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¯E¹©¤w¸g¦b²Ä¤T©u±Ò°Ê833¾¯¶q¥@¥N©µ¦ùÁ{§É¸ÕÅç December 2017 (Final data collection date for primary outcome measure OBI-833/OBI-821 §ïÅܦõ¾¯ >>> OBI-833/OBI-834 ¥ý«e°Êª«¸ÕÅç¬Ý¨ì833+834¡AIgG²£¥Í¸û¦h¡A³o¦¸n¦b¤HÅé¸ÕÅç¬Ý¬Ý¡A¬ü°êFDA¤w©ó¥h¦~¤¹³\¯E¹©±NOBI-833/834Á{§É¤@´ÁIND¨Ö¤JOBI-833 IND¡A¿ï©w¾¯¶q«á±N¶i¤J«áÄòªº¥@¥N©µ¦ù(Expansion Cohort Phase)¸ÕÅç Dose expansion cohorts ¥Øªº¬O¬Æ»ò ? ( «ÂIºK¿ý ×¥¿Â½Ä¶google ) Dose-expansion cohorts (DECs) enable investigators to identify potentially effective drugs, for specific patient populations, in a single trial by assessing antitumour activity as early as possible ¾¯¶q¥@¥N©µ¦ù ¡]DECs¡^Åý¬ã¨s¤Hû¯à°÷¦b³æ¦¸¸ÕÅ礤ºÉ¥i¯à´£¦µû¦ô§Ü¸~½F¬¡©Ê¨Óµû¦ô¯S©w±wªÌ¸sÅ骺¼ç¦b¦³®ÄªºÃĪ« Phase I trial designs increasingly go beyond their former focus on safety, and aim to identify the most-promising agents by adding dose-expansion cohorts (DECs), before moving to phase II testing.2,3 Such phase I trials now frequently include a dose-escalation phase that determines the maximum tolerated dose (MTD), followed by a dose-expansion phase to determine the recommended dose. Patient eligibility criteria for DECs are often narrow and focus on specific molecular characteristics, disease types, or both. DEC trials have various objectives: confirming that a safe level of drug expomentsure has been established; obtaining preliminary evidence of efficacy; and identifying specific patient subgroups that might derive particular benefits from the investigational treat. ¤@´ÁÁ{§É¸ÕÅç³]p¶V¨Ó¶V¶W¶V¥H«e¥u°w¹ï¦w¥þ©ÊªºÃöª`¡A¥Ø¼Ð¦b³q¹L¾¯¶q¥@¥N©µ¦ù¡]DECs¡^¨Ó½T©w³Ì¦³§Æ±æªºÃĪ«¡AµM«á¦A¶i¤JII´Á¸ÕÅç. ¦¹ÃþI´ÁÁ{§É¸ÕÅç²{¦b¸g±`¥]¬A¾¯¶q»¼¼W¶¥¬q½T©w³Ì¤j@¨ü¾¯¶q¡]MTD¡^¡AµM«á¬O¾¯¶qÂX±i¶¥¬q¥H½T©w±ÀÂ˾¯¶q¡CDECsªº±wªÌ¸ê®æ¼Ð·Ç³q±`«ÜÄY®æ¡A±Mª`©ó¯S©wªº¤À¤l¯S¼x¡A¯e¯fÃþ«¬©Î¨âªÌ¡C DEC¸ÕÅ禳¦UºØ¥Ø¼Ð¡G 1½T»{¤w«Ø¥ßªºÃĪ«¦w¥þ¼ÉÅS¼Ð·Ç 2Àò±o¦³®Ä©Êªºªì¨BÃÒ¾Ú 3½T©w±q¬ã¨sªvÀø¤¤Àò±o¯S©w¯q³Bªº¥i¯à¯S©w¦¸±Ú¸s. DECs enable investigators to identify drugs that work best for specific patient populations in the context of a single trial , rather than using separate phase I trials and multiple phase II trials in specific patient populations. The costs and administrative burden associated with conducting separate trials can be greatly reduced, and the resources saved can be allocated to testing other promising compounds. help clinicians decide which drugs to take forward for further testing DECs¨Ï¬ã¨sªÌ¯à°÷¦b³æ¦¸¸ÕÅ窺±¡ªp¤U¹ï¯S©w±wªÌ¸sÅéµû¦ô³Ì¦³®ÄªºÃĪ«¡A¦Ó¤£¬O¨Ï¥Î³æ¿WªºI´Á¸ÕÅç©M¦h¦¸II´Á¸ÕÅç¯S©w±wªÌ¤H¸s¡C¥i¥H¤j¤j´î¤ÖÁ{§É¬ÛÃöªº¶O¥Î©M¦æ¬Ft¾á¡A¸`¬Ùªº¸ê·½¥i¥Î©ó´ú¸Õ¨ä¥L¦³§Æ±æªº¤Æ¦Xª«¡C À°§UÁ{§ÉÂå¥Í¨M©wþ¨ÇÃĪ«»Ý¶i¤@¨B´ú¸Õ www.ncbi.nlm.nih.gov/pmc/articles/PMC4758199/ |
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