- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00586105
Phase III Study of Sorafenib in Patients With Renal Cell Carcinoma (RCC)
25 mars 2014 mis à jour par: Bayer
A Multicenter Uncontrolled Study of Sorafenib in Patients With Unresectable and/or Metastatic Renal Cell Carcinoma
A multicenter uncontrolled study of sorafenib in patients with unresectable and/or metastatic renal cell carcinoma (RCC) to assess the pharmacokinetic profile, safety and tolerability, and efficacy.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
39
Phase
- Phase 3
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.
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:
- Patients who have a life expectancy of at least 12 weeks
- Patients, who suffer from unresectable and/or metastatic, measurable RCC histologically or cytologically documented. Patients with rare subtypes of RCC such as pure papillary cell tumor, mixed tumor containing predominantly sarcomatoid cells, Bellini carcinoma, medullary carcinoma, or chromophobe oncocytic tumors are excluded from study participation.
- Patients who have received not more than one prior systemic therapy for advanced disease which was completed at least 30 days prior to the first dose of study medication.
- Patients who have at least one uni-dimensional measurable lesion by Computed Tomography (CT)-scan or Magnetic Resonance Imaging (MRI) according to Response Evaluation Criteria in Solid Tumours (RECIST)
- Patients with "Intermediate" or "low" risk per the Motzer score
- Patients who have an Eastern Co-operative Oncology Group (ECOG) performance status of 0 or 1
- Adequate bone marrow, liver and renal function at screening as assessed by the following:
- Total bilirubin < 1.5 x the upper limit of normal.
- Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) < 2.5 x upper limit of normal (< 5 x upper limit of normal for patients with liver involvement of their cancer).
Amylase and lipase < 1.5 x the upper limit of normal.
- Serum creatinine < 2.0 x the upper limit of normal.
- Prothrombin Time (PT) or International Normalized Ratio (INR) and Partial Thromboplastin Time (PTT) < 1.5 x upper limit of normal
Exclusion Criteria:
- Previous or concurrent cancer that is distinct in primary sit or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, adequately treated basal cell carcinoma, superficial bladder tumors [Ta (Noninvasive papillary carcinoma), Tis (Carcinoma in situ: "flat tumor") and T1 (Tumor invades subepithelial connective tissue)] or any cancer curatively treated > 3 years prior to study entry)
- Patients who completed their prior systemic treatment regimen less than 30 days
- Cardiac arrhythmias requiring anti-arrhythmic (excluding beta blockers or digoxin), symptomatic coronary artery disease or ischemia
- Active clinically serious bacterial or fungal infections
- Known history of human immunodeficiency virus (HIV) infection or chronic hepatitis B or C requiring current interferon treatment
- Symptomatic metastatic brain or meningeal tumors unless the patient is > 6 months from definitive therapy, has a negative imaging studies within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry.
- Patients with evidence or history of bleeding diathesis.
- Patients with seizure disorder requiring medication
- History of organ allograft
- Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
- Pregnant or breast-feeding patients.
Excluded concomitant medications:
- Concurrent anti-cancer chemotherapy, immunotherapy, or hormonal therapy except Bisphosphonates
- Radiotherapy during study or within 3 weeks of start of study drug.
- Biological response modifiers, such as Granulocyte-Colony Stimulating Factor (G-CFS) or Granulocyte macrophage colony-stimulating factor (GM-CFS), within 3 weeks prior to study entry or during study
- Significant surgery within 4 weeks prior to start of study drug
- Autologous bone marrow transplant or stem cell rescue within 4 months of study
- Investigational drug therapy during or within 4 weeks prior to first drug administration and during the study
- St John's Wort
- Xiao Chai Hu Tang
- Prior and concomitant use of Bevacizumab, and all other drugs (investigational or licensed) that target Vascular Endothelial Growth Factor (VEGF)/VEGF-Receptors, Raf-kinase inhibitors (RKI), Methyl Ethyl Ketone (MEK) or Farnesyl transferase inhibitors
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 |
---|---|
Expérimental: Sorafenib (Nexavar, BAY43-9006)
400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)
|
400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Pharmacokinetics Measured as Area Under Curve (AUC[0-12h])
Délai: 12 hours after at least 21 days of uninterrupted dosing
|
The AUC(0-12h) was the observed AUC, calculated using a combination of linear and log trapezoidal rules, from pre-dose to 12 hours post-dose.
The normalized AUC (AUC norm) is AUC (0-12h) divided by (dose [mg]/weight [kg]).
|
12 hours after at least 21 days of uninterrupted dosing
|
Pharmacokinetics Measured as Concentration (Cmax at Tmax and Cmin at Tmin)
Délai: 12 hours after at least 21 days of uninterrupted dosing
|
Cmax (maximum concentration) was measured at the time point at which the maximum concentration (Tmax) was observed.
Cmin (minimum concentration) was measured at the time point at which the minimum concentration (Tmin) was observed.
|
12 hours after at least 21 days of uninterrupted dosing
|
Pharmacokinetics Measured as Concentration (Cmax Normalized at Tmax and Cmin Normalized at Tmin)
Délai: 12 hours after at least 21 days of uninterrupted dosing
|
Cmax (maximum concentration) was measured at the time point at which the maximum concentration (Tmax) was observed.
Cmin (minimum concentration) was measured at the time point at which the minimum concentration (Tmin) was observed.
The normalized variables (Cmax norm and Cmin norm) are the variables (Cmax and Cmin, see Primary Outcome Measure 2) divided by [dose (mg)/weight (kg)].
|
12 hours after at least 21 days of uninterrupted dosing
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Progression Free Survival (PFS)
Délai: Number of days from date of first dose of study drug to date first observed disease progression or death (whichever was earlier) was documented up to 17.25 months
|
Progression-free survival (PFS) was defined as the time from the date of receipt of first dose of study drug to disease progression, radiological or clinical, or death, whichever was earlier.
Subjects still alive without tumor progression at the time of analysis were censored at their date of last tumor evaluation.
|
Number of days from date of first dose of study drug to date first observed disease progression or death (whichever was earlier) was documented up to 17.25 months
|
Overall Survival (OS)
Délai: Time from start of therapy to death up to 17.25 months
|
Overall survival (OS) was measured from the date of first dose of study drug until the date of death due to any cause.
Survival time for subjects still alive at the time of analysis was censored at the date of last contact.
|
Time from start of therapy to death up to 17.25 months
|
Time to Progression (TTP)
Délai: Time from start of study medication to clinical or radiological disease progression which ever occurs first up to 17.25 months
|
Time to progression (TTP) was defined as the time from date of receipt of first dose of study drug to disease progression, radiological or clinical.
Subjects without tumor progression at the time of analysis were censored at their last date of tumor evaluation.
|
Time from start of study medication to clinical or radiological disease progression which ever occurs first up to 17.25 months
|
Disease Control (DC)
Délai: From start to end of study medication up to 17.25 months
|
The DC was defined as subjects who had a best response rating of complete response (CR), partial response (PR), or stable disease (SD) according to Response Evaluation Criteria in Solid Tumors (RECIST) that was maintained for at least 28 days from the first demonstration of that rating.
CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target).
PR: at least a 30% decrease in the sum of longest diameters (LD) of target lesions taking as reference the baseline sum LD.
SD: steady state of disease; do not qualify for PR or progressive disease (PD).
|
From start to end of study medication up to 17.25 months
|
Overall Best Response
Délai: Best response observed from start to end of study medication up to 17.25 months
|
The best overall response was defined as the number of subjects with a confirmed CR, PR, SD, or PD.
Tumor response was evaluated using RECIST.
PD: at least a 20% increase in the sum of LD of measured lesions taking as ref. the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Appearance of new lesions will also constitute PD.
In exceptional circumstances, unequivocal progression of a non-measured lesion may be accepted as evidence of disease progression.
|
Best response observed from start to end of study medication up to 17.25 months
|
Overall Response Duration
Délai: From PR or CR to progression or death up to 17.25 months
|
Overall response duration was to be calculated for subjects who had a confirmed PR or CR, defined as the time from first assessment showing a PR or CR to progression or death.
|
From PR or CR to progression or death up to 17.25 months
|
Time to Objective Response
Délai: Time from start of study medication to first documented PR or CR up to 17.25 months
|
Time to objective response was defined as the time from the date of receipt of first dose of study drug to first assessment showing a confirmed PR or CR.
|
Time from start of study medication to first documented PR or CR up to 17.25 months
|
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 décembre 2005
Achèvement primaire (Réel)
1 mai 2008
Achèvement de l'étude (Réel)
1 mai 2008
Dates d'inscription aux études
Première soumission
21 décembre 2007
Première soumission répondant aux critères de contrôle qualité
3 janvier 2008
Première publication (Estimation)
4 janvier 2008
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
16 avril 2014
Dernière mise à jour soumise répondant aux critères de contrôle qualité
25 mars 2014
Dernière vérification
1 mars 2014
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Tumeurs par type histologique
- Tumeurs
- Tumeurs urologiques
- Tumeurs urogénitales
- Tumeurs par site
- Maladies rénales
- Maladies urologiques
- Adénocarcinome
- Tumeurs, glandulaires et épithéliales
- Tumeurs rénales
- Carcinome à cellules rénales
- Carcinome
- Mécanismes moléculaires de l'action pharmacologique
- Inhibiteurs d'enzymes
- Agents antinéoplasiques
- Inhibiteurs de protéine kinase
- Sorafénib
Autres numéros d'identification d'étude
- 11559 (Identificateur de registre: DAIDS ES Registry Number)
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 .
Essais cliniques sur Carcinome à cellules rénales
-
The Lymphoma Academic Research OrganisationNovartis; Gilead SciencesRecrutementÉligible en hématopathologie ou traitement CAR-t CellFrance
-
Stiftung Swiss Tumor InstituteKlinik Hirslanden, Zurich; Palleos Healthcare GmbHRecrutementMesures des résultats rapportés par les patients | Thérapie CAR T-CellSuisse
-
Dartmouth-Hitchcock Medical CenterComplétéLymphome | Leucémie | Myélome multiple | Greffe de cellules souches | Greffe de cellules souches hématopoïétiques | Thérapie CAR T-Cell | GCSH | Thérapie cellulaire | Transplantation CAR T-CellÉtats-Unis
-
Shenzhen Fifth People's HospitalRecrutement
-
Manchester University NHS Foundation TrustUniversity of Manchester; The Christie NHS Foundation Trust; Zenzium AI Ltd.; Aptus... et autres collaborateursRecrutementCancer colorectal | Cancer du poumon | Cancer hématologique | Thérapie CAR T-CellRoyaume-Uni
-
Sun Yat-sen UniversityPas encore de recrutementCancer du col de l'utérus | Effet de la chimiothérapie | Thérapie néoadjuvante | Programmed Cell Death 1 Receptor / Antagonistes et inhibiteurs
-
University of Alabama at BirminghamRésiliéLymphome anaplasique à grandes cellules | Lymphome T angio-immunoblastique | Lymphomes T périphériques | Leucémie à cellules T de l'adulte | Lymphome T adulte | Lymphome T périphérique Non précisé | T/Null Cell Systemic Type | Lymphome cutané à cellules T avec maladie nodale/viscéraleÉtats-Unis
-
Adelphi Values LLCBlueprint Medicines CorporationComplétéLeucémie mastocytaire (MCL) | Mastocytose systémique agressive (ASM) | SM w Assoc Clonal Hema Non-mast Cell Lineage Disease (SM-AHNMD) | Mastocytose systémique fumante (SSM) | Mastocytose systémique indolente (ISM) Sous-groupe ISM entièrement recrutéÉtats-Unis
-
The First Affiliated Hospital of Xiamen UniversityRecrutementCarcinome réfractaire de la glande thyroïde | Carcinome papillaire de la glande thyroïde réfractaire | Carcinome folliculaire de la glande thyroïde réfractaire | Carcinome réfractaire de la glande thyroïde Hurthle CellChine
-
National Cancer Institute (NCI)ComplétéCarcinome différencié de la glande thyroïde réfractaire | Carcinome de la glande thyroïde non résécable | Carcinome papillaire de la glande thyroïde réfractaire | Carcinome folliculaire de la glande thyroïde réfractaire | Carcinome réfractaire de la glande thyroïde Hurthle CellÉtats-Unis, Canada
Essais cliniques sur Sorafenib (Nexavar, BAY43-9006)
-
BayerComplétéCarcinome hépatocellulaireTaïwan
-
BayerComplétéCarcinome à cellules rénales | Carcinome à cellules rénales (avancé)Pologne, Chine, Slovaquie, France, Allemagne, Indonésie, Corée, République de, Suède, Philippines, L'Autriche, Colombie, République tchèque, Mexique, Fédération Russe, Slovénie, Argentine, Grèce, Pays-Bas
-
BayerComplétéCarcinome à cellules rénalesJapon
-
BayerComplété
-
BayerComplété
-
BayerComplétéCarcinome hépatocellulaireBelgique, France, Espagne, Chine, Hong Kong, États-Unis, Canada, Suisse, Allemagne, Le Portugal, Taïwan, Japon, Fédération Russe, Singapour, L'Autriche, Royaume-Uni, Corée, République de, Australie, Nouvelle-Zélande, Mexique, Brésil et plus
-
BayerRésiliéCarcinome à cellules rénalesItalie, Espagne, France, L'Autriche, Pologne, Royaume-Uni, Irlande
-
BayerComplétéDisponibilité biologiqueAllemagne
-
BayerComplétéCarcinome hépatocellulaireHong Kong, Canada, Fédération Russe, États-Unis, Argentine, Royaume-Uni