E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
different types of advanced cancer |
différents types de cancer avancé |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
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 allow patients enrolled in a LEE011 Novartis-sponsored study continued access to study treatment after the study has reached its primary objective(s) or the study has been terminated for other reasons. |
Permettre aux patients ayant participé à une étude évaluant LEE011 sponsorisée par Novartis de continuer à bénéficier de ce traitement après que l'étude ait atteint son/ses objectif(s) primaire(s) ou soit arrêtée pour d'autres raisons |
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E.2.2 | Secondary objectives of the trial |
To collect safety data for ribociclib as single agent or in combination with other investigational treatments. |
Recueillir les données d'innocuité du ribociclib seul ou associé à d'autres traitements expérimentaux |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Patient is currently enrolled in an eligible Novartis-sponsored ribociclib (LEE011) study and is receiving ribociclib as single agent or in combination with other investigational treatments.
- Patient is currently deriving clinical benefit from the study treatment, as determined by the investigator.
- Patient has demonstrated compliance, as assessed by the investigator, with the parent protocol requirements. |
- Les patients inclus dans une étude éligible sponsorisée par Novartis et qui reçoivent du ribociclib (LEE011) seul ou associé à d'autres traitements expérimentaux
- Les patients qui tirent actuellement un bénéfice du traitement à l'étude, tel que déterminé par le médecin-investigateur.
- Les patients ayant respecté les exigences du protocole parent, selon l'évaluation du médecin-investigateur
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E.4 | Principal exclusion criteria |
- Patients who have permanently discontinued from ribociclib (LEE011) in the parent protocol for any reason.
- Patients who do not meet parent protocol criteria to continue study treatment. |
- Les patients ayant arrêté le ribociclib de façon permanente dans le protocole parent, quelle qu'en soit la raison
- Les patients qui ne remplissent pas les critères pour continuer le traitement à l'étude selon le protocole parent |
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E.5 End points |
E.5.1 | Primary end point(s) |
Number of patients receiving ribociclib as single agent or in combination with other investigational treatments under the rollover study, duration of exposure |
Nombre de patients recevant du LEE011 seul ou associé à d'autres traitements expérimentaux dans le cadre de l'étude d'extension, durée du traitement |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Frequency and nature of adverse events (AEs), serious adverse events (SAE),& liver function tests |
Fréquence et nature des effets indésirables (EI) et des effets indésirables graves (EIG) et tests de la fonction hépatique |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | No |
E.6.4 | Safety | No |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
To allow continued use of ribociclib (LEE011) as single agent or in combination with other investigational treatments in patients benefitting from treatment in an eligible Novartis-sponsored ribociclib (LEE011) study that has reached its primary objective(s) or has been terminated for other reasons. |
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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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
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 | 6 |
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 |
France |
Italy |
Korea, Democratic People's Republic of |
Singapore |
Spain |
Taiwan |
United States |
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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
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The end of the study is defined as the earliest occurrence of one of the following:
- All patients have discontinued the study treatments
- Each of the study treatments supplied in the rollover protocol is commercially available and all ongoing patients are able to obtain access and reimbursement of commercial supply |
La fin de l' étude est définie comme étant la première occurrence de l'une des opérations suivantes:
- Tous les patients ont termines les traitements de l'étude
-Chacun des traitements de l'étude fournis dans le protocole est disponible dans le commerce et tous les patients peuvent obtenir l'accès et le remboursement de l'offre commerciale |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
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 |