Study to allow patients with cMET-dependent malignancies to continue capmatinib treatment
- Conditions
- cMET-dependent malignanciesMedDRA 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)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2016-005144-42-ES
- Lead Sponsor
- ovartis Farmacéutica, S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 60
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
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
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: as defined per protocol
- 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: as defined per protocol