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¡¡¡¡2007Äê5ÔÂ27ÈÕһλÊðÃûPbj11µÄÈËÔÚÓë°©Ö¢ÖÎÁÆÓйصÄÍøÕ¾ÉÏ
cancercompassдÏÂÁ˶̶̵仰£º¡°ÎÒ×¢Òâµ½¿µÀ³Ìصģ¨ÃÀ¹ú£©ÁÙ´²Ò»ÆÚʵ
ÑéÒѾÍê³É£¬2003ÄêÅú×¼ÁËÁÙ´²¶þÆÚʵÑ顣Ȼºó£¬¿µÀ³ÌؾʹӵØÇòÉÏÏûʧÁË¡£Ë
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¡¡¡¡Subject: RE: kanglaite
¡¡¡¡Date: 05/27/2007
¡¡¡¡I noticed that Phase I trials for this drug were completed and
Phase II were approved in 2003, but then it seems to fall off the face
of the earth. Does anyone have current inxxxxation about this chinese
herbal drug and it's testing in the U.S. Interesting topic.
¡¡¡¡Pbj11
¡¡¡¡www.cancercompass.com
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¡¡¡¡4£® ¿µÀ´ÌØÔÚÖйúÁÙ´²ÈýÆÚʵÑé¡£
¡¡¡¡1£® Phase I clinical trial in the us and basic studies of KLT in
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¡¡¡¡2£® Phase II clinical study in Russia.
¡¡¡¡3£® Preliminary trial based on US phase II clinical trial protocol.
¡¡¡¡4£® China phase III clinical trials.
¡¡¡¡¶þ£®ÃÀ¹úJohn Hopkins University ´óѧµÄ»ù´¡ÊµÑé
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2¡£ÔÚÄÑÖÎÐÔʵÌåÖ×Áö²¡ÈËÉíÉϼì²â¿µÀ³ÌØ¿¹°©×¢ÉäÒºµÄÒ©´ú¶¯Á¦Ñ§ÄÚÈÝ¡£3¡£¹Û
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¡¡¡¡In June of 2001, the Phase I study of KLT commenced at the
Huntsman Cancer Institute in Salt Lake City, Utah, with the objectives
of 1) To determine the maximum tolerated dose (MTD) and the safety
profile of KLT in patients with refractory solid tumors; 2) To
determine the pharmacokinetics of KLT in patients with refractory
solid tumors; and 3) To gather preliminary efficacy data. The method
of testing is open-label, sequential cohort, dose-escalation study.
¡¡¡¡¾Å£®¿µÀ³ÌØÃÀ¹úÁÙ´²Ò»ÆÚʵÑé½áÊøºóµÄ±¨¸æ
¡¡¡¡Î¬ÀÕÒ½ÉúµÈÔÚ2003Äê×÷µÄÓйؿµÀ³ÌØÁÙ´²Ò»ÆÚʵÑéµÄ±¨¸æ£¨ÕªÒª£©£º£¨Íõ³Î
¸ø¸ÃÒ½Ôº´òÁ˵绰£¬Richard H WheelerάÀÕÒ½ÉúÒѾ²»ÔÚÄǶùÁË¡££©
¡¡¡¡Phase I study of kanglaite (KLT) a botanical product based on
traditional Chinese medicine.
¡¡¡¡Sub-category: Other Novel Agents
¡¡¡¡Category: Developmental Therapeutics - Molecular Therapeutics
¡¡¡¡Meeting: 2003 ASCO Annual Meeting
¡¡¡¡Abstract No: 990 ÕªÒª±àºÅ990
¡¡¡¡Citation: Proc Am Soc Clin Oncol 22: 2003 (abstr 990) ÃÀ¹úÁÙ´²Ö×Áö
ѧ»áÔÓÖ¾2003Äê22¾í
¡¡¡¡Author(s): R. H. Wheeler, L. Busby, W. Samlowski, R. Gerard, H.
Farling; Huntsman Cancer Inst, Salt Lake City, UT; Huntsman Cancer Inst,
Salt Lake City, UT, Albania; Kanglaite USA, Salt Lake City, UT ×÷Õߣº
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¡¡¡¡Abstract: KLT, an acetone extract of the coix seed (Coicis Semen
Yokuinin), is approved in the Peoples Republic of China (PRC) for
treatment of lung and hepatic cancers. The standard dose in the PRC is
20,000 mg/day intravenously (iv) for 20-21 days. We have completed a
phase I trial with pharmacokinetic (PK) analysis of KLT given iv daily
for 21 consecutive days every 4 weeks in adults with refractory solid
tumors. From an initial dose level of 10,000 mg/day, the dose was
increased by 10,000 mg per day in each of four subsequent levels all
infused at a rate of 10,000 mg/hr. Each dose level entered 3 patients
(pts) (4 pts received 30,000 mg/day). 16 pts (12M/4F; median age 67
yrs.(41-80) median PS 70% (60-90) were entered. All are xxxxuable for
toxicity. Primary sites were lung (3 pts), esophagus (3), prostate (2),
mesothelioma (2), colon (2), carcinoid, pancreas, thyroid, and
liposarcoma. KLT has been well tolerated with no Grade 2 or greater
hematologic or symptomatic toxicities. No dose limiting toxicities
were observed in the first cycle up to the maximum dose of 50,000
mg/day. A maximum tolerated dose (MTD) could not be defined. One pt at
the 30,000-mg/day dose level experienced reversable, asymptomatic
grade III elevation of gamma glutamyl transferase and grade II
elevation of alkaline phosphatase during a second cycle. Three pts
stopped treatment after two cycles and one during the first cycle due
to the time commitment required. Of 15 pts xxxxuable for response, 5
had progressive disease, and 10 had stable disease for at least 2
cycles with 4 pts stable for over six months. PK analysis of the
target fatty acids in KLT showed a dose dependent increase in AUC, and
Cmax, with a decrease in T1/2 and Vdss. Full PK studies will be
presented. The dose recommended for further studies is 50,000 mg/day.
¡¡¡¡Ê®£®¿¹°©ÐÂÒ©µÄÃÀ¹úÁÙ´²¶þÆÚʵÑéµÄÄ¿µÄÊÇʲô£¿£¨Ö¸ËùÓеĿ¹°©ÐÂÒ©£©
¡¡¡¡³ýÁËÉÏÃæÃÀ¹ú¹ú¼ÒÎÀÉúÔººÍÃÀ¹ú¹ú¼Ò°©Ö¢ÖÐÐĵÄÖ¸µ¼ÎļþÖÐÖ¸³öµÄ£º¶þÆÚʵ
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¡¡¡¡New trends in assessment in anticancer treatments by phase II
clinical trials
¡¡¡¡[Article in French]
¡¡¡¡Medioni JR, Rycke YD, Asselain B.
¡¡¡¡Unit¨¦ de biostatistique, Institut Curie, 26, rue d'Ulm, 75248
Paris Cedex 05.
¡¡¡¡Ö×ÁöѧµÄÁÙ´²¶þÆÚʵÑéÊÇÆÀ¹ÀеÄÖÎÁÆÓÐûÓÐ×ã¹»£¨Ã÷ÏÔ£©µÄ¿¹Ö×ÁöЧ¹û¡£
ÒÔ´ËÀ´¾ö¶¨ÏÂÒ»²½ÊµÑé¡£ÁÙ´²¶þÆÚʵÑé¶ÔÓÚÒ»¸öеĿ¹°©ÖÎÁƵķ¢Õ¹ÊǹؼüµÄÒ»
²½¡£ËüµÄÄ¿µÄÊǽéÉÜÁƳ̣¬·½·¨£¬¹Û²ìÖÕ¼«Ö¸±ê£¬×î½üµÄ·½·¨ºÍÖ×Áö·´Ó¦ÆÀ¹ÀµÄ
ÐÂÏûÏ¢¡£Í¨³£Ö÷ÒªµÄ¹Û²ìÖÕ¼«Ö¸±êÊÇÖ×Áö±äС¡£ÓÐЩÑо¿ÈËÔ±¹Û²ì´Î¼¶ÖÕ¼«Ö¸±ê£¬
±ÈÈçÏñ´æ»îµÄʱ¼ä»òÖÎÁƵ;ÐÔ¡£
¡¡¡¡The aim of phase II clinical trials in oncology is to judge if a
new treatment have a sufficient antitumor activity to justify further
studies. They represent a crucial step in a new anticancer therapy
development. The aim is to present phase II clinical trials
planification and interpretation methods, end points, recent methods
and news in tumor response assessment. Changes of the place of phase
II clinical trials in a new treatment development strategies are
finally shown. Non randomized trials planification methods (unique
analysis, Gehan's method, Simon's procedure, Fleming's multi-stages
procedure, triangular test) are described. Usual primary end point is
tumor size diminution. Some studies are interested in secondary end
points like survival data or treatment toxicity.
¡¡¡¡£¨¶þ£©1998ÄêµÄһƪÎÄÕ¡£ÌâÄ¿£º¿¹°©ÐÂÒ©µÄÁÙ´²Ò»ÆÚºÍ¶þÆÚʵÑéµÄÆÀ¹À£º
ÖÕ¼«Ö¸±ê£¬ÓÐЧÐÔºÍÕæÊµ´æÔÚÐÔ¡£
¡¡¡¡Ann Oncol. 1998 Oct;9(10):1047-52.
¡¡¡¡Phase I and II trials of novel anti-cancer agents: endpoints,
efficacy and existentialism. The Michel Clavel Lecture, held at the
10th NCI-EORTC Conference on New Drugs in Cancer Therapy, Amsterdam,
16-19 June 1998.
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¡¡¡¡After phase I: Screening for efficacy
¡¡¡¡The goal of phase II trials is to screen agents for their
potential for efficacy. Traditionally this has been measured by
objective tumor regression described using standard criteria (e.g.,
World Health Organization). It is important to point out that response
per se is not synonymous with efficacy; rather, efficacy means
improved cure rates, survival or quality of life. Tumor shrinkage has
proved to be useful as a phase II endpoint because it has allowed us
to select drugs or regimens which have subsequently been shown to be
effective by prolonging survival.
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