Everolimus in Selected Patients With Metastatic Melanoma: Efficacy and Safety Study

April 30, 2015 updated by: Lu Si, Peking University Cancer Hospital & Institute

A Single-armed, Open-labeled and Single-centered Phase II Trial of Everolimus in Selected Patients With Metastatic Melanoma: Efficacy and Safety Study

This is a single-armed, open-labeled and single-centered study of everolimus in selective patients with metastatic melanoma for evaluation of the efficacy and safety. The study objective is to evaluate efficacy profile of everolimus.

The patients who comply with the inclusion and exclusion criteria will be enrolled. The estimated recruiting duration is 18 months. Everolimus will be given in the dose of 10 mg orally each day at lease 6 months unless disease progression or intolerance. The follow-up is till death(at least 1 year).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100142

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Clinical diagnosis of metastases melanoma. Must have evidence of mutations(Kinase domain) of mTOR . Must be ECOG performance status 0,1, or 2 . Must be estimated life expectancy of 3 months or greater. Must be age 18 years or older, male or female. Must have at least one measurable site of disease as defined by at least 1 cm in greatest dimension.

Adequate organ function. Must be willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.

Exclusion Criteria:

Prior systemic therapy for metastatic disease within 4 weeks. Second malignancy within the last 5 years. Severe and/or uncontrolled medical disease. Received RAD001 or other mTOR inhibitors previously . Hypersensitivity to everolimus Current treatment on another clinical trial. Pregnancy or breastfeeding.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Everolimus
Drug: Everolimus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To assess the progression-free survival (PFS) after treatment with everolimus in selected patients with metastatic melanoma (with mTOR mutation).
Time Frame: 18 months
18 months

Secondary Outcome Measures

Outcome Measure
Time Frame
To assess the overall survival (OS) after treatment with everolimus in selected patients with metastatic melanoma (with mTOR mutation).
Time Frame: 18 months
18 months
To evaluate the safety of and tolerability to everolimus in Chinese melanoma patients.
Time Frame: 18 months
18 months
To evaluate the quality of life. Strategic goal: Explore and Capitalize on New Indications.
Time Frame: 18 months
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Cancer Hospital & Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Anticipated)

May 1, 2015

Study Registration Dates

First Submitted

September 24, 2013

First Submitted That Met QC Criteria

October 9, 2013

First Posted (Estimate)

October 11, 2013

Study Record Updates

Last Update Posted (Estimate)

May 1, 2015

Last Update Submitted That Met QC Criteria

April 30, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRAD001CCN28T

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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