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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Brief Summary

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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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Detailed Description

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Conditions

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Advanced Gastric Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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RAD001

Group Type EXPERIMENTAL

Everolimus

Intervention Type DRUG

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

Interventions

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Everolimus

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No