cMET-dependent malignancies MedDRA version: 19.1 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
Sponsors
Novartis Farmacéutica, S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patient is currently receiving treatment with INC280 monotherapy 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. 2.Patient has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements. 3.Willingness and ability to comply with scheduled visits, treatment plans and any other study procedures. 4.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. 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 48 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 12
Exclusion criteria
Exclusion criteria: 1.Patient has been previously permanently discontinued from INC280 study treatment in the parent study due to any reason. 2.Patient currently has unresolved toxicities for which INC280 dosing has been interrupted in the parent study (Patients meeting all other eligibility criteria may be enrolled once toxicities have resolved to allow INC280 dosing to resume). 3.Pregnant or nursing (lactating) women. 4.Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 7 days after stopping treatment. Please refer to protocol for further details and additional exclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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: as defined per protocol | — |
Secondary
| Measure | Time frame |
|---|---|
| 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: as defined per protocol | — |
Countries
Austria, Belgium, Czech Republic, Denmark, France, Germany, Greece, Italy, Korea, Republic of, Netherlands, Spain, Sweden, United Kingdom, United States
Contacts
Public ContactDepartamento Médico Oncología
Novartis Farmacéutica, S.A.
Outcome results
None listed