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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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Advanced Gastric Cancer

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Compare Overall Survival in RAD vs. Placebo group

Outcome Time Frame:

2.5 years

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CRAD001R2301

NCT ID:

NCT00879333

Start Date:

July 2009

Completion Date:

December 2012

Related Keywords:

  • Advanced Gastric Cancer
  • Gastric cancer,
  • advanced gastric cancer,
  • stomach neoplasm,
  • stomach disease,
  • adenocarcinoma of stomach,
  • GI neoplasm
  • Stomach Neoplasms

Name

Location

University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
Highlands Oncology Group DeptofHighlandsOncologyGrp(2)Fayetteville, Arkansas  72703
University of Washington Cancer Care Seattle Cancer AllianceSeattle, Washington  98109-1023
MD Anderson Cancer Center/University of Texas Gastrointestinal Med. OncologyHouston, Texas  77030-4009
Loma Linda Oncology Medical Group Loma LindaRedlands, California  92374
Henry Ford Hospital Dept. of Henry Ford HospitalDetroit, Michigan  48202-2689
University of Texas Southwestern Medical Center DeptofSimmons Cancer Center(4)Dallas, Texas  75390-8527
The Center for Cancer and Blood Disorders Dept. of The Ctr for C & BD(2)Fort Worth, Texas  76104