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ZGALK002

Alkotinib capsule in patients with alk-positive non-small cell lung cancer previously treated with crizotinib
Source : Importé depuis le centre

Référence clinicaltrials.gov: NCT04211922
Recrutement fermé
Dernière modification : 2024/04/25
Type de recherche

Interventionnel

Médicament expérimental

PHASE2


Population cible

Condition médicale (spécialité visée)

Donnée non disponible

Profil des participants

Sexe(s) des participants

ALL

Source : Importé depuis le centre

Critères de sélection

Critères d'inclusion

Inclusion Criteria:

* Evidence of positive ALK.
* Patients must have demonstrated progression during or after crizotinib treatment.
* Age 18 years or older at the time of informed consent.
* Eastern cooperative oncology group performance status (ECOG PS) of 0-2
* At least one measurable lesion by response evaluation criteria in solid tumors (RECIST) version 1.1 (v1.1).
* Willingness and ability to comply with the trial and follow-up procedures.

Exclusion Criteria:

* chemotherapy, radiation therapy, immunotherapy within 4 weeks.
* Presence of active gastrointestinal (GI) disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of study medications.
* Uncontrolled mass of pleural effusion, pericardial effusion, and peritoneal effusion

Source : Importé depuis le centre

Thérapie ou Intervention proposée

Cohortes
Nom Condition médicale Traitement État du recrutement
Alkotinib 400mg QD 400mg orally once daily. Take Alkotinib at least 1 hour before or at least 2 hours after a meal. Donnée non disponible
  • Inconnu
  • Alkotinib 400mg QD
    État du recrutement
    unknown
    Données à jour depuis : 25 avril 2024

    Description de l'étude

    Résumé de l'étude

    The main purpose of the study is to evaluate safety and efficacy of Alkotinib capsule in patients with ALK-positive non-small cell lung cancer previously treated with crizotinib.While exploring the relationship between biomarkers and drug efficacy and safety.

    Source : Importé depuis le centre

    The drug being tested in this study is called alkotinib. Alkotinib has been demonstrated to benefit people with ALK+ NSCLC.

    The study is a non-control study.

    The study will enroll approximately 104 participants. All participants will take alkotinib 300mg throughout the study.

    This multi-center trial will be conducted in China. The overall time to participate in this study is 3 years. Participants will make multiple visits to the site, and 28 days after last dose of study drug for a follow-up assessment.

    Source : Importé depuis le centre

    Dernière modification : 25 avril 2024
    Données à jour depuis : 2 juin
    Origine des données : clinicaltrials.gov
    Référence clinicaltrials.gov: NCT04211922