- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01886287
P:II Above-Label Octreotide-LAR With Insufficiently Controlled Carcinoid Syndrome
Phase II Study of Above-Label Octreotide-LAR in Patients With Insufficiently Controlled Carcinoid Syndrome
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
The study population will consist of patients with advanced (metastatic or unresectable) neuroendocrine tumors with suboptimally controlled carcinoid syndrome. While the majority of patients will have primary tumors of the ileocecum (midgut), any serotonin-producing neuroendocrine tumors will be eligible (including pancreatic, lung and unknown primary).
All patients will be followed for adverse events and serious adverse events for 28 days following the last dose of above-label octreotide, or until resolution or stabilization of the event, whichever comes first.
Type d'étude
Inscription (Réel)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
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Florida
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Tampa, Florida, États-Unis, 33612
- H. Lee Moffitt Cancer Center and Research Institute
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Metastatic neuroendocrine tumors that are considered well or moderately differentiated (or low to intermediate grade). Patients with poorly differentiated neuroendocrine carcinomas or small cell carcinomas are excluded from the study.
- Elevated urine 5-hydroxyindoleacetic acid (5-HIAA)
- More than 2 bowel-movements per day OR more than 4 flushing episodes per week on average
- Patient currently on octreotide LAR 30mg every 3 or 4 weeks (for at least 3 cycles prior to screening)
- Age ≥ 18 years
- Minimum of four weeks since any major surgery, liver-directed therapy (embolization, etc.) or systemic cancer treatment other than octreotide LAR
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2
- Life expectancy > 12 weeks
- Reliable contraception should be maintained throughout the study and for 3 months after study drug discontinuation.
- Signed informed consent to participate in the study must be obtained from patients after they have been fully informed of the nature and potential risks by the investigator (or his/her designee) with the aid of written information.
Exclusion Criteria:
- Known hypersensitivity to somatostatin analogues
- Patients with poorly differentiated neuroendocrine cancers
- Patients with liver cirrhosis
- Patients receiving hemodialysis or peritoneal dialysis
- Patients with cachexia who, in the opinion of the investigator, may have difficulty tolerating intramuscular injection
- Patients with symptomatic cholelithiasis or biliary events within past five years (who have not undergone cholecystectomy)
- Patients with recent history (within 5 years) of pancreatitis
- Patients with uncontrolled diabetes (HgA1c >8.0 despite adequate therapy)
- Women of child-bearing potential, UNLESS they are using two birth control methods
- Women who are pregnant or lactating
- HIV positive patients
- History of sustained ventricular tachycardia, ventricular fibrillation, advanced heart block, idiopathic syncope thought to be related to ventricular arrhythmia, or congenital long QT syndrome
- Risk factors for Torsades de Pointes such as cardiac failure, clinically significant/symptomatic bradycardia
- Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
- History of noncompliance to medical regimens or unwillingness to comply with the protocol
- Patients who were unable to tolerate or did not benefit from above-label dose octreotide (>30mg) in the past
- Concomitant use of other cancer treatments or carcinoid syndrome treatments (whether standard or experimental). Patients should discontinue any concomitant cancer medications more than two weeks prior to screening.
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 |
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Expérimental: Octreotide Long-acting Release (LAR)
Octreotide LAR will be administered at a dose of 60 mg intramuscularly (IM) every 4 weeks.
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Octreotide LAR as outlined in Treatment Arm.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Number of Participants With Improved Frequency of Diarrhea
Délai: At 12 weeks
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The frequencies of flushing, diarrhea, and carcinoid syndrome control rating (scale 1-5) will be measured and compared at week 0 and week 12 .
These measurements will be compared using two-sided non-parametric paired Wilcoxon signed-rank.
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At 12 weeks
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Rate of Progression Free Survival (PFS) at 6 Months
Délai: At 6 months
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Progression-free survival, defined as rate of patients alive and free of progression from the date of first study treatment to the end of trial at 6 months.
Progressive disease (PD): at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.
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At 6 months
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Collaborateurs et enquêteurs
Collaborateurs
Publications et liens utiles
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
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 (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Troubles induits chimiquement
- Tumeurs par type histologique
- Tumeurs
- Adénocarcinome
- Carcinome
- Tumeurs, glandulaires et épithéliales
- Tumeurs neuroectodermiques
- Tumeurs, cellules germinales et embryonnaires
- Tumeurs, tissu nerveux
- Tumeurs neuroendocrines
- Effets secondaires et effets indésirables liés aux médicaments
- Carcinome neuroendocrinien
- Tumeur carcinoïde
- Syndrome carcinoïde malin
- Syndrome sérotoninergique
- Agents antinéoplasiques
- Agents gastro-intestinaux
- Agents antinéoplasiques, hormonaux
- Octréotide
Autres numéros d'identification d'étude
- MCC-17410
- CSMS995AUS64T (Autre identifiant: Novartis)
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 Octreotide LAR
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Federico II UniversityUniversity of Genova; University Hospital, Udine, Italy; University of Perugia...ComplétéTumeurs gastro-intestinales | Tumeurs des voies respiratoires | Tumeurs pancréatiques | Néoplasie endocrinienne multiple | Tumeurs thymiquesItalie
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Azidus BrasilSuspendu
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Novartis PharmaceuticalsComplétéLa maladie de CushingItalie, Belgique, Japon, Allemagne, Royaume-Uni, Thaïlande, Espagne, France, Pays-Bas, Turquie, Israël, Chine, États-Unis, Canada, Inde, Argentine, Brésil, Pérou, Pologne, Fédération Russe
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PfizerComplétéAcromégalieCanada, États-Unis, Allemagne, Italie, Royaume-Uni, Norvège, Australie, Espagne, Brésil, Mexique, France, Pays-Bas
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Columbia UniversityRésiliéTumeur pituitaire | Tumeur pituitaire productrice d'ACTHÉtats-Unis
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Cedars-Sinai Medical CenterNovartis PharmaceuticalsComplété
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Novartis PharmaceuticalsComplétéDiarrhée induite par la chimiothérapieBrésil
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Novartis PharmaceuticalsComplétéTumeur neuroendocrine gastro-entéropancréatique du système pulmonaire ou gastro-entéropancréatiqueAllemagne
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National Academy of Medical Sciences, NepalComplétéDysfonction sexuelle | Chirurgie colorectale | Dysfonctionnement intestinal | Dysfonctionnement de la vessie
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First Affiliated Hospital of Zhejiang UniversityInconnue