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International Phase II Trials of AMN-107 (Super-Glivec) & BMS-354825 (Dasatinib) in Korea
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개설일 : 2005/07/31
 

International Phase II Clinical Trials of AMN-107 (Super-Glivec) & BMS-354825 (Dasatinib) in Korea

2005.09.12 08:29 | International Phase II Trials of AMN-107 (Super-Glivec) & BMS-354825 (Dasatinib) in Korea | 김동욱

http://kr.blog.yahoo.com/drdongwkim/157 주소복사

We announce that the AMN-107 and BMS-354825 clinical trials have been started in St. Mary's Hospital, The Catholic University of Korea, Seoul, Korea

The eligible patient group will be the CML (chronic myeloid leukemia) patients who had resistance or intolerance to Imatinib (Glivec)

From March 7, 2005, we have started BMS-354825 clinical trial with 5 protocols as a first clinical trial in whole Asian countries

From September 12, 2005, we started AMN-107 clinical trial and St. Mary's Hospital is only indicated hospital for AMN-107 trial in Asia

We can enroll any imatinib resistant or intolerant Asian CML patients into both clinical trials

If you would like to have more information or to contact us, please call to study coordinator Mrs. Sa-Hee Park (Cellular phone: 82-10-8226-5778/E-mail: saheepark@catholic.ac.kr/dwkim@catholic.ac.kr)

#. Ongoing Clinical Trials with Imatinib (Glivec), Nilotinib (AMN-107), and Dasatinib (BMS-354825) in St. Mary's Hospital, The Catholic University of Korea, Seoul, Korea

1. High dose Imatinib Trial as a Global Phase III Study

-. Study purpose
: to test molecular response between 400mg and 800mg group of imatinib
-. Newly diagnosed CP-CML patients not received interferon or imatinib therapy
-. Age: 18-75 years adult patients
-. provide free study drug (imatinib mesylate; Glivec), blood and bone marrow tests directly related to the study

2. Imatinib dose-escalation Study as a Local Phase III Study

-. Study purpose
: to test additional molecular response after the dose-escalation of imatinib in any responders
-. CML patients who received Imatinib at least one year
-. Age: 18-75 years adult patients
-. provide free study drug (imatinib mesylate; Glivec)

3. Nilotinib (AMN-107; Novartis Co.) Global Phase II Trial for CP, AP, BC-CML resistant or intolerant to Imatinib

-. Imatinib resistant or intolerant CML patients in any phases
-. Age: 18-75 years adult patients
-. provide free study drug, blood and bone marrow tests directly related to study

4. BMS-354825 (Dasatinb, Bristol-Myers-Squibb Co.) Global Phase II Trial: closed in March, 2006

-. Imatinib resistant or intolerant CML patients in any phases
-. Age: 18-75 years adult patients
-. provide free study drug, blood and bone marrow tests directly related to study

International CML Clinical Trial Center in St. Mary's Hospital, Seoul, Korea
-. Outpatient Hematology Clinic in St. Mary's Hospital
-. International CML Clinical Trial Center: 02-3779-1001/02-3779-2001
-. 24hrs Cellular Phone Service: 82-11-707-9119
-. E-mail: saheepark@catholic.ac.kr/dwkim@catholic.ac.kr

Reference homepage
- http://www.klcgb.or.kr (Korean Leukemia Cell and Gene Bank)
- http://www.cmcsungmo.or.kr (St. Mary's Hospital, The Catholic University of Korea)

Reference data published in Korean newspaper
: 한국경제2005.06.02일/한겨레2005.04.26일/조선일보2005.03.22일/연합뉴스2005.03.17일 /YTN2005.2.15일/서울신문2004.12.27일/중앙일보2004.12.23일/한국일보2004.12.23일/국민일보2004.12.23일/YTN2004.12.23일/중앙일보2004.12.06일

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