Study to allow patients with ALK+ malignancies to continue ceritinib treatment

An open-label, multi-center, Phase IV, roll-over study in patients with ALK positive malignancies who have completed a prior Novartis-sponsored ceritinib (LDK378) study and are judged by the investigator to benefit from continued treatment with ceritinib

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223056

Enrollment

Registered

2015-12-24

Start date

2015-12-11

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ALK+ malignancies

Interventions

investigational material(s) Generic name etc : LDK378 INN of investigational material : ceritinib Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational m

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Patient is currently receiving treatment with ceritinib within a Novartissponsored 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. -Wilingness 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, ideally via an independent trusted witness.

Exclusion criteria

Exclusion criteria: -Patient has been permanently 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. (Patients meeting all other eligibility criteria may be enrolled once toxicities have resolved to allow ceritinib dosing to resume.) -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.

Design outcomes

Primary

Measure	Time frame
safety Frequency and severity of AEs/SAEs	—

Secondary

Measure	Time frame
efficacy Proportion of patients with clinical benefit as assessed by the investigator at scheduled visits.	—

Countries

Asia except Japan, Europe, Japan, North America, Oceania

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026