ÃÀ¹ú¶Å¿Ë´óѧ½ÌÊÚµÄÖÜÄ©
2017-05-10

5ÔÂ5ÈÕ-7ÈÕ £¬±±¾©´óѧµÚÈýÒ½ÔºµÚ¶þ½ìÃÚÄòϵÖ×ÁöרÌâÑÐÌÖ»áÔÚ¾©ÕÙ¿ª¡£ÃÀ¹ú¶Å¿Ë´óѧǰÁÐÏÙÖÐÐÄÖ÷ÈΠJudd W. Moul¡¢ÃÀ¹úÈý̩ҽѧÊý¾ÝÑо¿ËùÊ×ϯ¿ÆÑ§¼ÒËïÁ¢Ó¢½ÌÊÚ¡¢Ì¨Íą̊´óҽѧԺ¸½ÉèÒ½ÔºÖ÷ÈÎÆÑÓÀТ½ÌÊÚ¡¢Öйú¹¤³ÌԺԺʿ/ɽ¶«Ê¡Ö×ÁöÒ½ÔºÔº³¤ÓÚ½ðÃ÷½ÌÊÚ¡¢ÖлªÒ½Ñ§»áÃÚÄòÍâ¿ÆÑ§·Ö»áºòÈÎÖ÷ÈÎίԱ»Æ½¡½ÌÊÚ¡¢°²»ÕÒ½¿Æ´óѧµÚÒ»Á¥ÊôÒ½ÔºÊé¼ÇÁº³¯³¯½ÌÊÚµÈÖî¶àº£ÄÚÍâ¶¥¼âר¼Ò³öϯ £¬È«¹úËİٶàÃûÃÚÄòÍâ¿ÆÒ½Ê¦²Î»á¡£±±¾©´óѧµÚÈýÒ½ÔºÃÚÄòÍâ¿ÆÖ÷ÈÎÂíºÁÖ½ÌÊÚΪ´ó»áÖ÷ϯ¡£

1.jpg

Judd W.MoulÖ¸³ö£ºÏÖ´úǰÁÐÏÙ°©¸ùÖÎÊõÐ뽫ÆäÄÉÈëµ½Ò»¸ö¶àѧ¿Æ¡¢¶àÄ£¿éµÄÕïÁƼƻ®µ±ÖС£ÔÚÄÚÅÅйÖÎÁƺÍRPÓÐЧÐÔÖÐÌá³öÁËÁ½Ïî×î¼ÑµÄÖ§³ÖÊý¾Ý£ºECOG¡ª3886 ÊÔÑé¡¢±È¿¨Â³°·£¨150mg£©EPCÊÔÑé¡£¶øÐÂÓ¢¸ñÀ¼ÔÓÖ¾2017Äê2ÔÂÐû²¼µÄ·ÅÁÆÁªºÏ±È¿¨Â³°·150mg Qd µÄÑ­Ö¤Ñо¿½á¹û±íÃ÷150mg Qd¿ÉÒÔ¸ø»¼Õß´øÀ´¸ü¶àµÄÑ¡Ôñ¡£Óë»áÕß·×·×ÔĶÁ¸ÃÎÄÕ³éÓ¡°æ¡£

ǰÃÀ¹úʳƷҩƷ¹ÜÀí¾Ö£¨FDA£©ÆÀÉó×鳤/ÃÀ¹ú¶Å¿Ë´óѧǰÁÐÏÙÖÐÐÄÊý¾Ý¿âºÍ×éÖ¯¿âÖ÷ÈÎËïÁ¢Ó¢½ÌÊÚ×÷¡°±±ÃÀ°©Ö¢´óÊý¾ÝºÍÓ¦ÓöÔÖйúµÄÆôʾ¡±Ö÷Ìâ³ÂËß¡£

ÌÀƽ¡¢¸µÇ¿µÈ¶Å¿Ë´óѧÍŶÓר¼ÒÕ¹¿ªÁËÈÈÁÒÌÖÂÛ £¬¶ÔÊÀ½ç×îнøÕ¹ £¬ÃÀ¹úǰÁÐÏÙ°©´óÊý¾Ý¶ÔÖйúµÄÆôʾ¡¢T1HGºÍT1G3Ö×ÁöµÄ²¡ÀíÑ§ÌØÕ÷×÷Á˾«²Ê»¥¶¯¡£Öйúҽʦ±¨¶ÔÒÔJudd W.MoulΪÊ׵ĶſËÍŶӽøÐÐÁ˲ɷá£×¨¼ÒÎ§ÈÆÁ÷Ðв¡Ñ§ £¬¹úÄÚÍâ²îÒì £¬¹ú¼Ê×îнøÕ¹ £¬±È¿¨Â³°·ÔÚÖÎÁÆÖеÄְλ½øÐÐÁËÉîÈë¿Í¹ÛµÄÂÛÊö¡£É½Î÷cq9µç×Ó¹ÙÍøÈë¿ÚÖÆÒ©Æ¸ÇëJudd W.Moul, ËïÁ¢Ó¢½ÌÊÚΪcq9µç×Ó¹ÙÍøÈë¿ÚÌØÆ¸×¨¼Ò¡£

4.jpg


5.jpg

½ÓÏÂÀ´ £¬¶Å¿Ë´óѧÍŶÓÒ»ÐÐÀ´µ½cq9µç×Ó¹ÙÍøÈë¿Ú´óÏà £¬ÂÃÐÐÑо¿Ôº £¬²¢¾ÍÃÚÄòÖ×ÁöÑз¢½øÕ¹½øÐÐ×ù̸¡£

2.jpg

´ó»áÉÏ £¬Ì¨ÍåÆÑÓÀТ½ÌÊÚ¶ÔǰÁÐÏÙ°©ÖÎÁÆÖеĹýÓë²»¼°×ö³öÂÛÊö £¬Ö¸³öÄÚÅÅйÖÎÁƶÔÓÚǰÁÐÏÙ°©»¼ÕßÉú´æÖÊÁ¿µÄÖØÒªÐÔ¡£³ÂÖÒÐŽÌÊÚ³ÂËßÁËǰÁÐÏÙ°©Àä¶³ÖÎÁÆ300ÀýµÄÖкã¾ÃËæ·Ã½á¹û¡£½¯ÖǺêÖ÷ÈÎÔò¶ÔÉö°©ÖÎÁÆÖеÄÎÊÌâ½øÐÐÁËÈÈÁÒ̽ÌÖ¡£

Öйúҽʦ±¨¶ÔÒÔÆÑÓÀТΪÊ×µÄר¼ÒÍŶӽøÐÐÁ˲ɷá£×¨¼ÒÎ§ÈÆÌ¨Í嵨ÓòÓë´ó½ÖÎÁÆ´ëÊ©µÄ²îÒì¼°±È¿¨Â³°·µÄÄþ¾²ÐԵȽøÐÐÁ˿͹ÛÂÛÊö¡£É½Î÷cq9µç×Ó¹ÙÍøÈë¿ÚÖÆÒ©Æ¸ÇëÆÑÓÀТ½ÌÊÚΪcq9µç×Ó¹ÙÍøÈë¿ÚÌØÆ¸×¨¼Ò¡£

9.jpg


10.jpg

Ëæºó £¬Ì¨ÍåÍŶÓÒ»ÐÐÂÃÐÐcq9µç×Ó¹ÙÍøÈë¿Ú´óÏò¢×ù̸ £¬Ë«·½½»Á÷Á˱ȿ¨Â³°·º£Íâ×¢²á £¬¶ÔÆÑÓÀТ½ÌÊÚÖ÷³ÖµÄÖ²ÎïÒ©È«Çò¶àÖÐÐÄÁÙ´²ÊÔÑé×öÁËÉîÈë̽ÌÖ¡£

ͨ¹ýÕâ´ÎѧÊõ½»Á÷»î¶¯ £¬ÃÀ¹ú¶Å¿Ë´óѧÍŶӼ°Ì¨Íą̊´óÍŶӶÔÖйúÃñ×åÖÆÒ©ÆóÒµÓÐÁËеÄÈÏʶ £¬ÔÚÌåÏÖÇÕÅåµÄͬʱ £¬Ï£Íûcq9µç×Ó¹ÙÍøÈë¿ÚÖÆÒ©ÄܳÉΪÖйúÖÆÒ©ÆóÒµµÄÓÅÐã´ú±í £¬ÔÚ¹ú¼ÊÎę̀ÉÏ·¢³ö¸ü¶àµÄÉùÒô¡£cq9µç×Ó¹ÙÍøÈë¿ÚÈËÒ²½«½èÖú±¾´Îº£ÄÚÍâѧÕß½»Á÷µÄÆõ»ú £¬×ö´ó¡¢×öǿѧÊõ £¬ÎªÖйúµÄ½¡¿µÊÂÒµíÆíÂǰÐУ¡


ÃÀ¹ú¶Å¿Ë´óѧ½ÌÊÚµÄÖÜÄ©

5ÔÂ5ÈÕ-7ÈÕ £¬±±¾©´óѧµÚÈýÒ½ÔºµÚ¶þ½ìÃÚÄòϵÖ×ÁöרÌâÑÐÌÖ»áÔÚ¾©ÕÙ¿ª¡£ÃÀ¹ú¶Å¿Ë´óѧǰÁÐÏÙÖÐÐÄÖ÷ÈΠJudd W. Moul¡¢ÃÀ¹úÈý̩ҽѧÊý¾ÝÑо¿ËùÊ×ϯ¿ÆÑ§¼ÒËïÁ¢Ó¢½ÌÊÚ¡¢Ì¨Íą̊´óҽѧԺ¸½ÉèÒ½ÔºÖ÷ÈÎÆÑÓÀТ½ÌÊÚ¡¢Öйú¹¤³ÌԺԺʿ/ɽ¶«Ê¡Ö×ÁöÒ½ÔºÔº³¤ÓÚ½ðÃ÷½ÌÊÚ¡¢ÖлªÒ½Ñ§»áÃÚÄòÍâ¿ÆÑ§·Ö»áºòÈÎÖ÷ÈÎίԱ»Æ½¡½ÌÊÚ¡¢°²»ÕÒ½¿Æ´óѧµÚÒ»Á¥ÊôÒ½ÔºÊé¼ÇÁº³¯³¯½ÌÊÚµÈÖî¶àº£ÄÚÍâ¶¥¼âר¼Ò³öϯ £¬È«¹úËİٶàÃûÃÚÄòÍâ¿ÆÒ½Ê¦²Î»á¡£±±¾©´óѧµÚÈýÒ½ÔºÃÚÄòÍâ¿ÆÖ÷ÈÎÂíºÁÖ½ÌÊÚΪ´ó»áÖ÷ϯ¡£

1.jpg

Judd W.MoulÖ¸³ö£ºÏÖ´úǰÁÐÏÙ°©¸ùÖÎÊõÐ뽫ÆäÄÉÈëµ½Ò»¸ö¶àѧ¿Æ¡¢¶àÄ£¿éµÄÕïÁƼƻ®µ±ÖС£ÔÚÄÚÅÅйÖÎÁƺÍRPÓÐЧÐÔÖÐÌá³öÁËÁ½Ïî×î¼ÑµÄÖ§³ÖÊý¾Ý£ºECOG¡ª3886 ÊÔÑé¡¢±È¿¨Â³°·£¨150mg£©EPCÊÔÑé¡£¶øÐÂÓ¢¸ñÀ¼ÔÓÖ¾2017Äê2ÔÂÐû²¼µÄ·ÅÁÆÁªºÏ±È¿¨Â³°·150mg Qd µÄÑ­Ö¤Ñо¿½á¹û±íÃ÷150mg Qd¿ÉÒÔ¸ø»¼Õß´øÀ´¸ü¶àµÄÑ¡Ôñ¡£Óë»áÕß·×·×ÔĶÁ¸ÃÎÄÕ³éÓ¡°æ¡£

ǰÃÀ¹úʳƷҩƷ¹ÜÀí¾Ö£¨FDA£©ÆÀÉó×鳤/ÃÀ¹ú¶Å¿Ë´óѧǰÁÐÏÙÖÐÐÄÊý¾Ý¿âºÍ×éÖ¯¿âÖ÷ÈÎËïÁ¢Ó¢½ÌÊÚ×÷¡°±±ÃÀ°©Ö¢´óÊý¾ÝºÍÓ¦ÓöÔÖйúµÄÆôʾ¡±Ö÷Ìâ³ÂËß¡£

ÌÀƽ¡¢¸µÇ¿µÈ¶Å¿Ë´óѧÍŶÓר¼ÒÕ¹¿ªÁËÈÈÁÒÌÖÂÛ £¬¶ÔÊÀ½ç×îнøÕ¹ £¬ÃÀ¹úǰÁÐÏÙ°©´óÊý¾Ý¶ÔÖйúµÄÆôʾ¡¢T1HGºÍT1G3Ö×ÁöµÄ²¡ÀíÑ§ÌØÕ÷×÷Á˾«²Ê»¥¶¯¡£Öйúҽʦ±¨¶ÔÒÔJudd W.MoulΪÊ׵ĶſËÍŶӽøÐÐÁ˲ɷá£×¨¼ÒÎ§ÈÆÁ÷Ðв¡Ñ§ £¬¹úÄÚÍâ²îÒì £¬¹ú¼Ê×îнøÕ¹ £¬±È¿¨Â³°·ÔÚÖÎÁÆÖеÄְλ½øÐÐÁËÉîÈë¿Í¹ÛµÄÂÛÊö¡£É½Î÷cq9µç×Ó¹ÙÍøÈë¿ÚÖÆÒ©Æ¸ÇëJudd W.Moul, ËïÁ¢Ó¢½ÌÊÚΪcq9µç×Ó¹ÙÍøÈë¿ÚÌØÆ¸×¨¼Ò¡£

4.jpg


5.jpg

½ÓÏÂÀ´ £¬¶Å¿Ë´óѧÍŶÓÒ»ÐÐÀ´µ½cq9µç×Ó¹ÙÍøÈë¿Ú´óÏà £¬ÂÃÐÐÑо¿Ôº £¬²¢¾ÍÃÚÄòÖ×ÁöÑз¢½øÕ¹½øÐÐ×ù̸¡£

2.jpg

´ó»áÉÏ £¬Ì¨ÍåÆÑÓÀТ½ÌÊÚ¶ÔǰÁÐÏÙ°©ÖÎÁÆÖеĹýÓë²»¼°×ö³öÂÛÊö £¬Ö¸³öÄÚÅÅйÖÎÁƶÔÓÚǰÁÐÏÙ°©»¼ÕßÉú´æÖÊÁ¿µÄÖØÒªÐÔ¡£³ÂÖÒÐŽÌÊÚ³ÂËßÁËǰÁÐÏÙ°©Àä¶³ÖÎÁÆ300ÀýµÄÖкã¾ÃËæ·Ã½á¹û¡£½¯ÖǺêÖ÷ÈÎÔò¶ÔÉö°©ÖÎÁÆÖеÄÎÊÌâ½øÐÐÁËÈÈÁÒ̽ÌÖ¡£

Öйúҽʦ±¨¶ÔÒÔÆÑÓÀТΪÊ×µÄר¼ÒÍŶӽøÐÐÁ˲ɷá£×¨¼ÒÎ§ÈÆÌ¨Í嵨ÓòÓë´ó½ÖÎÁÆ´ëÊ©µÄ²îÒì¼°±È¿¨Â³°·µÄÄþ¾²ÐԵȽøÐÐÁ˿͹ÛÂÛÊö¡£É½Î÷cq9µç×Ó¹ÙÍøÈë¿ÚÖÆÒ©Æ¸ÇëÆÑÓÀТ½ÌÊÚΪcq9µç×Ó¹ÙÍøÈë¿ÚÌØÆ¸×¨¼Ò¡£

9.jpg


10.jpg

Ëæºó £¬Ì¨ÍåÍŶÓÒ»ÐÐÂÃÐÐcq9µç×Ó¹ÙÍøÈë¿Ú´óÏò¢×ù̸ £¬Ë«·½½»Á÷Á˱ȿ¨Â³°·º£Íâ×¢²á £¬¶ÔÆÑÓÀТ½ÌÊÚÖ÷³ÖµÄÖ²ÎïÒ©È«Çò¶àÖÐÐÄÁÙ´²ÊÔÑé×öÁËÉîÈë̽ÌÖ¡£

ͨ¹ýÕâ´ÎѧÊõ½»Á÷»î¶¯ £¬ÃÀ¹ú¶Å¿Ë´óѧÍŶӼ°Ì¨Íą̊´óÍŶӶÔÖйúÃñ×åÖÆÒ©ÆóÒµÓÐÁËеÄÈÏʶ £¬ÔÚÌåÏÖÇÕÅåµÄͬʱ £¬Ï£Íûcq9µç×Ó¹ÙÍøÈë¿ÚÖÆÒ©ÄܳÉΪÖйúÖÆÒ©ÆóÒµµÄÓÅÐã´ú±í £¬ÔÚ¹ú¼ÊÎę̀ÉÏ·¢³ö¸ü¶àµÄÉùÒô¡£cq9µç×Ó¹ÙÍøÈë¿ÚÈËÒ²½«½èÖú±¾´Îº£ÄÚÍâѧÕß½»Á÷µÄÆõ»ú £¬×ö´ó¡¢×öǿѧÊõ £¬ÎªÖйúµÄ½¡¿µÊÂÒµíÆíÂǰÐУ¡