Clinical trial NCT00879333: Safety and Efficacy of RAD001 (Everolimus) Monotherapy Plus Best Supportive Care in Patients With Advanced Gastric Cancer (AGC)
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Advanced Gastric Cancer
Keywords: Gastric cancer,
advanced gastric cancer,
stomach neoplasm,
stomach disease,
adenocarcinoma of stomach,
GI neoplasm
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-04-10
Enrollment: 656
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: 2.5 years
Secondary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: 2.5 years
measure: 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
timeFrame: 2.5 years
measure: Time to Definitive Deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score
timeFrame: 2.5 years
measure: Overall Response Rate (ORR)
timeFrame: 2.5 years
measure: Everolimus Steady State Concentraions at Predose (Cmin) and Cmax at Week 5
timeFrame: Week 5
measure: Everolimus Steady State Concentraions at Predose (Cmin) and Cmax by Region Asia vs. Rest of the World (ROW) at Week 5
timeFrame: Week 5
Other outcomes:
Locations:
city: Fayetteville
country: United States
facility: Highlands Oncology Group DeptofHighlandsOncologyGrp(2)
state: Arkansas
city: Redlands
country: United States
facility: Loma Linda Oncology Medical Group Loma Linda
state: California
city: Detroit
country: United States
facility: Henry Ford Hospital Dept. of Henry Ford Hospital
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota Cancer Center
state: Minnesota
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center DeptofSimmons Cancer Center(4)
state: Texas
city: Fort Worth
country: United States
facility: The Center for Cancer and Blood Disorders Dept. of The Ctr for C & BD(2)
state: Texas
city: Houston
country: United States
facility: University of Texas/MD Anderson Cancer Center Gastrointestinal Med. Oncology
state: Texas
city: Seattle
country: United States
facility: University of Washington Cancer Care Seattle Cancer Alliance
state: Washington
city: Rio Negro
country: Argentina
facility: Novartis Investigative Site
state: Viedma
city: Buenos Aires
country: Argentina
facility: Novartis Investigative Site
city: Cordoba
country: Argentina
facility: Novartis Investigative Site
city: Canberra
country: Australia
facility: Novartis Investigative Site
state: Australian Capital Territory
city: Herston
country: Australia
facility: Novartis Investigative Site
state: Queensland
city: Kurralta Park
country: Australia
facility: Novartis Investigative Site
state: South Australia
city: North Adelaide
country: Australia
facility: Novartis Investigative Site
state: South Australia
city: Box Hill
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Clayton
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Footscray
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Heidelberg
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Prahran
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Charleroi
country: Belgium
facility: Novartis Investigative Site
city: Gent
country: Belgium
facility: Novartis Investigative Site
city: Leuven
country: Belgium
facility: Novartis Investigative Site
city: Liege
country: Belgium
facility: Novartis Investigative Site
city: North Vancouver
country: Canada
facility: Novartis Investigative Site
state: British Columbia
city: Vancouver
country: Canada
facility: Novartis Investigative Site
state: British Columbia
city: Toronto
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Toronto
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Montreal
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Sherbrooke
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Guangzhou
country: China
facility: Novartis Investigative Site
state: Guangdong
city: Shijiazhuang
country: China
facility: Novartis Investigative Site
state: Hebei
city: Harbin
country: China
facility: Novartis Investigative Site
state: Heilongjiang
city: Nanjing
country: China
facility: Novartis Investigative Site
state: Jiangsu
city: Suzhou
country: China
facility: Novartis Investigative Site
state: Jiangsu
city: Shenyang
country: China
facility: Novartis Investigative Site
state: Liaoning
city: Chengdu
country: China
facility: Novartis Investigative Site
state: Sichuan
city: Hangzhou
country: China
facility: Novartis Investigative Site
state: Zhejiang
city: Beijing
country: China
facility: Novartis Investigative Site
city: Beijing
country: China
facility: Novartis Investigative Site
city: Guangzhou
country: China
facility: Novartis Investigative Site
city: Shanghai
country: China
facility: Novartis Investigative Site
city: Shanghai
country: China
facility: Novartis Investigative Site
city: Shanghai
country: China
facility: Novartis Investigative Site
city: Avignon Cedex
country: France
facility: Novartis Investigative Site
city: Clermont Ferrand cedex 1
country: France
facility: Novartis Investigative Site
city: Clichy
country: France
facility: Novartis Investigative Site
city: Dijon
country: France
facility: Novartis Investigative Site
city: Lyon Cedex 08
country: France
facility: Novartis Investigative Site
city: Marseille cedex 05
country: France
facility: Novartis Investigative Site
city: Montpellier Cedex 5
country: France
facility: Novartis Investigative Site
city: Nice Cedex 2
country: France
facility: Novartis Investigative Site
city: Paris
country: France
facility: Novartis Investigative Site
city: Pessac Cedex
country: France
facility: Novartis Investigative Site
city: Poitiers
country: France
facility: Novartis Investigative Site
city: Reims
country: France
facility: Novartis Investigative Site
city: Rennes Cedex
country: France
facility: Novartis Investigative Site
city: Toulouse Cedex 4
country: France
facility: Novartis Investigative Site
city: Villejuif Cedex
country: France
facility: Novartis Investigative Site
city: Mannheim
country: Germany
facility: Novartis Investigative Site
state: Baden-Württemberg
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Bielefeld
country: Germany
facility: Novartis Investigative Site
city: Frankfurt
country: Germany
facility: Novartis Investigative Site
city: Mainz
country: Germany
facility: Novartis Investigative Site
city: München
country: Germany
facility: Novartis Investigative Site
city: Offenburg
country: Germany
facility: Novartis Investigative Site
city: Trier
country: Germany
facility: Novartis Investigative Site
city: Hong Kong SAR
country: Hong Kong
facility: Novartis Investigative Site
city: Jerusalem
country: Israel
facility: Novartis Investigative Site
city: Petach Tikva
country: Israel
facility: Novartis Investigative Site
city: Ramat Gan
country: Israel
facility: Novartis Investigative Site
city: Rehovot
country: Israel
facility: Novartis Investigative Site
city: Firenze
country: Italy
facility: Novartis Investigative Site
state: FI
city: Rozzano
country: Italy
facility: Novartis Investigative Site
state: MI
city: Modena
country: Italy
facility: Novartis Investigative Site
state: MO
city: Aviano
country: Italy
facility: Novartis Investigative Site
state: PN
city: Frattamaggiore
country: Italy
facility: Novartis Investigative Site
city: Nagoya
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Kashiwa
country: Japan
facility: Novartis Investigative Site
state: Chiba
city: Matsuyama
country: Japan
facility: Novartis Investigative Site
state: Ehime
city: Fukuoka-city
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Sapporo-city
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Sagamihara
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Sendai-city
country: Japan
facility: Novartis Investigative Site
state: Miyagi
city: OsakaSayama
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Takatsuki-city
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Kitaadachi-gun
country: Japan
facility: Novartis Investigative Site
state: Saitama
city: Utsunomiya
country: Japan
facility: Novartis Investigative Site
state: Tochigi
city: Chuo-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Koto
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Mitaka-city
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Jeonju-si
country: Korea, Republic of
facility: Novartis Investigative Site
state: Jeollabuk-do
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
state: Korea
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
state: Korea
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
state: Korea
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
state: Korea
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Taegu
country: Korea, Republic of
facility: Novartis Investigative Site
city: México
country: Mexico
facility: Novartis Investigative Site
state: Distrito Federal
city: León
country: Mexico
facility: Novartis Investigative Site
state: Guanajuato
city: Amsterdam
country: Netherlands
facility: Novartis Investigative Site
city: Auckland
country: New Zealand
facility: Novartis Investigative Site
city: San Borja
country: Peru
facility: Novartis Investigative Site
state: Lima
city: San Isidro
country: Peru
facility: Novartis Investigative Site
state: Lima
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: St. Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Kuei-Shan Chiang
country: Taiwan
facility: Novartis Investigative Site
state: Taoyuan/ Taiwan ROC
city: Liouying Township
country: Taiwan
facility: Novartis Investigative Site
city: Niaosong Township
country: Taiwan
facility: Novartis Investigative Site
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
city: Bangkok
country: Thailand
facility: Novartis Investigative Site
city: Bangkok
country: Thailand
facility: Novartis Investigative Site
city: Songkla
country: Thailand
facility: Novartis Investigative Site
city: Northwood
country: United Kingdom
facility: Novartis Investigative Site
state: Middlesex
city: Sutton
country: United Kingdom
facility: Novartis Investigative Site
state: Surrey
city: East Yorkshire
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
city: Manchester
country: United Kingdom
facility: Novartis Investigative Site
city: Wolverhampton
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Ohtsu A, Ajani JA, Bai YX, Bang YJ, Chung HC, Pan HM, Sahmoud T, Shen L, Yeh KH, Chin K, Muro K, Kim YH, Ferry D, Tebbutt NC, Al-Batran SE, Smith H, Costantini C, Rizvi S, Lebwohl D, Van Cutsem E. Everolimus for previously treated advanced gastric cancer: results of the randomized, double-blind, phase III GRANITE-1 study. J Clin Oncol. 2013 Nov 1;31(31):3935-43. doi: 10.1200/JCO.2012.48.3552. Epub 2013 Sep 16.