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
18 Years
N/A
Open (Enrolling)
Both
Advanced Gastric Cancer
Both
Advanced Gastric Cancer
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 Center | Minneapolis, Minnesota 55455 |
| Highlands Oncology Group DeptofHighlandsOncologyGrp(2) | Fayetteville, Arkansas 72703 |
| University of Washington Cancer Care Seattle Cancer Alliance | Seattle, Washington 98109-1023 |
| MD Anderson Cancer Center/University of Texas Gastrointestinal Med. Oncology | Houston, Texas 77030-4009 |
| Loma Linda Oncology Medical Group Loma Linda | Redlands, California 92374 |
| Henry Ford Hospital Dept. of Henry Ford Hospital | Detroit, 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 |
