cMET-dependent malignancies MedDRA version: 21.0 Level: LLT Classification code 10048683 Term: Advanced cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: capmatinib
Product Code: INC280
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: CAPMATINIB
CAS Number: 1197376-85-4
Current Sponsor code: INC280
Other descriptive name: C23H
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Participant is currently receiving capmatinib treatment (within Novartis-sponsored study which is eligible and approved to transition participants to the rollover study) as single agent or in combination or is receiving a combination treatment alone* *This include all participants treated with capmatinib in combination with other treatment that permanently discontinued capmatinib for any reason but are still receiving the combination treatment as single agent. In order to receive the combination treatment as single agent in the rollover study, the treatment needs to be not accessible to the participant outside a clinical trial (e.g. commercially not available or reimbursed). 2.Participant is currently deriving clinical benefit from the study treatment as determined by the Investigator 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 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: 1.Participant is currently not receiving any study treatment due to unresolved toxicities for which study drug dosing has been interrupted or permanently discontinued in the parent protocol (participants meeting all other eligibility criteria may be enrolled once toxicities have resolved to allow study drug dosing to resume) 2.Pregnant or nursing (lactating) women 3.Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception while taking study treatment and for at least 7 days or following combination treatment parent trial recommendation (whichever is longer) of study treatment after stopping medication. 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 (measured as number of SAEs and AEs) ;Secondary Objective: not applicable;Primary end point(s): Frequency and severity of AEs/SAEs;Timepoint(s) of evaluation of this end point: continuous | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable | — |
Countries
Australia, Austria, Belgium, Canada, China, Denmark, France, Germany, Italy, Japan, Korea, Republic of, Singapore, Spain, Sweden, Taiwan, United States
Contacts
Public ContactMedizinischer Infoservice (MCC)
Novartis Pharma GmbH
Outcome results
None listed