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

Not Applicable

Completed

• Conditions: ALK+ malignancies

• Registration Number: JPRN-jRCT2080223056
• Lead Sponsor: ovartis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-12-24
• Study Completion: 2020-05-13
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 5

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

-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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
safety<br>Frequency and severity of AEs/SAEs

Secondary Outcome Measures

Name	Time	Method
efficacy<br>Proportion of patients with clinical benefit as assessed by the<br>investigator at scheduled visits.