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OpenTrials
Completed

NCT Number: NCT00519324

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

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.

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Key information

Conditions

Advanced Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis investigative Site, Aichi, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Everolimus

Drug

10 mg/day (2 tablets of 5 mg each)

Primary outcomes

  1. To Assess disease control rate (DCR) as defined CR + PR + SD assessed by RECIST criteria

    Time frame: 18 months

Secondary outcomes

  1. Objective response rate (ORR) assessed by RECIST criteria

    Time frame: 18 months

  2. To assess progression free survival (PFS) and overall survival (OS)

    Time frame: 18 months

  3. 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

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A Single Arm, Multi-center Phase II Study of RAD001 in Patients With Advanced Gastric Carcinoma Whose Cancer Has Progressed Despite Prior Treatment

Important dates

Study start
2007
Primary completion
2009
First posted
Aug 22, 2007
Registry last updated
Nov 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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