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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00879333




Registration number
NCT00879333
Ethics application status
Date submitted
8/04/2009
Date registered
10/04/2009
Date last updated
3/11/2015

Titles & IDs
Public title
Safety and Efficacy of RAD001 (Everolimus) Monotherapy Plus Best Supportive Care in Patients With Advanced Gastric Cancer (AGC)
Scientific title
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
Secondary ID [1] 0 0
2008-006544-20
Secondary ID [2] 0 0
CRAD001R2301
Universal Trial Number (UTN)
Trial acronym
GRANITE-1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Gastric Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Stomach

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Everolimus
Treatment: Drugs - Everolimus placebo
Treatment: Drugs - Best Supportive Care (BSC)

Experimental: 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.

Placebo comparator: 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.


Treatment: Drugs: 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.

Treatment: Drugs: 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.

Treatment: Drugs: 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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
2.5 years
Secondary outcome [1] 0 0
Progression Free Survival (PFS)
Timepoint [1] 0 0
2.5 years
Secondary outcome [2] 0 0
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
Timepoint [2] 0 0
2.5 years
Secondary outcome [3] 0 0
Time to Definitive Deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score
Timepoint [3] 0 0
2.5 years
Secondary outcome [4] 0 0
Overall Response Rate (ORR)
Timepoint [4] 0 0
2.5 years
Secondary outcome [5] 0 0
Everolimus Steady State Concentraions at Predose (Cmin) and Cmax at Week 5
Timepoint [5] 0 0
Week 5
Secondary outcome [6] 0 0
Everolimus Steady State Concentraions at Predose (Cmin) and Cmax by Region Asia vs. Rest of the World (ROW) at Week 5
Timepoint [6] 0 0
Week 5

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2014
Sample size
Target
Accrual to date
Final
656
Recruitment in Australia
Recruitment state(s)
ACT,QLD,SA,VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Canberra
Recruitment hospital [2] 0 0
Novartis Investigative Site - Herston
Recruitment hospital [3] 0 0
Novartis Investigative Site - Kurralta Park
Recruitment hospital [4] 0 0
Novartis Investigative Site - North Adelaide
Recruitment hospital [5] 0 0
Novartis Investigative Site - Box Hill
Recruitment hospital [6] 0 0
Novartis Investigative Site - Clayton
Recruitment hospital [7] 0 0
Novartis Investigative Site - Footscray
Recruitment hospital [8] 0 0
Novartis Investigative Site - Heidelberg
Recruitment hospital [9] 0 0
Novartis Investigative Site - Prahran
Recruitment postcode(s) [1] 0 0
2605 - Canberra
Recruitment postcode(s) [2] 0 0
4029 - Herston
Recruitment postcode(s) [3] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [4] 0 0
5006 - North Adelaide
Recruitment postcode(s) [5] 0 0
3128 - Box Hill
Recruitment postcode(s) [6] 0 0
3168 - Clayton
Recruitment postcode(s) [7] 0 0
3011 - Footscray
Recruitment postcode(s) [8] 0 0
3084 - Heidelberg
Recruitment postcode(s) [9] 0 0
3181 - Prahran
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
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United States of America
State/province [2] 0 0
California
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United States of America
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Michigan
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United States of America
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Minnesota
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United States of America
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Texas
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United States of America
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Washington
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Argentina
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Viedma
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Argentina
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Buenos Aires
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Argentina
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Cordoba
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Belgium
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Charleroi
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Belgium
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Gent
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Belgium
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Leuven
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Belgium
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Liege
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Canada
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British Columbia
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Canada
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Ontario
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Canada
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Quebec
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China
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Guangdong
Country [18] 0 0
China
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Hebei
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China
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Heilongjiang
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China
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Jiangsu
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China
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Liaoning
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China
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Sichuan
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China
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Zhejiang
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China
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Beijing
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China
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Guangzhou
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China
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Shanghai
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France
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Avignon Cedex
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France
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Clermont Ferrand cedex 1
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France
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Clichy
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France
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Dijon
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France
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Lyon Cedex 08
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France
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Marseille cedex 05
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France
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Montpellier Cedex 5
Country [34] 0 0
France
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Nice Cedex 2
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France
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Paris
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France
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Pessac Cedex
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France
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Poitiers
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France
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Reims
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France
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Rennes Cedex
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France
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Toulouse Cedex 4
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France
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Villejuif Cedex
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Germany
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Baden-Württemberg
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Germany
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Berlin
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Germany
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Bielefeld
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Germany
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Frankfurt
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Germany
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Mainz
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Germany
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München
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Germany
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Offenburg
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Germany
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Trier
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Hong Kong
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Hong Kong SAR
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Israel
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Jerusalem
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Israel
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Petach Tikva
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Israel
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Ramat Gan
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Israel
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Rehovot
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Italy
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FI
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Italy
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MI
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Italy
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MO
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Italy
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PN
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Italy
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Frattamaggiore
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Japan
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Aichi
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Japan
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Chiba
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Ehime
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Fukuoka
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Hokkaido
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Japan
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Kanagawa
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Japan
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Miyagi
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Japan
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Osaka
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Japan
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Saitama
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Japan
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Tochigi
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Japan
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Tokyo
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Korea, Republic of
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Jeollabuk-do
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Korea
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Korea, Republic of
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Seoul
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Korea, Republic of
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Taegu
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Mexico
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Distrito Federal
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Mexico
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Guanajuato
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Netherlands
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Amsterdam
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New Zealand
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Auckland
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Peru
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Lima
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Russian Federation
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Moscow
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Russian Federation
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St. Petersburg
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Spain
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Catalunya
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Taiwan
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Taoyuan/ Taiwan ROC
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Taiwan
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Liouying Township
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Taiwan
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Niaosong Township
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Taiwan
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Taipei
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Thailand
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Bangkok
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Thailand
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Songkla
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United Kingdom
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Middlesex
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United Kingdom
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Surrey
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United Kingdom
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East Yorkshire
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United Kingdom
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London
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United Kingdom
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Manchester
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United Kingdom
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Wolverhampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00879333