- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01514110
Gastric Cancer RAD001 Study
31. marts 2019 opdateret af: CCTU, Chinese University of Hong Kong
Phase I/II Study of Paclitaxel / Carboplatin / RAD001 as First Line Therapy for Advanced Adenocarcinoma of the Stomach
The purpose of this study is to determine dose limiting toxicities (DLT) and maximum tolerated dose (MTD) of RAD001, as well as to assess tumor response and overall survival.
Studieoversigt
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
35
Fase
- Fase 2
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Hong Kong, Hong Kong
- Department of Clinical Oncology, Prince of Wales Hospital
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Histologically or cytologically proven adenocarcinoma of the stomach. Patients who have adenocarcinoma of the gastroesophageal junction will be eligible if the majority of the tumor bulk is below the junction.
- Metastatic or Loco-regionally advanced disease
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques or as >= 10 mm with spiral CT /MRI scan. See section 11.2 for the evaluation of measurable disease.
- Age >= 18 years.
- Life expectancy of greater than 12 weeks.
- ECOG performance status <= 2 (Karnofsky >= 60%).
Exclusion Criteria:
- Patients who have received more than one line of palliative chemotherapy are allowed, provided that (i) the prior chemotherapy does not contain taxane, cisplatin or carboplatin; (ii) 4 weeks have elapsed prior to the start of the current study treatment, and that (iii) they have recovered from adverse events due to previous treatment [except alopecia].
- Patients who have had radiotherapy or major surgery within 4 weeks prior to entering the study or those who have not recovered from adverse events due to treatment administered more than 4 weeks earlier.
- Patients who are on CYP3A4 modifiers are excluded from the study
- Patients with known brain metastases.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to RAD001.
Significant cardiovascular disease including unstable angina pectoris, uncontrolled hypertension, congestive heart failure related to primary cardiac disease, a condition requiring anti-arrhythmic therapy, ischemic or severe valvular heart disease, or a myocardial infarction within 6 months prior to the trial entry.
- Patients with severe concurrent medical illness such as severe impairment of lung function should be excluded from studies of RAD001.
- Uncontrolled intercurrent such as, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.
- Poorly controlled diabetes mellitus
- High LDL cholesterol or triglyceride level
- Pre-existing neuropathy of >= grade 2
- Patients with a history of second malignancies are eligible they have been disease free for at least 5 years and are deemed by the investigator to be at low risk of recurrence. Par8entswith the following cancers are eligible if diagnosed and treated within the past 5 years: cervical carcinoma in situ, melanoma in situ, and basal cell or squamous cell carcinoma of the skin
- Pregnancy or lactation.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: RAD001
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Pharmacology of RAD001 as a combination partner for conventional agents.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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to determine the Maximum tolerated dose and dose limiting toxicity of RAD001 in combination with paclitaxel and carboplatin
Tidsramme: 2 years
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2 years
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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Toxicity of combination Paclitaxel/carboplatin/RAD001 in advanced adenocarcinoma of the stomach and gastroesophageal junction
Tidsramme: 2 Years
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2 Years
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Winnie Yeo, MD, FRCP, Department of Clinical Oncology, The Chinese University of Hong Kong
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
23. januar 2008
Primær færdiggørelse (Faktiske)
6. marts 2019
Studieafslutning (Faktiske)
6. marts 2019
Datoer for studieregistrering
Først indsendt
22. november 2011
Først indsendt, der opfyldte QC-kriterier
17. januar 2012
Først opslået (Skøn)
20. januar 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
2. april 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
31. marts 2019
Sidst verificeret
1. marts 2019
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Sygdomme i fordøjelsessystemet
- Neoplasmer
- Neoplasmer efter sted
- Gastrointestinale neoplasmer
- Neoplasmer i fordøjelsessystemet
- Gastrointestinale sygdomme
- Mavesygdomme
- Neoplasmer i maven
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Tubulin modulatorer
- Antimitotiske midler
- Mitose modulatorer
- Antineoplastiske midler, fytogene
- Carboplatin
- Paclitaxel
- Everolimus
Andre undersøgelses-id-numre
- GAT006
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Mavekræft
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Medtronic - MITGAfsluttet
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Washington University School of MedicineNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)AfsluttetRoux-en-Y Gastric Bypass | Bariatrisk kirurgi | Vertikal ærmegatrektomi | Mavebånd | Bypass, GastricForenede Stater
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Rijnstate HospitalAfsluttet
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