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


Tracking Information

Start Date  ICMJEJune 2009
Estimated Primary Completion DateJune 2011   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: April 9, 2009)		Compare Overall Survival in RAD vs. Placebo group [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
Original Primary Outcome Measures  ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00879333 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: April 9, 2009)
  • 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 ]
Original Secondary Outcome Measures  ICMJESame as current

Descriptive Information

Brief Title  ICMJESafety and Efficacy of RAD001 (Everolimus) Monotherapy Plus Best Supportive Care in Patients With Advanced Gastric Cancer (AGC)
Official Title  ICMJEA 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
Brief Summary

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.

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment
Condition  ICMJEAdvanced Gastric Cancer
Intervention  ICMJE
  • Drug: Everolimus
  • Drug: everolimus placebo
Study Arms / Comparison Groups
  • 1 RAD001: Experimental
    Intervention: Drug: Everolimus
  • 2 Placebo: Placebo Comparator
    Intervention: Drug: everolimus placebo

Recruitment Information

Estimated Enrollment  ICMJE633
Completion Date 
Estimated Primary Completion DateJune 2011   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

GenderBoth
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Novartis Pharmaceuticals+1 800 340 6843
Location Countries  ICMJEUnited States,   Argentina,   Australia,   Belgium,   Brazil,   Canada,   Colombia,   France,   Germany,   Hong Kong,   Israel,   Italy,   Japan,   Korea, Republic of,   Mexico,   Netherlands,   Russian Federation,   Taiwan,   Thailand,   United Kingdom,   Venezuela

Administrative Information

NCT ID  ICMJENCT00879333
Responsible PartyExternal Affairs, Novartis Pharmaceuticals
Study ID Numbers  ICMJECRAD001R2301, EUDRACT No. - 2008-006544-20
Study Sponsor  ICMJENovartis Pharmaceuticals
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Novartis PharmaceuticalsNovartis Pharmaceuticals
Information Provided ByNovartis