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Asciminib Roll-over Study
Sponsor: Novartis Pharmaceuticals
Summary
This is a long term safety study for patients who have completed a Novartis sponsored asciminib study and are judged by the investigator to benefit from continued treatment
Official title: An Open Label, Multi-center Asciminib Roll-over Study to Assess Long-term Safety in Patients Who Have Completed a Novartis Sponsored Asciminib Study and Are Judged by the Investigator to Benefit From Continued Treatment
Key Details
Gender
All
Age Range
7 Years - 100 Years
Study Type
INTERVENTIONAL
Enrollment
347
Start Date
2022-08-30
Completion Date
2030-08-30
Last Updated
2026-03-06
Healthy Volunteers
No
Interventions
Asciminib single agent
Taken orally, twice daily (BID) or once daily (QD), in fasting state
Imatinib
Taken orally, once daily, in the morning with low-fat meal
Nilotinib
Taken orally, twice daily, on an empty stomach
Bosutinib
Taken orally, once daily, with food
Dasatinib
Taken orally, once daily in a fasted state, 1 or 2 hours before a meal
Asciminib single agent pediatric formulation
Pediatric participants receive a body weight adjusted dose of 1.3 mg/kg of pediatric film coated granules with food twice daily (b.i.d.) or 2.6 mg/kg once daily (q.d.) in the morning.
Locations (84)
Michigan Med University of Michigan
Ann Arbor, Michigan, United States
Memorial Sloan Kettering
New York, New York, United States
Oregon Health Sciences University
Portland, Oregon, United States
Texas Oncology
Dallas, Texas, United States
Uni Of TX MD Anderson Cancer Cntr
Houston, Texas, United States
Novartis Investigative Site
CABA, Buenos Aires, Argentina
Novartis Investigative Site
Capital Federal, Argentina
Novartis Investigative Site
Graz, Austria
Novartis Investigative Site
Vienna, Austria
Novartis Investigative Site
Rio de Janeiro, Rio de Janeiro, Brazil
Novartis Investigative Site
São Paulo, São Paulo, Brazil
Novartis Investigative Site
São Paulo, São Paulo, Brazil
Novartis Investigative Site
Varna, Bulgaria
Novartis Investigative Site
Montreal, Quebec, Canada
Novartis Investigative Site
Chongqing, Chongqing Municipality, China
Novartis Investigative Site
Guangzhou, Guangdong, China
Novartis Investigative Site
Zhengzhou, Henan, China
Novartis Investigative Site
Wuhan, Hubei, China
Novartis Investigative Site
Changchun, Jilin, China
Novartis Investigative Site
Xian, Shanxi, China
Novartis Investigative Site
Chengdu, Sichuan, China
Novartis Investigative Site
Beijing, China
Novartis Investigative Site
Beijing, China
Novartis Investigative Site
Shanghai, China
Novartis Investigative Site
Shenyang, China
Novartis Investigative Site
Tianjin, China
Novartis Investigative Site
Ostrava, Poruba, Czechia
Novartis Investigative Site
Brno, Czechia
Novartis Investigative Site
Copenhagen, Denmark
Novartis Investigative Site
Bordeaux, France
Novartis Investigative Site
Lyon, France
Novartis Investigative Site
Marseille, France
Novartis Investigative Site
Nantes, France
Novartis Investigative Site
Paris, France
Novartis Investigative Site
Vandœuvre-lès-Nancy, France
Novartis Investigative Site
Frankfurt am Main, Hesse, Germany
Novartis Investigative Site
Jena, Thuringia, Germany
Novartis Investigative Site
Berlin, Germany
Novartis Investigative Site
Kiel, Germany
Novartis Investigative Site
Milan, MI, Italy
Novartis Investigative Site
Roma, RM, Italy
Novartis Investigative Site
Naples, Italy
Novartis Investigative Site
Kobe, Japan
Novartis Investigative Site
Beirut, Lebanon
Novartis Investigative Site
George Town, Pulau Pinang, Malaysia
Novartis Investigative Site
Johor Bahru, Malaysia
Novartis Investigative Site
Kuala Selangor, Malaysia
Novartis Investigative Site
Monterrey, Nuevo León, Mexico
Novartis Investigative Site
Khoudh, Oman
Novartis Investigative Site
Katowice, Poland
Novartis Investigative Site
Krakow, Poland
Novartis Investigative Site
Warsaw, Poland
Novartis Investigative Site
Wroclaw, Poland
Novartis Investigative Site
Lisbon, Portugal
Novartis Investigative Site
Porto, Portugal
Novartis Investigative Site
Timișoara, Romania
Novartis Investigative Site
Moscow, Russia
Novartis Investigative Site
Moscow, Russia
Novartis Investigative Site
Saint Petersburg, Russia
Novartis Investigative Site
Saint Petersburg, Russia
Novartis Investigative Site
Riyadh, Saudi Arabia
Novartis Investigative Site
Singapore, Singapore
Novartis Investigative Site
Uijeongbu-si, Gyeonggi-do, South Korea
Novartis Investigative Site
Seoul, Korea, South Korea
Novartis Investigative Site
Busan, South Korea
Novartis Investigative Site
Jeollanam, South Korea
Novartis Investigative Site
Santiago Compostela, A Coruna, Spain
Novartis Investigative Site
Badalona, Barcelona, Spain
Novartis Investigative Site
L'Hospitalet de Llobregat, Barcelona, Spain
Novartis Investigative Site
Bilbao, Bizkaia, Spain
Novartis Investigative Site
Santa Cruz, Santa Cruz De Tenerife, Spain
Novartis Investigative Site
Barcelona, Spain
Novartis Investigative Site
Barcelona, Spain
Novartis Investigative Site
Madrid, Spain
Novartis Investigative Site
Madrid, Spain
Novartis Investigative Site
Madrid, Spain
Novartis Investigative Site
Seville, Spain
Novartis Investigative Site
Valencia, Spain
Novartis Investigative Site
Taoyuan District, Taiwan
Novartis Investigative Site
Samsun, Atakum, Turkey (Türkiye)
Novartis Investigative Site
London, United Kingdom
Novartis Investigative Site
Oxford, United Kingdom
Novartis Investigative Site
Hanoi, Vietnam
Novartis Investigative Site
Ho Chi Minh City, Vietnam