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- Klinische proef NCT00605566
Efficacy Study of Sorafenib and Cyclophosphamide to Treat Neuroendocrine Tumors
Tailored-dose Sorafenib Plus Metronomic Cyclophosphamide in Advanced Neuroendocrine Tumors (NET): a Phase II Clinical Trial Based on Individual Pharmacodynamic Assessment
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 2
Contacten en locaties
Studie Locaties
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Ontario
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Toronto, Ontario, Canada, M5G 2M9
- Princess Margaret Hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Histologically or cytologically confirmed neuroendocrine tumors
- Progressive and measurable metastatic disease
- Patients must not have disease that is currently amenable to surgery
- Life expectancy of greater than 3 months
- ECOG performance status ≤2
- Patients must have normal organ and marrow function
- Negative pregnancy test; agreement to use adequate birth control
Exclusion Criteria:
- Patients receiving chemotherapy or radiotherapy within last 4 weeks
- Patients that had received Sorafenib for advanced NET(neuroendocrine tumors) are not allowed
- Any other investigational agents within 4 weeks of study
- Patients with known brain metastases
- History of allergic reactions to compounds of similar chemical/biologic composition to sorafenib or cyclophosphamide
- Concurrent cancer from another primary site requiring treatment within the past 3 years
- Uncontrolled intercurrent illness
- Pregnant women and women who are breastfeeding
- HIV-positive patients receiving combination anti-retroviral therapy
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: I
Patients will receive sorafenib and cyclophosphamide.
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During a run-in period, patient will start taking 50 mg QD of oral cyclophosphamide and 200 mg BID of sorafenib.
On day 8 of run-in the patient will be evaluated for toxicity.
In the absence of toxicity, the patient will be escalated to sorafenib 400 mg BID and continue on daily 50 mg of cyclophosphamide, or the patient will be informed to continue on sorafenib 200 mg BID and cyclophosphamide 50 mg QD.
Dose escalation procedure will be repeated every 2 weeks until unable to tolerate the study drug, or a maximum of 800 mg BID is reached, or achievement of > 90% inhibition of phosphorylation of PDGFR/Raf axis in PBMC.
After "run-in" period, patient begins cycle 1, each cycle will last 28 days.
Both cyclophosphamide and sorafenib will be taken orally.
Andere namen:
During a run-in period, patient will start taking 50 mg QD of oral cyclophosphamide and 200 mg BID of sorafenib.
On day 8 of run-in the patient will be evaluated for toxicity.
In the absence of toxicity, the patient will be escalated to sorafenib 400 mg BID and continue on daily 50 mg of cyclophosphamide, or the patient will be informed to continue on sorafenib 200 mg BID and cyclophosphamide 50 mg QD.
Dose escalation procedure will be repeated every 2 weeks until unable to tolerate the study drug, or a maximum of 800 mg BID is reached, or achievement of > 90% inhibition of phosphorylation of PDGFR/Raf axis in PBMC.
After "run-in" period, patient begins cycle 1, each cycle will last 28 days.
Both cyclophosphamide and sorafenib will be taken orally.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Efficacy of Combination Sorafenib Plus Metronomic Cyclophosphamide in Advanced, Progressive NET, as Measured by the Objective Response Rate (ORR).
Tijdsspanne: Assessed from start of study treatment until death or disease progression, whichever occurs first up to 7 years
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Objective response (complete and partial) evaluated using RECIST criteria. Complete response (CR): disappearance of all clinical and radiological evidence of tumour (both target and non-target). Partial response (PR): at least a 30% decrease in the sum of longest diameter of target lesions. |
Assessed from start of study treatment until death or disease progression, whichever occurs first up to 7 years
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Association Between p-Shift Changes and Treatment Efficacy of Individual Dose Adjustment of Sorafenib
Tijdsspanne: Assessed from start of study treatment until death, assessed up to 7 years.
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A phosphoshift (pShift) flow cytometry-based test that measures RAF signal transduction capacity in peripheral blood cells was used in order to predict clinical course and/or guide individual dose-titration. Positive pShift values denote stimulation of RAF signal transduction, whereas negative pShift values denote inhibition of RAF signal transduction as measured by flow-cytometry. Associations between pShift changes and treatment efficacy were measured using progression-free survival (PFS) and overall survival (OS). |
Assessed from start of study treatment until death, assessed up to 7 years.
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Progression-free Survival (PFS)
Tijdsspanne: Assessed from start of study treatment until death or disease progression, whichever occurs first up to 7 years
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Progressive disease (PD): at least a 20% increase in the sum of the longest diameter of measured lesions.
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Assessed from start of study treatment until death or disease progression, whichever occurs first up to 7 years
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Overall Survival (OS)
Tijdsspanne: Assessed from start of study treatment until death, assessed up to 7 years.
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Assessed from start of study treatment until death, assessed up to 7 years.
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1-year Survival Rate
Tijdsspanne: 1 year
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Survival rate at 1 year.
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1 year
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Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Neoplasmata per histologisch type
- Neoplasmata
- Neuro-ectodermale tumoren
- Neoplasmata, kiemcellen en embryonaal
- Neoplasmata, zenuwweefsel
- Neuro-endocriene tumoren
- Fysiologische effecten van medicijnen
- Moleculaire mechanismen van farmacologische werking
- Enzymremmers
- Antireumatische middelen
- Antineoplastische middelen
- Immunosuppressieve middelen
- Immunologische factoren
- Antineoplastische middelen, alkylering
- Alkyleringsmiddelen
- Myeloablatieve agonisten
- Proteïnekinaseremmers
- Cyclofosfamide
- Sorafenib
Andere studie-ID-nummers
- SOR-NET-001
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Neuro-endocriene tumoren
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Sorrento Therapeutics, Inc.IngetrokkenVaste tumor | Recidiverende vaste tumor | Refractaire tumor
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Aadi Bioscience, Inc.WervingGeavanceerde vaste tumor | Tumor | Tumor, solideVerenigde Staten
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Memorial Sloan Kettering Cancer CenterWervingVaste tumor | Vaste tumor, volwassen | Vaste tumor, niet gespecificeerd, volwassenVerenigde Staten
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Memorial Sloan Kettering Cancer CenterLincoln Medical and Mental Health CenterWervingVaste tumor | Vaste tumor, volwassen | Vaste tumor, niet gespecificeerd, volwassenVerenigde Staten, Puerto Rico
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Memorial Sloan Kettering Cancer CenterLincoln Medical and Mental Health CenterWervingVaste tumor | Vaste tumor, volwassen | Vaste tumor, niet gespecificeerd, volwassenVerenigde Staten, Puerto Rico
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RemeGen Co., Ltd.VoltooidMetastatische vaste tumor | Lokaal geavanceerde vaste tumor | Inoperabele vaste tumorAustralië
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Baodong QinWervingRefractaire tumor | Zeldzame tumorChina
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National Health Research Institutes, TaiwanNational Cheng-Kung University HospitalWerving
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Elpiscience Biopharma, Ltd.Shanghai Junshi Bioscience Co., Ltd.WervingNeoplasmata | Vaste tumor | Kwaadaardige tumorChina
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The First Affiliated Hospital of Xiamen UniversityWervingVaste tumor | Tumor | Positron-emissietomografieChina
Klinische onderzoeken op Sorafenib
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Ohio State University Comprehensive Cancer CenterBayerBeëindigd
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Technical University of MunichVoltooid
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Ottawa Hospital Research InstituteBayerVoltooidGemetastaseerde colorectale kankerCanada
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BayerAmgenVoltooidCarcinoomVerenigde Staten
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Yiviva Inc.WervingGeavanceerd hepatocellulair carcinoomVerenigde Staten, Taiwan, China, Hongkong
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British Columbia Cancer AgencyIngetrokkenLokaal geavanceerde plaveiselcelcarcinomen van het hoofd en de nek (SCCHN)Canada
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Cancer Institute and Hospital, Chinese Academy...VoltooidHepatocellulair carcinoom, radiotherapie, sorafenibChina
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New Mexico Cancer Care AllianceBeëindigdGemetastaseerd niercelcarcinoomVerenigde Staten
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BayerVoltooidHepatocellulair carcinoomTaiwan
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National Cancer Institute (NCI)VoltooidMultipele endocriene neoplasie type 2A | Multipele endocriene neoplasie type 2B | Terugkerend Schildklier Medullair Carcinoom | Erfelijk Schildklier Medullair Carcinoom | Lokaal gevorderd schildkliermedullair carcinoom | Sporadisch Schildklier Medullair Carcinoom | Stadium III Schildklier Medullair... en andere voorwaardenVerenigde Staten