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

Completed · Phase 3 · Has a placebo group

Conditions studied: Advanced Gastric Cancer

In brief

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.

Key facts

Study ID

NCT00879333

Run by

Novartis Pharmaceuticals

People needed

656

Starts

2009-07-01

Expected to finish

2014-01-01

Last updated by the study team

2015-11-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Loma Linda Oncology Medical Group Loma Linda — Redlands, California, United States
• Henry Ford Hospital Dept. of Henry Ford Hospital — Detroit, Michigan, United States
• University of Minnesota Cancer Center — Minneapolis, Minnesota, United States
• University of Texas Southwestern Medical Center DeptofSimmons Cancer Center(4) — Dallas, Texas, United States
• The Center for Cancer and Blood Disorders Dept. of The Ctr for C & BD(2) — Fort Worth, Texas, United States
• University of Texas/MD Anderson Cancer Center Gastrointestinal Med. Oncology — Houston, Texas, United States
• University of Washington Cancer Care Seattle Cancer Alliance — Seattle, Washington, United States
• Novartis Investigative Site — Buenos Aires, Buenos Aires, Argentina
• Novartis Investigative Site — Córdoba, Córdoba Province, Argentina
• Novartis Investigative Site — Rio Negro, Viedma, Argentina
• Novartis Investigative Site — Canberra, Australian Capital Territory, Australia
• Novartis Investigative Site — Herston, Queensland, Australia
• Novartis Investigative Site — Kurralta Park, South Australia, Australia
• Novartis Investigative Site — North Adelaide, South Australia, Australia
• Novartis Investigative Site — Box Hill, Victoria, Australia
• Novartis Investigative Site — Clayton, Victoria, Australia
• Novartis Investigative Site — Footscray, Victoria, Australia
• Novartis Investigative Site — Heidelberg, Victoria, Australia
• Novartis Investigative Site — Prahran, Victoria, Australia
• Novartis Investigative Site — Charleroi, Belgium
• Novartis Investigative Site — Ghent, Belgium
• Novartis Investigative Site — Leuven, Belgium
• Novartis Investigative Site — Liège, Belgium
• Novartis Investigative Site — North Vancouver, British Columbia, Canada
• Highlands Oncology Group DeptofHighlandsOncologyGrp(2) — Fayetteville, Arkansas, United States

Full record on ClinicalTrials.gov

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