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Active (not recruiting) Phase 4 NCT02584933

Roll-over Study to Allow Access to Certinib (LDK378) for Patients Who Are on Ceritinib Treatment in a Novartis-sponsored Study

Phase 4 – monitoring after market approval
Conditions: ALK Positive Malignancies

Sponsor: Novartis Pharmaceuticals

trial.available_in: БГ
Overview
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.
Who can participate
Inclusion Criteria: * 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. Exclusion Criteria: * Patient has been permanently and prematurely discontinued from ceritinib study treatment in the parent study due to any reason. * Patient currently has unresolved toxicities for which ceritinib dosing has been interrupted in the parent study. * Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive serum hCG laboratory test. * Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 3 months afer stopping ceritinib treatment. * Sexually active males unless they use a condom during intercourse while taking drug and for 3 months after stopping ceritinib and should not father a child for at least 3 months after the last dose of treatment.
Locations 21
Australia (1)
Novartis Investigative Site
Melbourne , Victoria
Belgium (1)
Novartis Investigative Site
Leuven
Brazil (1)
Novartis Investigative Site
Natal , Rio Grande do Norte
Bulgaria (1)
Novartis Investigative Site
Sofia
China (1)
Novartis Investigative Site
Guangzhou , Guangdong
Colombia (1)
Novartis Investigative Site
Montería
Czech Republic (1)
Novartis Investigative Site
Brno
France (1)
Novartis Investigative Site
Paris
Germany (1)
Novartis Investigative Site
Regensburg , Bavaria
Hong Kong (1)
Novartis Investigative Site
Hong Kong
Italy (1)
Novartis Investigative Site
Bergamo , BG
Japan (1)
Novartis Investigative Site
Nagoya , Aichi-ken
Lebanon (1)
Novartis Investigative Site
Beirut
Malaysia (1)
Novartis Investigative Site
George Town , Pulau Pinang
Poland (1)
Novartis Investigative Site
Gdansk
Russia (1)
Novartis Investigative Site
Moscow
Singapore (1)
Novartis Investigative Site
Singapore
South Korea (1)
Novartis Investigative Site
Seoul
Spain (1)
Novartis Investigative Site
A Coruña
Taiwan (1)
Novartis Investigative Site
Taichung
United States (1)
Highlands Oncology Group
Fayetteville , Arkansas
Technical details
Status
Active (not recruiting)
Phase
Phase 4
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
12 Years
Maximum age
100 Years
Healthy volunteers
No
Start date
11.12.2015
Completion date
09.06.2027
Registry ID
NCT02584933
Source
anzctr
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