- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
Panoramica dello studio
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
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Florida
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Tampa, Florida, Stati Uniti, 33612
- H. Lee Moffitt Cancer Center and Research Institute
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 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.
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Number of Participants With Improved Frequency of Diarrhea
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Rate of Progression Free Survival (PFS) at 6 Months
Lasso di tempo: 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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Collaboratori e investigatori
Collaboratori
Pubblicazioni e link utili
Collegamenti utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Disturbi indotti chimicamente
- Neoplasie per tipo istologico
- Neoplasie
- Adenocarcinoma
- Carcinoma
- Neoplasie, ghiandolari ed epiteliali
- Tumori neuroectodermici
- Neoplasie, cellule germinali ed embrionali
- Neoplasie, tessuto nervoso
- Tumori neuroendocrini
- Effetti collaterali correlati al farmaco e reazioni avverse
- Carcinoma, neuroendocrino
- Tumore carcinoide
- Sindrome da carcinoide maligno
- Sindrome serotoninergica
- Agenti antineoplastici
- Agenti gastrointestinali
- Agenti antineoplastici, ormonali
- Octreotide
Altri numeri di identificazione dello studio
- MCC-17410
- CSMS995AUS64T (Altro identificatore: Novartis)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Octreotide LAR
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Azidus BrasilSospeso
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PfizerCompletatoAcromegaliaCanada, Stati Uniti, Germania, Italia, Regno Unito, Norvegia, Australia, Spagna, Brasile, Messico, Francia, Olanda
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Columbia UniversityTerminatoTumore ipofisario | Tumore ipofisario produttore di ACTHStati Uniti
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Novartis PharmaceuticalsCompletatoTumore neuroendocrino gastroenteropancreatico del sistema polmonare o gastroenteropancreaticoGermania
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Novartis PharmaceuticalsCompletatoDiarrea indotta da chemioterapiaBrasile
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First Affiliated Hospital of Zhejiang UniversitySconosciutoNeoplasie RettaliCina
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Institut du Cancer de Montpellier - Val d'AurelleIntuitive SurgicalAttivo, non reclutante
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Grupo Espanol de Tumores NeuroendocrinosCompletatoNeoplasie gastrointestinaliSpagna