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

Primary Purpose

Melanoma, TOR Serine-Threonine Kinases, Neoplasm Metastasis

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Everolimus

About this trial

This is an interventional treatment trial for Melanoma focused on measuring melanoma, TOR Serine-Threonine Kinases

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

LuSiRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Everolimus

Arm Description

Outcomes

Primary Outcome Measures

To assess the progression-free survival (PFS) after treatment with everolimus in selected patients with metastatic melanoma (with mTOR mutation).

Secondary Outcome Measures

To assess the overall survival (OS) after treatment with everolimus in selected patients with metastatic melanoma (with mTOR mutation).

To evaluate the safety of and tolerability to everolimus in Chinese melanoma patients.

To evaluate the quality of life. Strategic goal: Explore and Capitalize on New Indications.

Full Information

NCT ID

NCT01960829

First Posted

September 24, 2013

Last Updated

April 30, 2015

Sponsor

Peking University Cancer Hospital & Institute

1. Study Identification

Unique Protocol Identification Number

NCT01960829

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2015

Overall Recruitment Status

Unknown status

Study Start Date

September 2013 (undefined)

Primary Completion Date

May 2015 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Peking University Cancer Hospital & Institute

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Melanoma, TOR Serine-Threonine Kinases, Neoplasm Metastasis

Keywords

melanoma, TOR Serine-Threonine Kinases

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Everolimus

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Everolimus

Primary Outcome Measure Information:

Title

To assess the progression-free survival (PFS) after treatment with everolimus in selected patients with metastatic melanoma (with mTOR mutation).

Time Frame

18 months

Secondary Outcome Measure Information:

Title

To assess the overall survival (OS) after treatment with everolimus in selected patients with metastatic melanoma (with mTOR mutation).

Time Frame

18 months

Title

To evaluate the safety of and tolerability to everolimus in Chinese melanoma patients.

Time Frame

18 months

Title

To evaluate the quality of life. Strategic goal: Explore and Capitalize on New Indications.

Time Frame

18 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Lu Si, MD

Phone

0086018819

Ext

6951

silu.net@hotmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Xuan Wang, MD

Phone

0086018819

Ext

6348

w_xuan_md@126.com

Facility Information:

Facility Name

LuSi

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100142

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lu Si, MD

Phone

0086018819

Ext

6951

silu.net@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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