A study for patients who have completed a prior global Novartis sponsored ceritinib (LDK378) study and are judged by the investigator to benefit from continued treatment.
- Conditions
- non small cell lung cancerMedDRA version: 21.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2015-001922-40-BE
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 250
•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.
Other protocol defined inclusion criteria may apply.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 19
• 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.
Other protocol defined exclusion criteria may apply.
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);Secondary Objective: To evaluate clinical benefit as assessed by the investigator.;Primary end point(s): Frequency and severity of AEs/SAEs;Timepoint(s) of evaluation of this end point: The assessment of safety will be based on the frequency of adverse events (AEs) and serious adverse events (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.;Timepoint(s) of evaluation of this end point: At every quarterly visit