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

PHASE3CompletedINTERVENTIONAL
Enrollment

656

Participants

Timeline

Start Date

July 31, 2009

Primary Completion Date

January 31, 2014

Study Completion Date

January 31, 2014

Conditions
Advanced Gastric Cancer
Interventions
DRUG

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.

DRUG

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.

DRUG

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.

Trial Locations (122)

27

Novartis Investigative Site, San Isidro

41

Novartis Investigative Site, San Borja

2605

Novartis Investigative Site, Canberra

3000

Novartis Investigative Site, Leuven

3011

Novartis Investigative Site, Footscray

3084

Novartis Investigative Site, Heidelberg

3128

Novartis Investigative Site, Box Hill

3168

Novartis Investigative Site, Clayton

3181

Novartis Investigative Site, Prahran

4000

Novartis Investigative Site, Liège

4029

Novartis Investigative Site, Herston

5006

Novartis Investigative Site, North Adelaide

5037

Novartis Investigative Site, Kurralta Park

6000

Novartis Investigative Site, Charleroi

8500

Novartis Investigative Site, Rio Negro

9000

Novartis Investigative Site, Ghent

10048

Novartis Investigative Site, Taipei

10400

Novartis Investigative Site, Bangkok

10700

Novartis Investigative Site, Bangkok

13353

Novartis Investigative Site, Berlin

13385

Novartis Investigative Site, Marseille

14080

Novartis Investigative Site, Mexico City

20089

Novartis Investigative Site, Rozzano

21079

Novartis Investigative Site, Dijon

31054

Novartis Investigative Site, Toulouse

33081

Novartis Investigative Site, Aviano

33305

Novartis Investigative Site, Kuei-Shan Chiang

33604

Novartis Investigative Site, Pessac

Novartis Investigative Site, Bielefeld

34298

Novartis Investigative Site, Montpellier

35062

Novartis Investigative Site, Rennes

37000

Novartis Investigative Site, León

41100

Novartis Investigative Site, Modena

49100

Novartis Investigative Site, Petah Tikva

50134

Novartis Investigative Site, Florence

51092

Novartis Investigative Site, Reims

54290

Novartis Investigative Site, Trier

55131

Novartis Investigative Site, Mainz

55455

University of Minnesota Cancer Center, Minneapolis

60488

Novartis Investigative Site, Frankfurt

63003

Novartis Investigative Site, Clermont-Ferrand

68305

Novartis Investigative Site, Mannheim

69373

Novartis Investigative Site, Lyon

72703

Highlands Oncology Group DeptofHighlandsOncologyGrp(2), Fayetteville

75015

Novartis Investigative Site, Paris

76100

Novartis Investigative Site, Rehovot

76104

The Center for Cancer and Blood Disorders Dept. of The Ctr for C & BD(2), Fort Worth

77652

Novartis Investigative Site, Offenburg

80020

Novartis Investigative Site, Frattamaggiore

81675

Novartis Investigative Site, München

83301

Novartis Investigative Site, Niaosong Township

84082

Novartis Investigative Site, Avignon

86000

Novartis Investigative Site, Poitiers

90110

Novartis Investigative Site, Songkhla

92110

Novartis Investigative Site, Clichy

92374

Loma Linda Oncology Medical Group Loma Linda, Redlands

94805

Novartis Investigative Site, Villejuif

100036

Novartis Investigative Site, Beijing

100039

Novartis Investigative Site, Beijing

115478

Novartis Investigative Site, Moscow

150081

Novartis Investigative Site, Harbin

197758

Novartis Investigative Site, Saint Petersburg

200003

Novartis Investigative Site, Shanghai

200025

Novartis Investigative Site, Shanghai

200032

Novartis Investigative Site, Shanghai

210002

Novartis Investigative Site, Nanjing

215006

Novartis Investigative Site, Suzhou

310016

Novartis Investigative Site, Hangzhou

510060

Novartis Investigative Site, Guangzhou

510515

Novartis Investigative Site, Guangzhou

610041

Novartis Investigative Site, Chengdu

5266202

Novartis Investigative Site, Ramat Gan

9112001

Novartis Investigative Site, Jerusalem

48202-2689

Henry Ford Hospital Dept. of Henry Ford Hospital, Detroit

75390-8527

University of Texas Southwestern Medical Center DeptofSimmons Cancer Center(4), Dallas

77030-4009

University of Texas/MD Anderson Cancer Center Gastrointestinal Med. Oncology, Houston

98109-1023

University of Washington Cancer Care Seattle Cancer Alliance, Seattle

C1264AAA

Novartis Investigative Site, Buenos Aires

X5000IUG

Novartis Investigative Site, Córdoba

V7L 2L7

Novartis Investigative Site, North Vancouver

V5Z 4E6

Novartis Investigative Site, Vancouver

M4N 3M5

Novartis Investigative Site, Toronto

M5B 1W8

Novartis Investigative Site, Toronto

H3G 1A4

Novartis Investigative Site, Montreal

J1H 5N4

Novartis Investigative Site, Sherbrooke

050011

Novartis Investigative Site, Shijiazhuang

Unknown

Novartis Investigative Site, Shenyang

Novartis Investigative Site, Hong Kong SAR

Novartis Investigative Site, Auckland

Novartis Investigative Site, Liouying Township

Novartis Investigative Site, Taipei

06189

Novartis Investigative Site, Nice

464-8681

Novartis Investigative Site, Nagoya

277-8577

Novartis Investigative Site, Kashiwa

791-0280

Novartis Investigative Site, Matsuyama

812-8582

Novartis Investigative Site, Fukuoka

060-8648

Novartis Investigative Site, Sapporo

252-0380

Novartis Investigative Site, Sagamihara

980-8574

Novartis Investigative Site, Sendai

589-8511

Novartis Investigative Site, Sayama

569-8686

Novartis Investigative Site, Takatsuki

362-0806

Novartis Investigative Site, Kitaadachi-gun

320-0834

Novartis Investigative Site, Utsunomiya

104-0045

Novartis Investigative Site, Chuo-ku

135-8550

Novartis Investigative Site, Koto

181-8611

Novartis Investigative Site, Mitaka

1105 AZ

Novartis Investigative Site, Amsterdam

561-712

Novartis Investigative Site, Jeonju

03722

Novartis Investigative Site, Seoul

05505

Novartis Investigative Site, Seoul

06351

Novartis Investigative Site, Seoul

110 744

Novartis Investigative Site, Seoul

136-705

Novartis Investigative Site, Seoul

700 - 721

Novartis Investigative Site, Taegu

08035

Novartis Investigative Site, Barcelona

HA6 2RN

Novartis Investigative Site, Northwood

SM2 5PT

Novartis Investigative Site, Sutton

HU16 5JQ

Novartis Investigative Site, East Yorkshire

SW3 6JJ

Novartis Investigative Site, London

WC1E 6HX

Novartis Investigative Site, London

M20 4BX

Novartis Investigative Site, Manchester

WV10 0QP

Novartis Investigative Site, Wolverhampton

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY