A study for patients who have completed a prior global Novartis sponsoredceritinib (LDK378) study and are judged by the investigator to benefit fromcontinued treatment.
- Conditions
- non small cell lung cancerMedDRA version: 21.1Level: PTClassification code: 10061873Term: Non-small cell lung cancer Class: 100000004864Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2024-511040-58-00
- Lead Sponsor
- ovartis Pharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 224
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., 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.
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., Sexually active males unless they use a condom during intercourse while taking drug and after stopping ceritinib and should not father a child in this period.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate long term safety data (SAEs and AEs ). Provide patients access to study drug after parent trials are concluded;Secondary Objective: To evaluate clinical benefit as assessed by the investigator.;Primary end point(s): Frequency and severity of AEs/SAEs
- Secondary Outcome Measures
Name Time Method Secondary end point(s):Proportion of patients with clinical benefit as assessed by the investigator at scheduled visits.