- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00605722
A Study of Tarceva (Erlotinib) and Avastin (Bevacizumab) in Patients With Advanced or Metastatic Liver Cancer.
12 juin 2014 mis à jour par: Hoffmann-La Roche
A Single Arm, Open Label Study of First Line Treatment With Tarceva Plus Avastin on Progression-free Survival in Patients With Advanced or Metastatic Liver Cancer
This single arm study evaluated the efficacy and safety of a combination of Tarceva and Avastin in patients with advanced or metastatic liver cancer.
Patients were treated with Tarceva 150 mg po daily plus Avastin 5 mg/kg intravenous (iv) every 2 weeks.
The anticipated time on study treatment was until disease progression, and the target sample size was <100 individuals.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
51
Phase
- Phase 2
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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Seoul, Corée, République de, 138-736
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Manila, Philippines, 1000
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Kueishan, Taïwan, 333
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Tainan, Taïwan, 704
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Taipei, Taïwan, 00112
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Taipei, Taïwan, 106
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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 et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- adult patients, ≥ 18 years of age;
- advanced or metastatic liver cancer;
- ≥ 1 measurable lesion, not previously treated with local therapy within 4 weeks of enrollment.
Exclusion Criteria:
- prior or concomitant systemic anti-cancer treatment for advanced disease;
- patients at high risk of variceal bleeding;
- clinically significant cardiovascular disease;
- major surgery, open biopsy, or significant traumatic injury within 4 weeks of study start.
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: Non randomisé
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: bevacizumab + erlotinib
Participants received bevacizumab (Avastin) 5 mg/kg intravenous (iv) on day 1 of each 2 week cycle plus erlotinib (Tarceva) 150 mg orally once a day until disease progression or unmanageable toxicity.
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5 mg/kg iv on day 1 of each 2 week cycle.
150 mg orally (po) daily.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Percentage of Participants With Progression-free Survival (PFS)
Délai: Week 16
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Percentage of participants who were alive and without documented progressive disease 16 weeks after their first dose of study drug.
Diagnosis of Progressive Disease was made by objective criteria (RECIST criteria) on the target lesion(s), or by documenting, with Computerised Tomography/Magnetic Resonance Imaging (CT/MRI) scans, the presence of newly occurring lesion(s) arising outside the scanned areas of the target lesions.
PD required at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
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Week 16
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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Overall Response Rate (ORR)
Délai: Event driven (median follow-up 12 months)
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ORR was defined as the percentage of participants with Complete Response (CR) or Partial Response (PR).
Analysis of tumor response was based on the best overall response according to Response Evaluation Criteria in Solid Tumors (RECIST), which was defined as the best response recorded from the start of trial treatment until disease progression/recurrence (or death), taking as reference for progressive disease (PD) the smallest measurements recorded since the treatment started.
CR was defined as the disappearance of all target lesions; for non-target lesions disappearance of lesions and normal tumour marker levels.
PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, using as reference the Baseline sum LD.
PD required at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
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Event driven (median follow-up 12 months)
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Disease Control Rate (DCR)
Délai: Event driven (median follow-up 12 months)
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Disease Control Rate was defined as the percentage of participants with Complete Response (CR), Partial Response (PR) or Stable Disease (SD) for at least 8 weeks by Response Evaluation Criteria in Solid Tumours (RECIST).
CR was defined as the disappearance of all target lesions; for non-target lesions disappearance of lesions and normal tumour marker levels.
PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, using as reference the Baseline sum LD.
SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started; for non-target lesions persistence of one or more non-target lesion(s) and/or maintenance of tumour marker level above the normal limits.
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Event driven (median follow-up 12 months)
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Time to Tumor Progression
Délai: Event driven (median follow-up 12 months)
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Time to tumor progression was defined as the time period in months from the start of study drug treatment to disease progression.
Progressive disease required at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
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Event driven (median follow-up 12 months)
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Progression-free Survival (PFS)
Délai: Event driven (median follow-up 12 months)
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PFS was defined as the time period in months from the start of study drug treatment to the first of either progression or death.
Progressive disease required at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
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Event driven (median follow-up 12 months)
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Overall Survival (OS)
Délai: Event driven (median follow-up 12 months)
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OS was defined as the time period in months from the start of study drug treatment to death.
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Event driven (median follow-up 12 months)
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Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Délai: Up to 107 Weeks
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An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug.
Preexisting conditions that worsened during the study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug were reported as adverse events.
A SAE was any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.
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Up to 107 Weeks
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
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
1 mars 2008
Achèvement primaire (Réel)
1 septembre 2010
Achèvement de l'étude (Réel)
1 septembre 2010
Dates d'inscription aux études
Première soumission
18 janvier 2008
Première soumission répondant aux critères de contrôle qualité
18 janvier 2008
Première publication (Estimation)
31 janvier 2008
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
14 juillet 2014
Dernière mise à jour soumise répondant aux critères de contrôle qualité
12 juin 2014
Dernière vérification
1 juin 2014
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies du système digestif
- Tumeurs
- Tumeurs par site
- Tumeurs du système digestif
- Maladies du foie
- Tumeurs du foie
- Effets physiologiques des médicaments
- Mécanismes moléculaires de l'action pharmacologique
- Inhibiteurs d'enzymes
- Agents antinéoplasiques
- Agents antinéoplasiques immunologiques
- Inhibiteurs de l'angiogenèse
- Agents modulateurs de l'angiogenèse
- Substances de croissance
- Inhibiteurs de croissance
- Inhibiteurs de protéine kinase
- Chlorhydrate d'erlotinib
- Bévacizumab
Autres numéros d'identification d'étude
- ML21213
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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