- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02447380
Study of AZD6094 (Volitinib) in Combination With Docetaxel, in Advanced Gastric Adenocarcinoma Patients With MET Overexpression as a Second-line Treatment
SAMSUNG MEDICAL CENTER
Phase II, single-arm study of AZD6094 (Volitinib) in combination with docetaxel, in advanced gastric adenocarcinoma patients with MET overexpression as a second-line treatment.
Volitinib is an orally available, potent, selective, small molecule c-MET inhibitor.
Subjects will receive Volitinib once daily (at the MTD determined from Phase Ib) for 21 days as one cycle.
Docetaxel 60 mg/m2 will be administered via intravenous access once every 3 weeks.
To investigate the efficacy of volitinib when given in combination with docetaxel in patients with advanced gastric adenocarcinoma harboring MET overexpression.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Type d'étude
Inscription (Réel)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
-
-
Seoul, Korea, Republic Of
-
Seoul, Seoul, Korea, Republic Of, Corée, République de, 135-710
- Samsung Medical Center
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Provision of fully informed consent prior to any study specific procedures.
- Patients must be ≥20 years of age.
Advanced gastric adenocarcinoma (including GEJ) that has progressed during or after first-line therapy.
- The 1st line regimen must have contained doublet 5-fluoropyrimidine and platinum based regimen.
- Relapse within 6 months of completion of adjuvant/neoadjuvant chemotherapy containing doublet 5-fluoropyrimidine and platinum-based regimen could be considered as 1st line therapy.
- Previous adjuvant/neoadjuvant chemotherapy is allowed, if completed more than 6 months prior to starting the 1st line therapy.
- Provision or availability of biopsy sample for analysis; e.g mandatory pre-treatment biopsy, or available diagnostic biopsy of sufficient quantity/quality
- Patients with MET overexpression
- Patients are willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations.
- ECOG performance status 0-1.
- Patients must have a life expectancy ≥ 3 months from proposed first dose date.
Patients must have acceptable bone marrow, liver and renal function measured within 28 days prior to administration of study treatment as defined below:
- Haemoglobin ≥9.0 g/dL (transfusion allowed)
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
- White blood cells (WBC) > 3 x 109/L
- Platelet count ≥100 x 109/L (transfusion allowed)
- Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (does not include patients with Glibert's disease)
- AST (SGOT)/ALT (SGPT) ≤ 2.5 x institutional upper limit of normal unless liver metastases are present in which case it must be ≤ 5x ULN
- Serum creatinine ≤1.5 x institutional ULN
- At least one measurable lesion that can be accurately assessed by imaging or physical examination at baseline and following up visits.
- Negative urine or serum pregnancy test within 28 days of study treatment, confirmed prior to treatment on day 1. for women of childbearing potential.
- Provision of consent for mandatory biopsy at progression
Exclusion Criteria:
- More than one prior chemotherapy regimen (except for adjuvant/neoadjuvant chemotherapy with more than 6 month wash out period) for the treatment of gastric cancer in the advanced setting.
- Any previous treatment with MET inhibitors
- Any previous treatment with docetaxel.
- Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≤5 years.
- HER2 positive patients (defined by HER2 3+ by immunohistochemistry or HER2 SISH +)
- Patients unable to swallow orally administered medication.
- Treatment with any investigational product during the last 28 days before the enrollment (or a longer period depending on the defined characteristics of the agents used).
- Patients receiving any systemic chemotherapy, radiotherapy (except for palliative reasons), within 3 weeks from the last dose prior to study treatment (or a longer period depending on the defined characteristics of the agents used). The patient can receive a stable dose of bisphosphonates or denosumab for bone metastases, before and during the study as long as these were started at least 4 weeks prior to treatment.
- With the exception of alopecia, any ongoing toxicities (>CTCAE grade 1) caused by previous cancer therapy.
- Intestinal obstruction or CTCAE grade 3 or grade 4 upper GI bleeding within 4 weeks before the enrollment.
- Resting ECG with measurable QTcB > 480 msec on 2 or more time points within a 24 hour period or family history of long QT syndrome.
- Patients with cardiac problem as follows: uncontrolled hypertension (BP ≥150/95 mmHg despite medical therapy) Baseline Left ventricular ejection fraction below the LLN of <55% measured by echocardiography or institution's LLN for MUGA, Atrial fibrillation with a ventricular rate >100 bpm on ECG at rest , Symptomatic heart failure (NYHA grade II-IV), Prior or current cardiomyopathy, Severe valvular heart disease, Uncontrolled angina (Canadian Cardiovascular Society grade II-IV despite medical therapy), Acute coronary syndrome within 6 months prior to starting treatment
- Female patients who are breast-feeding or child-bearing and Male or female patients of reproductive potential who are not employing an effective method of contraception
- Any evidence of severe or uncontrolled systemic disease, active infection, active bleeding diatheses or renal transplant, including any patient known to have hepatitis B, hepatitis C or human immunodeficiency virus (HIV)
- Patients currently receiving (or unable to stop use at least 2 weeks) prior to receiving the first dose of AZD6094, medications known to be potent inhibitors of CYP1A2 or CYP3A4, potent inducers of CYP3A4 or CYP3A4 substrates with a narrow therapeutic range
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: AZD6094 (Volitinib) in combination with docetaxel
Subjects will receive Volitinib once daily (at the MTD determined from Phase Ib) for 21 days as one cycle. Docetaxel 60 mg/m2 will be administered via intravenous access once every 3 weeks. |
AZD6094 600MG qd
Autres noms:
Docetaxel 60 mg/m2
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
Objective response rate (ORR) by RECIST 1.1
Délai: expected average of 24 weeks
|
expected average of 24 weeks
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Durée de la réponse
Délai: moyenne prévue de 24 semaines
|
moyenne prévue de 24 semaines
|
|
Taux de contrôle de la maladie
Délai: 8 semaines
|
8 semaines
|
|
Survie globale (SG)
Délai: moyenne prévue de 24 semaines
|
moyenne prévue de 24 semaines
|
|
survie sans progression (PFS)
Délai: moyenne prévue de 24 semaines
|
moyenne prévue de 24 semaines
|
|
Number of subjects with Adverse Events as a Measure of safety and Tolerability
Délai: expected average of 24 weeks
|
expected average of 24 weeks
|
|
Biomarker analysis
Délai: 3years
|
To see correlation between MetEx14, MET overexpression and to treatment response
|
3years
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2014-07-168
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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 Adénocarcinome gastrique avancé
-
North Dakota State UniversityNational Institutes of Health (NIH)ComplétéRoux en Y Gastric Bypass ChirurgieÉtats-Unis
-
Natalia Valadares de MoraesUniversity of Sao Paulo; Fundação de Amparo à Pesquisa do Estado de São PauloInscription sur invitationImpact de la chirurgie bariatrique sur l'étude pharmacocinétique de la simvastatine et du carvédilolObésité | Chirurgie bariatrique | Roux-en Y Gastric BypassÉtats-Unis
-
Hoffmann-La RocheRésiliéAdvanced BRAFV600 Mélanome de type sauvageÉtats-Unis, Corée, République de, Australie, Belgique, France, Fédération Russe, Italie, Pays-Bas, Espagne, Royaume-Uni, Brésil, Pologne, Allemagne, Grèce, Hongrie
-
Advanced BionicsComplétéPerte auditive sévère à profonde | chez les utilisateurs adultes du système d'oreille bionique Advanced Bionics HiResolution™États-Unis
-
Novartis PharmaceuticalsRecrutementAdvanced EGFRmutant NonSmallSellLungCancer (NSCLC),KRAS G12-mutant NSCLC,Esophageal SquamousCellCancer (SCC),Head/Neck SCC,MélanomePays-Bas, Corée, République de, Espagne, Taïwan, Japon, Italie, Canada, États-Unis, Singapour
-
AstraZenecaRecrutementAdv Solid Malig - H&N SCC, ATM Pro / Def NSCLC, Gastric, Breast and Ovarian CancerEspagne, États-Unis, Belgique, Royaume-Uni, France, Hongrie, Canada, Corée, République de, Australie
Essais cliniques sur AZD6094
-
Samsung Medical CenterComplétéAdénocarcinome gastrique avancéCorée, République de
-
AstraZenecaSCRI Development Innovations, LLCComplétéCancer papillaire des cellules rénalesÉtats-Unis, Canada, Royaume-Uni, Espagne
-
National Cancer Institute (NCI)RésiliéCarcinome colorectal | Adénocarcinome métastatique du côlon | Adénocarcinome rectal métastatique | Cancer du côlon de stade III AJCC v8 | Cancer rectal de stade III AJCC v8 | Cancer du côlon de stade IIIA AJCC v8 | Cancer du rectum de stade IIIA AJCC v8 | Cancer du côlon de stade IIIB AJCC v8 | Cancer... et d'autres conditionsÉtats-Unis
-
AstraZenecaQuotient SciencesComplété
-
Hutchison Medipharma LimitedComplété
-
Jeeyun LeeRecrutementCancer de l'estomac, adénocarcinomeCorée, République de
-
AstraZenecaActif, ne recrute pasCancer du poumon non à petites cellules avancéCanada, Pologne, Taïwan, États-Unis, Corée, République de, Japon, Fédération Russe, Ukraine
-
Queen Mary University of LondonAstraZeneca; Vall d'Hebron Institute of OncologyActif, ne recrute pasCarcinome rénal à cellules claires | Carcinome papillaire rénalRoyaume-Uni
-
Hutchison Medipharma LimitedAstraZenecaComplétéCancer du poumon non à petites cellulesChine
-
Samsung Medical CenterComplétéAdénocarcinome gastrique avancéCorée, République de