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Safety and Efficacy of RAD001 (Everolimus) Monotherapy Plus Best Supportive Care in Patients With Advanced Gastric Cancer (AGC) (GRANITE-1)

8 października 2015 zaktualizowane przez: Novartis Pharmaceuticals

A Randomized, Double-blind, Multi-center Phase III Study Comparing Everolimus (RAD001) Plus Best Supportive Care Versus Placebo Plus Best Supportive Care in Patients With Advanced Gastric Cancer After Progression on 1 or 2 Prior Systemic Chemotherapy

This study is designed to assess the safety and efficacy of RAD001 monotherapy in patients with advanced gastric cancer which has progressed after one or two lines of prior chemotherapy.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

656

Faza

  • Faza 3

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Argentyna
      • Buenos Aires, Argentyna, C1264AAA
        • Novartis Investigative Site
      • Cordoba, Argentyna, X5000IUG
        • Novartis Investigative Site
    • Viedma
      • Rio Negro, Viedma, Argentyna, 8500
        • Novartis Investigative Site
  • Australia
    • Australian Capital Territory
      • Canberra, Australian Capital Territory, Australia, 2605
        • Novartis Investigative Site
    • Queensland
      • Herston, Queensland, Australia, 4029
        • Novartis Investigative Site
    • South Australia
      • Kurralta Park, South Australia, Australia, 5037
        • Novartis Investigative Site
      • North Adelaide, South Australia, Australia, 5006
        • Novartis Investigative Site
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Novartis Investigative Site
      • Clayton, Victoria, Australia, 3168
        • Novartis Investigative Site
      • Footscray, Victoria, Australia, 3011
        • Novartis Investigative Site
      • Heidelberg, Victoria, Australia, 3084
        • Novartis Investigative Site
      • Prahran, Victoria, Australia, 3181
        • Novartis Investigative Site
  • Belgia
      • Charleroi, Belgia, 6000
        • Novartis Investigative Site
      • Gent, Belgia, 9000
        • Novartis Investigative Site
      • Leuven, Belgia, 3000
        • Novartis Investigative Site
      • Liege, Belgia, 4000
        • Novartis Investigative Site
  • Chiny
      • Beijing, Chiny, 100039
        • Novartis Investigative Site
      • Beijing, Chiny, 100036
        • Novartis Investigative Site
      • Guangzhou, Chiny, 510060
        • Novartis Investigative Site
      • Shanghai, Chiny, 200032
        • Novartis Investigative Site
      • Shanghai, Chiny, 200003
        • Novartis Investigative Site
      • Shanghai, Chiny, 200025
        • Novartis Investigative Site
    • Guangdong
      • Guangzhou, Guangdong, Chiny, 510515
        • Novartis Investigative Site
    • Hebei
      • Shijiazhuang, Hebei, Chiny, 050011
        • Novartis Investigative Site
    • Heilongjiang
      • Harbin, Heilongjiang, Chiny, 150081
        • Novartis Investigative Site
    • Jiangsu
      • Nanjing, Jiangsu, Chiny, 210002
        • Novartis Investigative Site
      • Suzhou, Jiangsu, Chiny, 215006
        • Novartis Investigative Site
    • Liaoning
      • Shenyang, Liaoning, Chiny
        • Novartis Investigative Site
    • Sichuan
      • Chengdu, Sichuan, Chiny, 610041
        • Novartis Investigative Site
    • Zhejiang
      • Hangzhou, Zhejiang, Chiny, 310016
        • Novartis Investigative Site
  • Federacja Rosyjska
      • Moscow, Federacja Rosyjska, 115478
        • Novartis Investigative Site
      • St. Petersburg, Federacja Rosyjska, 197758
        • Novartis Investigative Site
  • Francja
      • Avignon Cedex, Francja, 84082
        • Novartis Investigative Site
      • Clermont Ferrand cedex 1, Francja, 63003
        • Novartis Investigative Site
      • Clichy, Francja, 92110
        • Novartis Investigative Site
      • Dijon, Francja, 21079
        • Novartis Investigative Site
      • Lyon Cedex 08, Francja, 69373
        • Novartis Investigative Site
      • Marseille cedex 05, Francja, 13385
        • Novartis Investigative Site
      • Montpellier Cedex 5, Francja, 34298
        • Novartis Investigative Site
      • Nice Cedex 2, Francja, 06189
        • Novartis Investigative Site
      • Paris, Francja, 75015
        • Novartis Investigative Site
      • Pessac Cedex, Francja, 33604
        • Novartis Investigative Site
      • Poitiers, Francja, 86000
        • Novartis Investigative Site
      • Reims, Francja, 51092
        • Novartis Investigative Site
      • Rennes Cedex, Francja, 35062
        • Novartis Investigative Site
      • Toulouse Cedex 4, Francja, 31054
        • Novartis Investigative Site
      • Villejuif Cedex, Francja, 94805
        • Novartis Investigative Site
  • Hiszpania
    • Catalunya
      • Barcelona, Catalunya, Hiszpania, 08035
        • Novartis Investigative Site
  • Holandia
      • Amsterdam, Holandia, 1105 AZ
        • Novartis Investigative Site
  • Hongkong
      • Hong Kong SAR, Hongkong
        • Novartis Investigative Site
  • Izrael
      • Jerusalem, Izrael, 9112001
        • Novartis Investigative Site
      • Petach Tikva, Izrael, 49100
        • Novartis Investigative Site
      • Ramat Gan, Izrael, 5266202
        • Novartis Investigative Site
      • Rehovot, Izrael, 76100
        • Novartis Investigative Site
  • Japonia
    • Aichi
      • Nagoya, Aichi, Japonia, 464-8681
        • Novartis Investigative Site
    • Chiba
      • Kashiwa, Chiba, Japonia, 277-8577
        • Novartis Investigative Site
    • Ehime
      • Matsuyama, Ehime, Japonia, 791-0280
        • Novartis Investigative Site
    • Fukuoka
      • Fukuoka-city, Fukuoka, Japonia, 812-8582
        • Novartis Investigative Site
    • Hokkaido
      • Sapporo-city, Hokkaido, Japonia, 060-8648
        • Novartis Investigative Site
    • Kanagawa
      • Sagamihara, Kanagawa, Japonia, 252-0380
        • Novartis Investigative Site
    • Miyagi
      • Sendai-city, Miyagi, Japonia, 980-8574
        • Novartis Investigative Site
    • Osaka
      • OsakaSayama, Osaka, Japonia, 589-8511
        • Novartis Investigative Site
      • Takatsuki-city, Osaka, Japonia, 569-8686
        • Novartis Investigative Site
    • Saitama
      • Kitaadachi-gun, Saitama, Japonia, 362-0806
        • Novartis Investigative Site
    • Tochigi
      • Utsunomiya, Tochigi, Japonia, 320-0834
        • Novartis Investigative Site
    • Tokyo
      • Chuo-ku, Tokyo, Japonia, 104-0045
        • Novartis Investigative Site
      • Koto, Tokyo, Japonia, 135-8550
        • Novartis Investigative Site
      • Mitaka-city, Tokyo, Japonia, 181-8611
        • Novartis Investigative Site
  • Kanada
    • British Columbia
      • North Vancouver, British Columbia, Kanada, V7L 2L7
        • Novartis Investigative Site
      • Vancouver, British Columbia, Kanada, V5Z 4E6
        • Novartis Investigative Site
    • Ontario
      • Toronto, Ontario, Kanada, M4N 3M5
        • Novartis Investigative Site
      • Toronto, Ontario, Kanada, M5B 1W8
        • Novartis Investigative Site
    • Quebec
      • Montreal, Quebec, Kanada, H3G 1A4
        • Novartis Investigative Site
      • Sherbrooke, Quebec, Kanada, J1H 5N4
        • Novartis Investigative Site
  • Meksyk
    • Distrito Federal
      • México, Distrito Federal, Meksyk, 14080
        • Novartis Investigative Site
    • Guanajuato
      • León, Guanajuato, Meksyk, 37000
        • Novartis Investigative Site
  • Niemcy
      • Berlin, Niemcy, 13353
        • Novartis Investigative Site
      • Bielefeld, Niemcy, 33604
        • Novartis Investigative Site
      • Frankfurt, Niemcy, 60488
        • Novartis Investigative Site
      • Mainz, Niemcy, 55131
        • Novartis Investigative Site
      • München, Niemcy, 81675
        • Novartis Investigative Site
      • Offenburg, Niemcy, 77652
        • Novartis Investigative Site
      • Trier, Niemcy, 54290
        • Novartis Investigative Site
    • Baden-Württemberg
      • Mannheim, Baden-Württemberg, Niemcy, 68305
        • Novartis Investigative Site
  • Nowa Zelandia
      • Auckland, Nowa Zelandia
        • Novartis Investigative Site
  • Peru
    • Lima
      • San Borja, Lima, Peru, 41
        • Novartis Investigative Site
      • San Isidro, Lima, Peru, 27
        • Novartis Investigative Site
  • Republika Korei
      • Seoul, Republika Korei, 136-705
        • Novartis Investigative Site
      • Taegu, Republika Korei, 700 - 721
        • Novartis Investigative Site
    • Jeollabuk-do
      • Jeonju-si, Jeollabuk-do, Republika Korei, 561-712
        • Novartis Investigative Site
    • Korea
      • Seoul, Korea, Republika Korei, 05505
        • Novartis Investigative Site
      • Seoul, Korea, Republika Korei, 06351
        • Novartis Investigative Site
      • Seoul, Korea, Republika Korei, 110 744
        • Novartis Investigative Site
      • Seoul, Korea, Republika Korei, 03722
        • Novartis Investigative Site
  • Stany Zjednoczone
    • Arkansas
      • Fayetteville, Arkansas, Stany Zjednoczone, 72703
        • Highlands Oncology Group DeptofHighlandsOncologyGrp(2)
    • California
      • Redlands, California, Stany Zjednoczone, 92374
        • Loma Linda Oncology Medical Group Loma Linda
    • Michigan
      • Detroit, Michigan, Stany Zjednoczone, 48202-2689
        • Henry Ford Hospital Dept. of Henry Ford Hospital
    • Minnesota
      • Minneapolis, Minnesota, Stany Zjednoczone, 55455
        • University of Minnesota Cancer Center
    • Texas
      • Dallas, Texas, Stany Zjednoczone, 75390-8527
        • University of Texas Southwestern Medical Center DeptofSimmons Cancer Center(4)
      • Fort Worth, Texas, Stany Zjednoczone, 76104
        • The Center for Cancer and Blood Disorders Dept. of The Ctr for C & BD(2)
      • Houston, Texas, Stany Zjednoczone, 77030-4009
        • University of Texas/MD Anderson Cancer Center Gastrointestinal Med. Oncology
    • Washington
      • Seattle, Washington, Stany Zjednoczone, 98109-1023
        • University of Washington Cancer Care Seattle Cancer Alliance
  • Tajlandia
      • Bangkok, Tajlandia, 10700
        • Novartis Investigative Site
      • Bangkok, Tajlandia, 10400
        • Novartis Investigative Site
      • Songkla, Tajlandia, 90110
        • Novartis Investigative Site
  • Tajwan
      • Liouying Township, Tajwan
        • Novartis Investigative Site
      • Niaosong Township, Tajwan, 83301
        • Novartis Investigative Site
      • Taipei, Tajwan, 10048
        • Novartis Investigative Site
      • Taipei, Tajwan
        • Novartis Investigative Site
    • Taoyuan/ Taiwan ROC
      • Kuei-Shan Chiang, Taoyuan/ Taiwan ROC, Tajwan, 33305
        • Novartis Investigative Site
  • Włochy
      • Frattamaggiore, Włochy, 80020
        • Novartis Investigative Site
    • FI
      • Firenze, FI, Włochy, 50134
        • Novartis Investigative Site
    • MI
      • Rozzano, MI, Włochy, 20089
        • Novartis Investigative Site
    • MO
      • Modena, MO, Włochy, 41100
        • Novartis Investigative Site
    • PN
      • Aviano, PN, Włochy, 33081
        • Novartis Investigative Site
  • Zjednoczone Królestwo
      • East Yorkshire, Zjednoczone Królestwo, HU16 5JQ
        • Novartis Investigative Site
      • London, Zjednoczone Królestwo, SW3 6JJ
        • Novartis Investigative Site
      • London, Zjednoczone Królestwo, WC1E 6HX
        • Novartis Investigative Site
      • Manchester, Zjednoczone Królestwo, M20 4BX
        • Novartis Investigative Site
      • Wolverhampton, Zjednoczone Królestwo, WV10 0QP
        • Novartis Investigative Site
    • Middlesex
      • Northwood, Middlesex, Zjednoczone Królestwo, HA6 2RN
        • Novartis Investigative Site
    • Surrey
      • Sutton, Surrey, Zjednoczone Królestwo, SM2 5PT
        • Novartis Investigative Site

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion Criteria:

  • Male or female patients > 18 years old
  • Histologically or cytologically confirmed and documented gastric adenocarcinoma
  • Documented progression after 1 or 2 prior chemotherapy treatments for advanced disease
  • ECOG Performance Status of < 2
  • Lab parameters within specifically defined intervals
  • Able to provide written informed consent

Exclusion Criteria:

  • Patients who have received > 2 prior systemic therapies for advanced disease
  • Administration of another anticancer therapy within 3 weeks prior to randomization
  • Chronic treatment with steroids or another immunosuppressive agent
  • Major surgery within 2 weeks prior to randomization
  • Patients with CNS metastases
  • Any other severe and/or uncontrolled medical condition

Other protocol-defined inclusion/exclusion criteria may apply

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Poczwórny

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Everolimus + BSC
All patients were randomized to receive everolimus + BSC. All patients orally took two 5 mg tablets of everolimus once daily. Therefore, all patients in the everolimus arm took a total daily dose of 10 mg. Best supportive care was in accordance with the local practice of an individual institution or center, and specifically excluded anti-cancer treatments.
Lek: Everolimus
Everolimus was formulated as tablets of 5 mg strength. In both treatment arms, the study drug was given by continuous oral daily dosing of 10 mg (2 tablets x 5 mg) each morning.
Inne nazwy:
  • RAD001
Lek: Best Supportive Care (BSC)
Best supportive care is defined as care in accordance with the local practice of an individual institution or center, specifically excluding anti-cancer treatments.
Komparator placebo: Placebo + BSC
All patients were randomized to receive placebo + BSC. All patients orally took two 5 mg tablets of matching placebo once daily. Therefore, all patients in the placebo receive matching tablets of total daily dose of 10 mg. Best supportive care was in accordance with the local practice of an individual institution or center, and specifically excluded anti-cancer treatments.
Lek: Best Supportive Care (BSC)
Best supportive care is defined as care in accordance with the local practice of an individual institution or center, specifically excluding anti-cancer treatments.
Lek: Everolimus placebo
Placebo was formulated to be indistinguishable from the everolimus tablets, also formulated as tablets of 5 mg strength. In both treatment arms, the study drug was given by continuous oral daily dosing of 10 mg (2 tablets x 5 mg) each morning.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Overall Survival (OS)
Ramy czasowe: 2.5 years
The primary objective of this study was to compare OS between everolimus + best supportive care (BSC) and placebo + BSC. OS, was defined as the time from date of randomization to the date of death due to any cause. If at the analysis cut-off date a patient was not known to have died, survival was censored at the date of the last contact. OS was analyzed using the Kaplan Meier estimates method.
2.5 years

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Progression Free Survival (PFS)
Ramy czasowe: 2.5 years
Progression free survival was defined as the time from the date of randomization to the date of the first documented disease progression or death due to any cause, where progression was based on Investigator assessment of baseline and post-baseline scans according to RECIST. Progression free survival was censored if no PFS event was observed before the first to occur out of (i) the cut-off date, or (ii) the date when a further anticancer therapy was started. The censoring date was the date of the last adequate tumor assessment before either of these two events occurred. If a PFS event was observed after two or more missing or non-evaluable tumor assessments, then the date of progression was censored at the date of the last adequate tumor assessment; for a PFS event observed after a single missing or non-evaluable tumor assessment, the actual date of disease progression was used. Anslsis was done using Kaplan-Meier estimates method.
2.5 years
Patient Reported Outcome (PRO): Time to Definitive Deterioration of European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30 (EORTC QLQ-C30) Scores
Ramy czasowe: 2.5 years
The EORTC QLQ-C30 global health status/quality of life sub-scale (QL) was pre-specified as the primary domain of interest, followed by physical functioning (PF), social functioning (SF) and emotional functioning (EF).The EORTC QLQ-C30 questionnaire, along with a module specific for gastric cancer patients (EORTC QLQ-STO22), was used to evaluate PRO. The QLQ-C30 has five function scales (physical, role, cognitive, emotional and social), three symptom scales (fatigue, pain and nausea/vomiting) and a global health status/quality of life scale. In addition, there are questions that assess specific symptoms. The QLQ-STO22 consists of 22 questions that make up five multi-item scales (dysphagia, pain, reflux, eating and anxiety) and four single-item scales (dry mouth, tasting, body image and hair loss).
2.5 years
Time to Definitive Deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score
Ramy czasowe: 2.5 years
The ECOG PS scale was used to classify patients according to their functional impairment, with scores ranging from 0 (fully active) to 5 (dead). An analysis of the time to definitive deterioration of the ECOG PS by one category of the score from baseline was performed. Definitive deterioration was defined as a definitive increase by one category from baseline in ECOG PS, with no later improvements observed during the course of the study. A single measure reporting an increase in ECOG PS is sufficient to consider it as a definitive worsening only if it was the last one available for the patient. Kaplan-Meier method was used to estimate the distribution function of time to definitive worsening.
2.5 years
Overall Response Rate (ORR)
Ramy czasowe: 2.5 years
ORR was defined as the proportion of patients with measurable disease in whom best overall response (OR) was either complete response (CR) or partial response (PR) according to RECIST criteria.
2.5 years
Everolimus Steady State Concentraions at Predose (Cmin) and Cmax at Week 5
Ramy czasowe: Week 5
Cmin is the minimum (trough) steady-state drug concentration in the blood during multiple dosing and Cmax is the maximum (peak) blood drug concentration after dose administration. Cmax is estimated as the maximum of C1h and C2H. C1h is 1 hour post-dose blood concentration and C2h is 2 hour post-dose blood concentration. Only valid pre-dose (Cmin), C1h, and C2h everolimus samples were included in the analysis. Valid pre-dose samples were confirmed blood samples collected at steady-state, collected immediately prior to dosing on the same study day, and collected at approximately 24 ± 4 hours after the previous dose and with no vomiting within the first 4 hours following the last dose. Valid C1h and C2h samples were confirmed blood samples collected at steady-state and within ± 1 hour window and with no vomiting within the first 4 hours following the current and previous dose.
Week 5
Everolimus Steady State Concentraions at Predose (Cmin) and Cmax by Region Asia vs. Rest of the World (ROW) at Week 5
Ramy czasowe: Week 5
Cmin is the minimum (trough) steady-state drug concentration in the blood during multiple dosing and Cmax is the maximum (peak) blood drug concentration after dose administration. Cmax is estimated as the maximum of C1h and C2H. C1h is 1 hour post-dose blood concentration and C2h is 2 hour post-dose blood concentration. Only valid pre-dose (Cmin), C1h, and C2h everolimus samples were included in the analysis. Valid pre-dose samples were confirmed blood samples collected at steady-state, collected immediately prior to dosing on the same study day, and collected at approximately 24 ± 4 hours after the previous dose and with no vomiting within the first 4 hours following the last dose. Valid C1h and C2h samples were confirmed blood samples collected at steady-state and within ± 1 hour window and with no vomiting within the first 4 hours following the current and previous dose.
Week 5

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Novartis Pharmaceuticals

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 lipca 2009

Zakończenie podstawowe (Rzeczywisty)

1 stycznia 2014

Ukończenie studiów (Rzeczywisty)

1 stycznia 2014

Daty rejestracji na studia

Pierwszy przesłany

8 kwietnia 2009

Pierwszy przesłany, który spełnia kryteria kontroli jakości

9 kwietnia 2009

Pierwszy wysłany (Oszacować)

10 kwietnia 2009

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Oszacować)

3 listopada 2015

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

8 października 2015

Ostatnia weryfikacja

1 października 2015

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • CRAD001R2301
  • 2008-006544-20 (Numer EudraCT)

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na Zaawansowany rak żołądka

Badania kliniczne na Everolimus

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Sponsorzy i współpracownicy

Warunki medyczne

Interwencje lekowe

CROs by country

CROs in Rwanda

Warunki

Rzadkie choroby

Interwencje lekowe

Suplementy diety

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Lokalizacje

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