Roll-over Study to Allow Access to Certinib (LDK378) for Patients Who Are on Ceritinib Treatment in a Novartis-sponsored Study
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ClinicalTrials.gov Identifier: NCT02584933 |
Recruitment Status :
Recruiting
First Posted : October 23, 2015
Last Update Posted : April 22, 2022
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Condition or disease | Intervention/treatment | Phase |
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ALK Positive Malignancies | Drug: ceritinib | Phase 4 |
Expanded Access : An investigational treatment associated with this study is no longer available outside the clinical trial. More info ...
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 252 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Actual Study Start Date : | December 11, 2015 |
Estimated Primary Completion Date : | June 9, 2025 |
Estimated Study Completion Date : | June 9, 2025 |

Arm | Intervention/treatment |
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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.
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Drug: ceritinib
hard gelatin capsule or hard tablet for oral use up to 750 mg |
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Until no patients are left on study up to 5 years ]To collect safety data: adverse events and serious adverse events

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 12 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02584933
Contact: Novartis Pharmaceuticals | 1-888-669-6682 | ||
Contact: Novartis Pharmaceuticals | +41613241111 |

Responsible Party: | Novartis Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT02584933 |
Other Study ID Numbers: |
CLDK378A2X01B |
First Posted: | October 23, 2015 Key Record Dates |
Last Update Posted: | April 22, 2022 |
Last Verified: | April 2022 |
ALK Malignancies |
Neoplasms Ceritinib Antineoplastic Agents |
Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |