 will be made for the next 3 subjects. Same algorithm will apply to DL2 except no further dose escalation/de-escalation will be made. Sirolimus lead-in phase: loading dose on day -7 and maintenance dose starting day -6. On Cycle 1 Day 1, epacadostat 300mg BID will be added. Drug : Epacadostat Epacadostat tablet: 100mg or 300mg Other Names: INCB24360 Drug : sirolimus Sirolimus tablet: 1mg, 2mg, 3mg, or 6mg Other Names: rapamycin rapamune Experimental : Sirolimus/Epacadostat Dose Expansion Once recommended phase 2 dose (RP2D) is defined, a total of 10 non-small cell lung cancer (NSCLC) patients who meet eligibility will be enrolled in the dose expansion cohort. Treatment will be sirolimus RP2D once daily and epacadostat RP2D twice daily (BID). Sirolimus lead-in phase: loading dose on day -7 and maintenance dose starting day -6. On Cycle 1 Day 1, epacadostat 300mg BID will be added. Drug : Epacadostat Epacadostat tablet: 100mg or 300mg Other Names: INCB24360 Drug : sirolimus Sirolimus tablet: 1mg, 2mg, 3mg, or 6mg Other Names: rapamycin rapamune Primary Outcome Measures Outcome Measure Measure Description Time Frame Incidence of treatment-emergent adverse events. Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 will be used to measure incidence of treatment-emergent adverse events. 28 days Secondary Outcome Measures Outcome Measure Measure Description Time Frame Overall response response in subjects with NSCLC (dose expansion cohort) Subjects will be assessed every 8 weeks by radiologic imaging to monitor disease status. up to 12 months Disease control rate (DCR) >40% in subjects with NSCLC (dose expansion cohort) Subjects will be assessed at Week 8 by radiologic imaging to monitor disease status. 2 months Median progression free survival (mPFS) >3 months in subjects with NSCLC (dose expansion cohort) Subjects will be assessed every 8 weeks by radiologic imaging to monitor disease status. up to 12 months Median Overall Survival (mOS) > 6 months in subjects with NSCLC (dose expansion cohort) Subjects will be assessed every 8 weeks by radiologic imaging to monitor disease status. up to 12 monthsSummaryDifference25%
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