E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
cMET-dependent malignancies |
Malignités cMET-dépendantes |
|
E.1.1.1 | Medical condition in easily understood language |
cMET-dependent malignancies |
Malignités cMET-dépendantes |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10061873 |
E.1.2 | Term | Non-small cell lung cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate long term safety data (SAEs and AEs) |
Évaluer les données d’innocuité à long terme (effets indésirables, graves ou non) |
|
E.2.2 | Secondary objectives of the trial |
To evaluate clinical benefit as assessed by the investigator |
Évaluation du bénéfice clinique par le médecin-investigateur |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
1. Recevoir actuellement un traitement par INC280 en monothérapie dans le cadre d’une étude promue par Novartis ayant satisfait aux exigences de l’objectif principal et tirer un bénéfice de la poursuite du traitement par INC280, selon l’avis du médecin-investigateur.
2. Avoir respecté les exigences du protocole de l’étude initiale, selon l’appréciation du médecin-investigateur.
3. Avoir la volonté et la capacité de respecter le calendrier des visites, les modalités du traitement et toute autre procédure de l’étude.
4. Avoir donné son consentement éclairé par écrit avant d’être inclus dans l’étude d’extension et avant l’administration du traitement à l’étude. Si le consentement ne peut pas être donné par écrit, le consentement non écrit devra être formellement documenté en présence d’un témoin, idéalement impartial et digne de confiance. |
|
E.4 | Principal 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 |
1. Patients dont le traitement par INC280 a définitivement été arrêté dans le cadre de l’étude initiale, pour quelque raison que ce soit.
2. Patients présentant actuellement des toxicités non résolues en raison desquelles l’administration d’INC280 a dû être interrompue dans l’étude initiale. (Les patients répondant à tous les autres critères d’éligibilité pourront être inclus une fois les toxicités résolues afin de permettre la reprise du traitement par INC280).
3. Femmes enceintes ou qui allaitent
4. Les femmes en âge d’avoir des enfants, c’est-à-dire toutes les femmes physiologiquement aptes à être enceinte, sauf si elles utilisent une méthode de contraception très efficace pendant toute la durée de l’étude et jusqu’à 7 jours après l’arrêt du traitement.
Se référer au protocole pour les détails et les autres critères d'exclusion |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Frequency and severity of AEs/SAEs |
Fréquence et sévérité des effets indésirables, graves ou non |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
as defined per protocol |
tel que défini par protocole |
|
E.5.2 | Secondary end point(s) |
Proportion of patients with clinical benefit as assessed by the investigator at scheduled visits. |
Proportion de patients pour lesquels un bénéfice clinique est observé par le médecin-investigateur aux visites planifiées. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
as defined per protocol |
tel que défini par protocole |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 24 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Austria |
Belgium |
Czech Republic |
Denmark |
France |
Germany |
Greece |
Italy |
Korea, Republic of |
Netherlands |
Spain |
Sweden |
United Kingdom |
United States |
|
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
The study is expected to remain open for 5 years after the first patient’s first visit in this clinical study or until such time that all enrolled patients no longer need treatment with INC280, whichever comes first. |
L’étude devrait durer 5 ans à compter de la première visite du premier patient ou jusqu’à ce que tous les patients inclus n’aient plus besoin du traitement par INC280, selon ce qui se produit en premier lieu. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 5 |
E.8.9.2 | In all countries concerned by the trial months | 6 |