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

Study Overview
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Brief Summary
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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
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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

Conditions
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ALK Positive Malignancies

Intervention / Treatment
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* Drug: ceritinib


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ceritinib<br>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. | Drug: ceritinib<br>* hard gelatin capsule or hard tablet for oral use up to 750 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | To collect safety data: adverse events and serious adverse events | Until no patients are left on study up to 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ALK, Malignancies