Efficacy and Safety of Everolimus (RAD001) in Patients With Advanced Gastric Cancer
This study has been completed.
Sponsor:
Novartis Pharmaceuticals
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
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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
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 Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Antifungal Agents Anti-Infective Agents Anti-Bacterial Agents |
ClinicalTrials.gov processed this record on May 16, 2013