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Clinical Trials in the USA / NCT02584933
Active, not recruiting Phase 4

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

NCT02584933 · tracked via the Priya Life Science USA tracker
Sponsor
Novartis Pharmaceuticals
Phase
Phase 4
Started
2015-12-11
Last updated
2026-09-17

Condition(s) studied

ALK Positive Malignancies

Investigational drug(s) / intervention(s)

ceritinib

ceritinib: hard gelatin capsule or hard tablet for oral use up to 750 mg

Study 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

Sex
ALL
Min age
12 Years
Max age
100 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (71)

FacilityCityRegionStatus
Highlands Oncology Group Fayetteville Arkansas
Loma Linda University Loma Linda California
University of Colorado Cancer Center Aurora Colorado
Maryland Oncology Hematology P A Rockville Maryland
Essex Oncology of North Jersey PA Belleville New Jersey
Novartis Investigative Site Melbourne Victoria
Novartis Investigative Site Auckland Australia
Novartis Investigative Site Leuven Belgium
Novartis Investigative Site Natal Rio Grande do Norte
Novartis Investigative Site Porto Alegre Rio Grande do Sul
Novartis Investigative Site Barretos São Paulo
Novartis Investigative Site São Paulo São Paulo
Novartis Investigative Site Sofia Bulgaria
Novartis Investigative Site Guangzhou Guangdong
Novartis Investigative Site Guangzhou Guangdong
Novartis Investigative Site Changchun Jilin
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
Novartis Investigative Site Cologne North Rhine-Westphalia
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
Novartis Investigative Site Bologna BO
Novartis Investigative Site Brescia BS
Novartis Investigative Site Meldola FC
Novartis Investigative Site Monza MB
Novartis Investigative Site Milan MI
Novartis Investigative Site Milan MI
Novartis Investigative Site Milan MI
Novartis Investigative Site Rozzano MI

+ 31 more sites — see the full list on the official registry below.

More Novartis Pharmaceuticals trials in the USA

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02584933 on ClinicalTrials.gov ↗ ← All trials in the USA