non small cell lung cancer MedDRA version: 21.1 Level: PT Classification code 10061873 Term: Non-small cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Zykadia 150 mg Hartkapseln
Product Code: LDK378, 150 mg (Studienware)
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: ceritinib
Current Sponsor code: LDK378
Other descriptive name:
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
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. • 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? yes Number of subjects for this age range: 6 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
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. • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To allow continued treatment to patients receiving ceritinib in existing Novartis sponsored studies which have fulfilled the requirements for the primary objective, and in the opinion of the investigator, would benefit from continued treatment.;Secondary Objective: To collect safety data: adverse events (AEs) and serious adverse events (SAEs).;Primary end point(s): Number of patient recieving ceritinib;Timepoint(s) of evaluation of this end point: No stastitical analysis will be performed. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Frequency and nature of adverse events and serious adverse events;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) | — |
Countries
Australia, Belgium, Brazil, Bulgaria, China, Colombia, Czech Republic, France, Germany, Hong Kong, Italy, Japan, Korea, Republic of, Lebanon, Malaysia, New Zealand, Poland, Russian Federation, Singapore, Spain, Sweden, Taiwan, Thailand, United States
Contacts
Public ContactMedizinischer Infoservice (MCC)
Novartis Pharma GmbH
Outcome results
None listed