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



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:7/5/2018
Start Date:December 11, 2015
End Date:December 14, 2020
Contact:Novartis Pharmaceuticals
Phone:1-888-669-6682

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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

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.


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.
We found this trial at
2
sites
Aurora, Colorado 80045
Principal Investigator: Ross Camidge
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Melbourne, Victoria
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Melbourne,
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