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

Status: Active_not_recruiting
Location: See all (71) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 100
Healthy Volunteers: f
View:

• Patient is currently receiving treatment with ceritinib within a Novartis-sponsored study which has fulfilled the requirements for the primary objective and, in the opinion of the Investigator, would benefit from continued treatment.

• Patient has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements.

• Willingness and ability to comply with scheduled visits, treatment plans and any other study procedures.

• Written informed consent obtained prior to enrolling in the roll-over study and receiving study medication. If consent cannot be expressed in writing, it must be formally documented and witnessed via an independent trusted witness.

Locations
United States
Arkansas
Highlands Oncology Group
Fayetteville
California
Loma Linda University
Loma Linda
Colorado
University of Colorado Cancer Center
Aurora
Maryland
Maryland Oncology Hematology P A
Rockville
New Jersey
Essex Oncology of North Jersey PA
Belleville
Other Locations
Australia
Novartis Investigative Site
Auckland
Novartis Investigative Site
Melbourne
Belgium
Novartis Investigative Site
Leuven
Brazil
Novartis Investigative Site
Barretos
Novartis Investigative Site
Natal
Novartis Investigative Site
Porto Alegre
Novartis Investigative Site
Sao Paulo
Bulgaria
Novartis Investigative Site
Sofia
China
Novartis Investigative Site
Beijing
Novartis Investigative Site
Changchun
Novartis Investigative Site
Guang Zhou
Novartis Investigative Site
Guangzhou
Novartis Investigative Site
Guangzhou
Colombia
Novartis Investigative Site
Monteria
France
Novartis Investigative Site
Paris
Novartis Investigative Site
Paris
Novartis Investigative Site
Saint Herblain
Novartis Investigative Site
Strasbourg Cedex
Novartis Investigative Site
Villejuif
Germany
Novartis Investigative Site
Essen
Novartis Investigative Site
Heidelberg
Novartis Investigative Site
Koeln
Novartis Investigative Site
Regensburg
Novartis Investigative Site
Wuerzburg
Hong Kong Special Administrative Region
Novartis Investigative Site
Pokfulam
Novartis Investigative Site
Shatin
Italy
Novartis Investigative Site
Aviano
Novartis Investigative Site
Bergamo
Novartis Investigative Site
Bologna
Novartis Investigative Site
Brescia
Novartis Investigative Site
Meldola
Novartis Investigative Site
Milano
Novartis Investigative Site
Milano
Novartis Investigative Site
Milano
Novartis Investigative Site
Modena
Novartis Investigative Site
Monza
Novartis Investigative Site
Napoli
Novartis Investigative Site
Novara
Novartis Investigative Site
Perugia
Novartis Investigative Site
Rozzano
Japan
Novartis Investigative Site
Akashi
Novartis Investigative Site
Fukuoka-city
Novartis Investigative Site
Koto Ku
Novartis Investigative Site
Nagoya
Lebanon
Novartis Investigative Site
Ashrafieh
Malaysia
Novartis Investigative Site
Kuching
Novartis Investigative Site
Pulau Pinang
Poland
Novartis Investigative Site
Gdansk
Republic of Korea
Novartis Investigative Site
Seoul
Novartis Investigative Site
Seoul
Novartis Investigative Site
Seoul
Russian Federation
Novartis Investigative Site
Moscow
Novartis Investigative Site
Saint Petersburg
Novartis Investigative Site
St Petersburg
Singapore
Novartis Investigative Site
Singapore
Spain
Novartis Investigative Site
Barcelona
Novartis Investigative Site
La Coruna
Novartis Investigative Site
Madrid
Novartis Investigative Site
Madrid
Novartis Investigative Site
Malaga
Taiwan
Novartis Investigative Site
Taichung
Novartis Investigative Site
Taichung
Novartis Investigative Site
Taipei
Novartis Investigative Site
Taipei
Novartis Investigative Site
Taipei
Novartis Investigative Site
Taoyuan
Time Frame
Start Date: 2015-12-11
Completion Date: 2027-06-09
Participants
Target number of participants: 233
Treatments
Experimental: ceritinib
The starting dose of study treatment for patients in this protocol should be the same as the dose provided in the parent ceritinib study at the time of the rollover.
Sponsors
Leads: Novartis Pharmaceuticals

This content was sourced from clinicaltrials.gov