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

Running, not enrolling · Phase 4

Conditions studied: ALK Positive Malignancies

In brief

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.

Key facts

Study ID

NCT02584933

Run by

Novartis Pharmaceuticals

People needed

233

Starts

2015-12-11

Expected to finish

2027-06-09

Last updated by the study team

2026-06-11

Who can join

Age: 12 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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
• Highlands Oncology Group — Fayetteville, Arkansas, United States

Full record on ClinicalTrials.gov

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