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

NCT ID: NCT00879333

Last Updated: 2015-11-03

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

656 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2014-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Advanced Gastric Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Everolimus

Intervention Type DRUG

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.

Best Supportive Care (BSC)

Intervention Type DRUG

Best supportive care is defined as care in accordance with the local practice of an individual institution or center, specifically excluding anti-cancer treatments.

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.

Group Type PLACEBO_COMPARATOR

Everolimus placebo

Intervention Type DRUG

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.

Best Supportive Care (BSC)

Intervention Type DRUG

Best supportive care is defined as care in accordance with the local practice of an individual institution or center, specifically excluding anti-cancer treatments.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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RAD001

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Highlands Oncology Group DeptofHighlandsOncologyGrp(2)

Fayetteville, Arkansas, United States

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Loma Linda Oncology Medical Group Loma Linda

Redlands, California, United States

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Henry Ford Hospital Dept. of Henry Ford Hospital

Detroit, Michigan, United States

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University of Minnesota Cancer Center

Minneapolis, Minnesota, United States

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

Dallas, Texas, United States

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

Fort Worth, Texas, United States

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

Houston, Texas, United States

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University of Washington Cancer Care Seattle Cancer Alliance

Seattle, Washington, United States

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Novartis Investigative Site

Buenos Aires, Buenos Aires, Argentina

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Córdoba, Córdoba Province, Argentina

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Rio Negro, Viedma, Argentina

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Canberra, Australian Capital Territory, Australia

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Herston, Queensland, Australia

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Kurralta Park, South Australia, Australia

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North Adelaide, South Australia, Australia

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Box Hill, Victoria, Australia

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Clayton, Victoria, Australia

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Footscray, Victoria, Australia

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Heidelberg, Victoria, Australia

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Prahran, Victoria, Australia

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Charleroi, , Belgium

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Ghent, , Belgium

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Leuven, , Belgium

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Liège, , Belgium

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North Vancouver, British Columbia, Canada

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Vancouver, British Columbia, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Sherbrooke, Quebec, Canada

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Guangzhou, Guangdong, China

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Shijiazhuang, Hebei, China

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Harbin, Heilongjiang, China

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Nanjing, Jiangsu, China

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Suzhou, Jiangsu, China

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Shenyang, Liaoning, China

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Chengdu, Sichuan, China

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Hangzhou, Zhejiang, China

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Beijing, , China

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Beijing, , China

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Guangzhou, , China

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Shanghai, , China

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Shanghai, , China

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Shanghai, , China

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Poitiers, France, France

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Avignon, , France

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Clermont-Ferrand, , France

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Clichy, , France

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Dijon, , France

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Lyon, , France

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Marseille, , France

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Montpellier, , France

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Nice, , France

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Paris, , France

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Pessac, , France

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Reims, , France

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Rennes, , France

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Toulouse, , France

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Villejuif, , France

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Mannheim, Baden-Wurttemberg, Germany

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Mainz, Germany, Germany

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Berlin, , Germany

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Bielefeld, , Germany

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Frankfurt, , Germany

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Offenburg, , Germany

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Trier, , Germany

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Hong Kong SAR, , Hong Kong

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Jerusalem, , Israel

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Petah Tikva, , Israel

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Ramat Gan, , Israel

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Rehovot, , Israel

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Florence, FI, Italy

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Rozzano, MI, Italy

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Modena, MO, Italy

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Aviano, PN, Italy

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Frattamaggiore, , Italy

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Nagoya, Aichi-ken, Japan

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Kashiwa, Chiba, Japan

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Matsuyama, Ehime, Japan

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Fukuoka, Fukuoka, Japan

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Sapporo, Hokkaido, Japan

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Sagamihara, Kanagawa, Japan

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Sendai, Miyagi, Japan

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Sayama, Osaka, Japan

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Takatsuki, Osaka, Japan

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Kitaadachi-gun, Saitama, Japan

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Utsunomiya, Tochigi, Japan

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Chuo-ku, Tokyo, Japan

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Koto, Tokyo, Japan

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Mitaka, Tokyo, Japan

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León, Guanajuato, Mexico

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Mexico City, Mexico City, Mexico

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Amsterdam, , Netherlands

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Auckland, , New Zealand

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San Borja, Lima region, Peru

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San Isidro, Lima region, Peru

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Moscow, , Russia

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Saint Petersburg, , Russia

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Jeonju, Jeollabuk-do, South Korea

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Seoul, Korea, South Korea

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Seoul, , South Korea

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Taegu, , South Korea

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Barcelona, Catalonia, Spain

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Niaosong Township, Taiwan, Taiwan

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Taipei, Taiwan, Taiwan

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Kuei-Shan Chiang, Taoyuan/ Taiwan ROC, Taiwan

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Liouying Township, , Taiwan

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Taipei, , Taiwan

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Bangkok, , Thailand

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Bangkok, , Thailand

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Songkhla, , Thailand

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Northwood, Middlesex, United Kingdom

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Sutton, Surrey, United Kingdom

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East Yorkshire, , United Kingdom

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London, , United Kingdom

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London, , United Kingdom

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Manchester, , United Kingdom

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Wolverhampton, , United Kingdom

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Countries

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United States Argentina Australia Belgium Canada China France Germany Hong Kong Israel Italy Japan Mexico Netherlands New Zealand Peru Russia South Korea Spain Taiwan Thailand United Kingdom

References

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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.

Reference Type DERIVED
PMID: 24043745 (View on PubMed)

Related Links

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http://www.novartisclinicaltrials.com/etrials/searchTrial.do?trialID=717

Visit NovartisClinicalTrials.com: Pre-qualify for a trial, and view a list of trials and participating study centers.

Other Identifiers

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2008-006544-20

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CRAD001R2301

Identifier Type: -

Identifier Source: org_study_id

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