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Safety and Efficacy of RAD001 (Everolimus) Monotherapy Plus Best Supportive Care in Patients With Advanced Gastric Cancer (AGC) (GRANITE-1)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00879333
First received: April 8, 2009
Last updated: November 14, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Advanced Gastric Cancer
 Drug: Everolimus
Drug: everolimus placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Compare Overall Survival in RAD vs. Placebo group [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Compare PFS in RAD vs. Placebo group [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
  • Compare QOL in RAD vs. Placebo group [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
  • Compare time to deterioration of ECOG PS in RAD vs. Placebo group [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
  • Compare Cmin and Cmax between patients with and without gastrectomy [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
  • Compare exposure levels (Cmin and Cmax) of Asia vs. ROW gastric cancer patients [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]

Enrollment: 648
Study Start Date: July 2009
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 RAD001 Drug: Everolimus
Placebo Comparator: 2 Placebo Drug: everolimus placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00879333

  Show 122 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Additional Information:
Visit NovartisClinicalTrials.com: Pre-qualify for a trial, and view a list of trials and participating study centers.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00879333     History of Changes
Other Study ID Numbers: CRAD001R2301, 2008-006544-20
Study First Received: April 8, 2009
Last Updated: November 14, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Israel: Ministry of Health
Russia: Pharmacological Committee, Ministry of Health
Mexico: Ministry of Health
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Brazil: Ministry of Health
Venezuela: Ministry of Health and Social Development
Argentina: Ministry of Health
China: Ministry of Health
Japan: Pharmaceuticals and Medical Devices Agency
Korea: Food and Drug Administration
Taiwan: Department of Health
Thailand: Food and Drug Administration
Hong Kong: Department of Health
Australia: Department of Health and Ageing Therapeutic Goods Administration
New Zealand: Medsafe

Keywords provided by Novartis:
Gastric cancer,
advanced gastric cancer,
stomach neoplasm,
 stomach disease,
adenocarcinoma of stomach,
GI neoplasm

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Everolimus
Sirolimus
 Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Antifungal Agents
Anti-Infective Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on June 17, 2013