Efficacy and Safety of Everolimus (RAD001) in Patients With Advanced Gastric Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00519324
First received: August 21, 2007
Last updated: April 24, 2012
Last verified: April 2012
  Purpose

The purpose of this study is to assess the efficacy and safety of everolimus 10mg daily in patients with advanced gastric carcinoma (inoperable, recurrent or metastatic gastric cancer) whose cancer has progressed despite prior treatment.


Condition Intervention Phase
Advanced Gastric Cancer
Drug: Everolimus
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Single Arm, Multi-center Phase II Study of RAD001 in Patients With Advanced Gastric Carcinoma Whose Cancer Has Progressed Despite Prior Treatment

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • To Assess disease control rate (DCR) as defined CR + PR + SD assessed by RECIST criteria [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective response rate (ORR) assessed by RECIST criteria [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • To assess progression free survival (PFS) and overall survival (OS) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • To describe the safety profile (incidence and severity of adverse events, serious adverse events) assessed by NCI CTCAE version 3.0 [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Enrollment: 54
Study Start Date: August 2007
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RAD001 Drug: Everolimus
10 mg/day (2 tablets of 5 mg each)

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Histological proven gastric adenocarcinoma
  • Progressive disease during/ after prior treatment
  • Treated with 1 or 2 chemotherapy regimen for advanced disease
  • At least one measurable lesion by RECIST criteria
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion criteria:

  • History of another primary malignancy within 3 years
  • Treated with 3 or more regimens for advanced gastric cancer
  • Chronic treatment with steroids or another immunosuppressive agent
  • A known history of HIV or hepatitis B seropositive, or active hepatitis C infection
  • Patients with active, bleeding diathesis

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00519324

Locations
Japan
Novartis investigative Site
Aichi, Japan
Novartis investigative Site
Chiba, Japan
Novartis investigative Site
Ehime, Japan
Novartis Investigative Site
Hokkaido, Japan
Novartis investigative Site
Osaka, Japan
Novartis investigative Site
Shizuoka, Japan
Novartis Investigative Site
Tochigi, Japan
Novartis investigative Site
Tokyo, Japan
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00519324     History of Changes
Other Study ID Numbers: CRAD001C1201
Study First Received: August 21, 2007
Last Updated: April 24, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Novartis:
Gastric Cancer
RAD001
mTOR

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
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents

ClinicalTrials.gov processed this record on August 27, 2014