Etude : ATALK / ML 39349

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Acronyme / Nom
Situation thérapeutique
Cadre réglementaire
Présentation de l'étude
Acronyme / Nom : ATALK / ML 39349

Situation thérapeutique : Métastatique ou localement avancé

Traitement :

Cadre réglementaire : RIPH1

Dernière MÀJ : 08/11/2019
CIM10 - Localisation(s)
Informations principales
Titre : Etude de phase II, ouverte, multicentrique, mono bras, évaluant l'efficacité et la tolérance d'alectinib chez des patients atteints d'un cancer bronchique non à petites cellules avancé, présentant un réarrangement ALK (Anaplastic Lymphoma Kinase) ayant progressé à la suite d'un traitement par un inhibiteur ALK

Spécialité : Organes respiratoires et intrathoraciques
Localisation : C34 - Tumeur maligne des bronches et du poumon
Informations complémentaires
Schéma : This study will evaluate the efficacy and safety of alectinib, in selected participants, with anaplastic lymphoma kinase-rearranged (ALK-rearranged) non-small cell lung cancer (NSCLC), after disease progression on prior treatment strategy with crizotinib, as only ALK inhibitor, and eventually chemotherapy treatment(s).

1 arm:
- Experimental: Alectinib (600 mg orally twice daily (BID) for up to 2 years)

Phase : II

Stade : NA

2, 3, 4
Critères d'inclusion
Critères de non-inclusion
Critères d'inclusion et de non-inclusion
Critères d'inclusion : - Participants with histologically or cytologically confirmed locally advanced or metastatic NSCLC (Stage IIIB or IV accordingly to American Joint Committee on Cancer [AJCC] classification)
- Life expectancy of at least 12 weeks, in the opinion of the Investigator
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤ 2
- Having contributive biopsy performed on fresh tissue (FFPE blocks required) taken after progression on previous therapy showing presence of anaplastic lymphoma kinase (ALK) rearrangement, assessed by immunohistochemistry (IHC) and confirmed by fluorescence in situ hybridization (FISH)
- Absence of resistance mechanism to alectinib assessed by the Biomarkers Board
- Disease progression, limited to central nervous system (CNS) without possibility of tissue biopsy
- Non-contributive molecular analyses (not enough tumor cells or deoxyribonucleic acid, [DNA] amount or failure of analyses for technical reasons): inclusion is at investigator discretion (decision made upon Biomarker Board recommendation)
- History of crizotinib exposure
- Washout period: if previous progression on crizotinib: 7 days from last intake of the drug
- If previous progression on chemotherapy: 28 days
- If previous radiation therapy: 15 days
- Participants must have recovered from treatment toxicities to ≤ Grade 1 or to their pretreatment levels (for participants who have developed interstitial lung disease [ILD], they must have fully recovered)
- Recovery from effects of any major surgery, or significant traumatic injury, at least 35 days before the first dose of alectinib
- Adequate hematologic function
- Adequate renal function
- For all females of childbearing potential, a negative pregnancy test must be obtained within three days before starting study drug
- For women who are not postmenopausal (≥ 12 months of non-therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use two adequate methods of contraception, including at least one method with a failure rate of < 1% per year, during the treatment period and for at least 90 days after the last dose of study drug
- For men: agreement to remain abstinent or use a barrier method of contraception (e.g., condom) during the treatment period and for at least 90 days after the last dose of study drug and agreement to refrain from donating sperm during this same period
- Participant has national health insurance coverage

Critères de non-inclusion : - Prior therapy with other ALK inhibitors than crizotinib (including alectinib)
- Participants with symptomatic CNS metastases who are neurologically unstable or require increasing doses of steroids within one week prior to Day 0 to manage CNS symptoms
- Participants with progression limited to CNS and eligible to a focal treatment (surgery or stereotaxic radiotherapy)
- Administration of strong/ potent cytochrome P450 3A (CYP3A) inhibitors or inducers, or agents with potential QT prolonging effects within 14 days prior to first administration of study drug
- Liver disease
- Any clinically significant concomitant disease or condition that could interfere with, or for which the treatment might interfere with, the conduct of the study or the absorption of oral medications or that would, in the opinion of the investigator, pose an unacceptable risk to the participant in this study
- Active or uncontrolled infectious diseases requiring treatment
- History of organ transplant
- Participants with baseline QTc > 470 ms or participants with symptomatic bradycardia
- Pregnant or lactating women
- History of hypersensitivity to any of the additives in the alectinib drug
- Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol requirements and/or follow-up procedures; those conditions should be discussed with the participant before trial entry
- Serious, uncontrolled infections or current known infection with human immunodeficiency virus (HIV).
Informations relatives au promoteur
Promoteur :
Type de sponsor : Industriel

Coordonnateur :
Centre investigateur
Informations relatives aux investigateurs
Centre investigateur :
CHU de Rouen - 1 Rue de Germont - 76000 ROUEN

Investigateur :


Statut de l'essai : CLOS

MAJ : 08/11/2019