Roll-over Study to Allow Access to Certinib (LDK378) for Patients Who Are on Ceritinib Treatment … (NCT02584933) | Clinical Trial Compass
Active — Not RecruitingPhase 4
Roll-over Study to Allow Access to Certinib (LDK378) for Patients Who Are on Ceritinib Treatment in a Novartis-sponsored Study
United States233 participantsStarted 2015-12-11
Plain-language 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.
Who can participate
Age range12 Years – 100 Years
SexALL
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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 dru…
What they're measuring
1
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Timeframe: Until no patients are left on study up to 5 years