Ignite Creation Date:
2025-12-25 @ 2:55 AM
Ignite Modification Date:
2026-02-28 @ 10:12 AM
Study NCT ID:
NCT02584933
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-09
First Post:
2015-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Roll-over Study to Allow Access to Certinib (LDK378) for Patients Who Are on Ceritinib Treatment in a Novartis-sponsored Study
Sponsor:
Organization:
Raw JSON
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If consent cannot be expressed in writing, it must be formally documented and witnessed via an independent trusted witness.\n\nExclusion Criteria:\n\n* Patient has been permanently and prematurely discontinued from ceritinib study treatment in the parent study due to any reason.\n* Patient currently has unresolved toxicities for which ceritinib dosing has been interrupted in the parent study.\n* 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.\n* 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.\n* 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.'}, 'identificationModule': {'nctId': 'NCT02584933', 'briefTitle': 'Roll-over Study to Allow Access to Certinib (LDK378) for Patients Who Are on Ceritinib Treatment in a Novartis-sponsored Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'CLDK378A2X01B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ceritinib', 'description': '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.', 'interventionNames': ['Drug: ceritinib']}], 'interventions': [{'name': 'ceritinib', 'type': 'DRUG', 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