Informations générales (source: ClinicalTrials.gov)
An Open-label, Multi-center, Phase IV Roll-over Study in Patients With ALK Positive Malignancies Who Have Completed a Novartis-sponsored Ceritinib (LDK378) Study and Are Judged by the Investigator to Benefit From Continued Treatment With Ceritinib
Interventional
Phase 4
Novartis Pharmaceuticals (Voir sur ClinicalTrials)
décembre 2015
juin 2027
14 juin 2025
The rollover study will provide ceritinib to patients who are currently receiving
treatment with ceritinib within a Novartis-sponsored study and in the opinion of the
investigator, would benefit from continued treatment with ceritinib.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | 10/04/2025 13:12:18 | Contact (sur clinicalTrials) | |||
| CLCC INSTITUT GUSTAVE ROUSSY | David PLANCHARD | 17/02/2024 16:46:18 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Novartis Investigative Site - 44805 - Saint Herblain - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 67091 - Strasbourg Cedex - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 75231 - Paris - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 75970 - Paris - France | Contact (sur clinicalTrials) | ||||
| Novartis Investigative Site - 94800 - Villejuif - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- Patient is currently receiving treatment with ceritinib 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.
- Patient has demonstrated compliance, as assessed by the investigator, with the
parent study protocol requirements.
- Willingness and ability to comply with scheduled visits, treatment plans and any
other study procedures.
- 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 via an independent trusted witness.
- Patient is currently receiving treatment with ceritinib 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.
- Patient has demonstrated compliance, as assessed by the investigator, with the
parent study protocol requirements.
- Willingness and ability to comply with scheduled visits, treatment plans and any
other study procedures.
- 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 via an independent trusted witness.
- Patient has been permanently and prematurely discontinued from ceritinib study
treatment in the parent study due to any reason.
- Patient currently has unresolved toxicities for which ceritinib dosing has been
interrupted in the parent study.
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a
female after conception and until the termination of gestation, confirmed by a
positive serum hCG laboratory test.
- 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 3 months afer stopping ceritinib treatment.
- Sexually active males unless they use a condom during intercourse while taking drug
and for 3 months after stopping ceritinib and should not father a child for at least
3 months after the last dose of treatment.