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

Advanced Gastric Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00519324
• Other study ID #: CRAD001C1201
• Status: Completed
• Phase: Phase 2
• First received: August 21, 2007
• Last updated: November 16, 2016
• Start date: August 2007

Study information

• Verified date: November 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• Everolimus
10 mg/day (2 tablets of 5 mg each)

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Japan, 

References & Publications (1)

Doi T, Muro K, Boku N, Yamada Y, Nishina T, Takiuchi H, Komatsu Y, Hamamoto Y, Ohno N, Fujita Y, Robson M, Ohtsu A. Multicenter phase II study of everolimus in patients with previously treated metastatic gastric cancer. J Clin Oncol. 2010 Apr 10;28(11):19 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To Assess disease control rate (DCR) as defined CR + PR + SD assessed by RECIST criteria		18 months	No
Secondary	Objective response rate (ORR) assessed by RECIST criteria		18 months	No
Secondary	To assess progression free survival (PFS) and overall survival (OS)		18 months	No
Secondary	To describe the safety profile (incidence and severity of adverse events, serious adverse events) assessed by NCI CTCAE version 3.0		18 months	No

External Links

•   Results for CRAD001C1201 from the Novartis Clinical Trials website