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

  • STATUS
    Recruiting
  • End date
    Jan 31, 2023
  • participants needed
    252
  • sponsor
    Novartis Pharmaceuticals
Updated on 15 July 2021
Investigator
Kimberly Walcyzk
Primary Contact
Highlands Oncology Group (1.2 mi away) Contact
+2 other location

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.

Details
Condition ALK Positive Malignancies
Treatment Ceritinib
Clinical Study IdentifierNCT02584933
SponsorNovartis Pharmaceuticals
Last Modified on15 July 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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