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Roll-over Study to Allow Access to Certinib (LDK378) for Patients Who Are on Ceritinib Treatment in a Novartis-sponsored Study
Sponsor: Novartis Pharmaceuticals
Summary
The rollover study will provide ceritinib to patients who are currently receiving treatment with ceritinib within a Novartis-sponsored study and in the opinion of the investigator, would benefit from continued treatment with ceritinib.
Official title: An Open-label, Multi-center, Phase IV Roll-over Study in Patients With ALK Positive Malignancies Who Have Completed a Novartis-sponsored Ceritinib (LDK378) Study and Are Judged by the Investigator to Benefit From Continued Treatment With Ceritinib
Key Details
Gender
All
Age Range
12 Years - 100 Years
Study Type
INTERVENTIONAL
Enrollment
233
Start Date
2015-12-11
Completion Date
2027-06-09
Last Updated
2026-04-02
Healthy Volunteers
No
Conditions
Interventions
ceritinib
hard gelatin capsule or hard tablet for oral use up to 750 mg
Locations (71)
Highlands Oncology Group
Fayetteville, Arkansas, United States
Loma Linda University
Loma Linda, California, United States
University of Colorado Cancer Center
Aurora, Colorado, United States
Maryland Oncology Hematology P A
Rockville, Maryland, United States
Essex Oncology of North Jersey PA
Belleville, New Jersey, United States
Novartis Investigative Site
Melbourne, Victoria, Australia
Novartis Investigative Site
Auckland, Australia
Novartis Investigative Site
Leuven, Belgium
Novartis Investigative Site
Natal, Rio Grande do Norte, Brazil
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul, Brazil
Novartis Investigative Site
Barretos, São Paulo, Brazil
Novartis Investigative Site
São Paulo, São Paulo, Brazil
Novartis Investigative Site
Sofia, Bulgaria
Novartis Investigative Site
Guangzhou, Guangdong, China
Novartis Investigative Site
Guangzhou, Guangdong, China
Novartis Investigative Site
Changchun, Jilin, China
Novartis Investigative Site
Beijing, China
Novartis Investigative Site
Guangzhou, China
Novartis Investigative Site
Montería, Colombia
Novartis Investigative Site
Brno, Czechia
Novartis Investigative Site
Paris, France
Novartis Investigative Site
Paris, France
Novartis Investigative Site
Saint-Herblain, France
Novartis Investigative Site
Strasbourg, France
Novartis Investigative Site
Villejuif, France
Novartis Investigative Site
Regensburg, Bavaria, Germany
Novartis Investigative Site
Cologne, North Rhine-Westphalia, Germany
Novartis Investigative Site
Essen, Germany
Novartis Investigative Site
Heidelberg, Germany
Novartis Investigative Site
Würzburg, Germany
Novartis Investigative Site
Hong Kong, Hong Kong
Novartis Investigative Site
Bergamo, BG, Italy
Novartis Investigative Site
Bologna, BO, Italy
Novartis Investigative Site
Brescia, BS, Italy
Novartis Investigative Site
Meldola, FC, Italy
Novartis Investigative Site
Monza, MB, Italy
Novartis Investigative Site
Milan, MI, Italy
Novartis Investigative Site
Milan, MI, Italy
Novartis Investigative Site
Rozzano, MI, Italy
Novartis Investigative Site
Modena, MO, Italy
Novartis Investigative Site
Perugia, PG, Italy
Novartis Investigative Site
Aviano, PN, Italy
Novartis Investigative Site
Milan, Italy
Novartis Investigative Site
Naples, Italy
Novartis Investigative Site
Novara, Italy
Novartis Investigative Site
Nagoya, Aichi-ken, Japan
Novartis Investigative Site
Fukuoka, Fukuoka, Japan
Novartis Investigative Site
Akashi, Hyōgo, Japan
Novartis Investigative Site
Koto Ku, Tokyo, Japan
Novartis Investigative Site
Beirut, Lebanon
Novartis Investigative Site
George Town, Pulau Pinang, Malaysia
Novartis Investigative Site
Kuching, Sarawak, Malaysia
Novartis Investigative Site
Gdansk, Poland
Novartis Investigative Site
Moscow, Russia
Novartis Investigative Site
Saint Petersburg, Russia
Novartis Investigative Site
Saint Petersburg, Russia
Novartis Investigative Site
Singapore, Singapore
Novartis Investigative Site
Seoul, South Korea
Novartis Investigative Site
Seoul, South Korea
Novartis Investigative Site
Seoul, South Korea
Novartis Investigative Site
A Coruña, Spain
Novartis Investigative Site
Barcelona, Spain
Novartis Investigative Site
Madrid, Spain
Novartis Investigative Site
Madrid, Spain
Novartis Investigative Site
Málaga, Spain
Novartis Investigative Site
Taichung, Taiwan
Novartis Investigative Site
Taichung, Taiwan
Novartis Investigative Site
Taipei, Taiwan
Novartis Investigative Site
Taipei, Taiwan
Novartis Investigative Site
Taipei, Taiwan
Novartis Investigative Site
Taoyuan District, Taiwan