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- Essai clinique NCT05131841
Cipterbin Combined With Vinorelbine in the Treatment of HER2-positive MBC
11 novembre 2021 mis à jour par: wangxiaojia, Zhejiang Cancer Hospital
A Multi-center, Randomized, Open-label Study on Pharmacokinetics, Safety, Efficacy, and Immunogenicity of Cipterbin Combined With Vinorelbine Injection Every Week or Every Three Weeks in the Treatment of Patients With HER2-positive Metastatic Breast Cancer
To compare pharmacokinetics Index of Cipterbin combined with Vinorelbine Injection every week or every three weeks in the treatment of patients with HER2-positive metastatic breast cancer
Aperçu de l'étude
Statut
Recrutement
Les conditions
Intervention / Traitement
Description détaillée
A multi-center, randomized, open-label study on pharmacokinetics, safety, efficacy, and immunogenicity of Cipterbin combined with Vinorelbine Injection every week or every three weeks in the treatment of patients with HER2-positive metastatic breast cancer.
The main purpose was to compare pharmacokinetics Index between two groups, secondly to observe safety, efficacy, and immunogenicity
Type d'étude
Interventionnel
Inscription (Anticipé)
60
Phase
- Phase 4
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Zhejiang
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Hangzhou, Zhejiang, Chine, 310000
- Recrutement
- Zhejiang Cancer Hospital
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Contact:
- Xiaojia Wang
- Numéro de téléphone: +86 13906500190
- E-mail: wxiaojia0803@163.com
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 70 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Femelle
La description
Inclusion Criteria:
- Age ≥18 and ≤70 years old, female.
- BMI index in the range of 19.0~28.0
- ECOG≤1, and the expected os ≥3 months
- Unresectable metastatic breast cancer diagnosed by histology or pathology that has received one or more chemotherapy regimens.
- HER2 overexpression is +++ by immunohistochemistry (IHC) or + by fluorescence hybridization FISH.
- At least one measurable lesion.
- Sufficient organ function
- Voluntarily signed an informed consent form.
- Subjects with good compliance
Exclusion Criteria:
- Rapid disease progression or threaten important organs and require urgent replacement therapy.
- Undergone surgery within 28 days before treatment (except for biopsy)
- Received radiotherapy within 21 days before the first study drug treatment or the side effects of radiotherapy have not recovered to 0 or 1
- Suffer from other serious uncontrolled diseases (such as epilepsy, liver failure, kidney failure, etc.)
- Suffered from other malignant tumors within 5 years before receiving the first study drug treatment or at the same time.
- Severely infected
- Clear history of mental illness, or have a history of alcoholism or drug abuse.
- Central nervous system metastasis or meningeal metastasis with clinical symptoms
- Cardiac function left ventricular ejection fraction < 50%
- Obvious arrhythmia, myocardial ischemia, severe atrioventricular block, cardiac insufficiency, severe heart valve Membrane disease patients
- Poorly controlled hypertension
- Patients with coagulopathy: INR or APTT ≥1.5×ULN
- Allergic to the test drug or its excipients in the study treatment, or have a severe allergic reaction to other monoclonal antibody drugs in the past
- Pregnant or breastfeeding, or cannot take reliable contraceptive measures during the trial and within 6 months after the end of the medication Giver
- Have received a certain test drug in other interventional clinical trials, the interval is less than 28 days or less than 5 half lives of the drug (whichever is longer)
- Have used a monoclonal antibody within 6 months before receiving the first study drug treatment
- Have received other drugs that may affect the pharmacokinetic results of the study drug, the interval is less than 28 days or less than 5 half lives of the drug (whichever is longer)
- Have received organ transplants (including autologous/allologous stem cell transplants) in the past
- Other conditions judged by the investigator to be inappropriate for participating in this trial
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Comparateur actif: One-week group
Cipterbin combined with Vinorelbine Injection every week in the treatment of patients with HER2-positive metastatic breast cancer
|
|
Expérimental: Three-week group
Cipterbin combined with Vinorelbine Injection every three weeks in the treatment of patients with HER2-positive metastatic breast cancer
|
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Cmax
Délai: From enrollment to 21 days after the last dose administrate
|
Cmax after the last administration
|
From enrollment to 21 days after the last dose administrate
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Cmin
Délai: From enrollment to 21 days after the last dose administrate
|
Cmin after the last administration
|
From enrollment to 21 days after the last dose administrate
|
AUC0-t
Délai: From enrollment to 21 days after the last dose administrate
|
AUC0-t after the last administration
|
From enrollment to 21 days after the last dose administrate
|
AUCtau
Délai: From enrollment to 21 days after the last dose administrate
|
AUCtau after the last administration
|
From enrollment to 21 days after the last dose administrate
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Multiple sets of Cmax
Délai: From enrollment to 21 days after the last dose administrate
|
Cmax after the first administration and the third administration in the three-week administration group and the seventh administration in the one-week administration group.
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From enrollment to 21 days after the last dose administrate
|
Multiple sets of Cmin
Délai: From enrollment to 21 days after the last dose administrate
|
Cmin after the first administration and the third administration in the three-week administration group and the seventh administration in the one-week administration group.
|
From enrollment to 21 days after the last dose administrate
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Multiple sets of AUC0-t
Délai: From enrollment to 21 days after the last dose administrate
|
AUC0-t after the first administration and the third administration in the three-week administration group and the seventh administration in the one-week administration group.
|
From enrollment to 21 days after the last dose administrate
|
Multiple sets of AUCtau
Délai: From enrollment to 21 days after the last dose administrate
|
AUCtau after the first administration and the third administration in the three-week administration group and the seventh administration in the one-week administration group.
|
From enrollment to 21 days after the last dose administrate
|
Multiple sets of Tmax
Délai: From enrollment to 21 days after the last dose administrate
|
Tmax after the first administration and the third administration in the three-week administration group and the seventh administration in the one-week administration group.
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From enrollment to 21 days after the last dose administrate
|
Safety index
Délai: From enrollment to 30 days after the last dose administrate
|
Adverse Events during the test
|
From enrollment to 30 days after the last dose administrate
|
BOR
Délai: From enrollment to death(for any reason),Until 24 months after the last subject left the administration group
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Record the proportion of CR and PR in all subjects
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From enrollment to death(for any reason),Until 24 months after the last subject left the administration group
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DCR
Délai: From enrollment to death(for any reason),Until 24 months after the last subject left the administration group
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CR/PR/SD accounted for the proportion of all subjects
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From enrollment to death(for any reason),Until 24 months after the last subject left the administration group
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OS
Délai: From enrollment to death(for any reason),Until 24 months after the last subject left the administration group
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Overall Survival of all subjects
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From enrollment to death(for any reason),Until 24 months after the last subject left the administration group
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Immunogenicity index
Délai: From enrollment to 21 days after the last dose administrate
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ADA
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From enrollment to 21 days after the last dose administrate
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
4 janvier 2021
Achèvement primaire (Anticipé)
30 décembre 2022
Achèvement de l'étude (Anticipé)
30 décembre 2022
Dates d'inscription aux études
Première soumission
3 septembre 2021
Première soumission répondant aux critères de contrôle qualité
11 novembre 2021
Première publication (Réel)
23 novembre 2021
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
23 novembre 2021
Dernière mise à jour soumise répondant aux critères de contrôle qualité
11 novembre 2021
Dernière vérification
1 novembre 2021
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- SSGJ-302H-mBC-IIT-01
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
The data will be shared from the trial begin for 10 years
Délai de partage IPD
From the trial begin for 10 years
Critères d'accès au partage IPD
Every one
Type d'informations de prise en charge du partage d'IPD
- RSE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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