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

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

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

NCT02584933•Novartis Pharmaceuticals

View on ClinicalTrials.gov

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.

Eligibility

Age

12 - 100 years

Sex

ALL

Healthy Volunteers

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.

Locations (71)

Highlands Oncology Group

Fayetteville, Arkansas, United States

Loma Linda University

Loma Linda, California, United States

University of Colorado Cancer Center

Aurora, Colorado, United States

Maryland Oncology Hematology P A

Rockville, Maryland, United States

Essex Oncology of North Jersey PA

Belleville, New Jersey, United States

Novartis Investigative Site

Melbourne, Victoria, Australia

Novartis Investigative Site

Auckland, Australia

Novartis Investigative Site

Leuven, Belgium

Novartis Investigative Site

Natal, Rio Grande do Norte, Brazil

Novartis Investigative Site

Porto Alegre, Rio Grande do Sul, Brazil

Key Dates

Start Date

December 11, 2015

Primary Completion Date

June 9, 2027

Completion Date

June 9, 2027

Last Updated

February 3, 2026

Enrollment

233

ACTUAL participants

Conditions

ALK Positive Malignancies

Interventions

ceritinib

DRUG