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

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01960829

Enrollment

Registered

2013-10-11

Start date

2013-09-30

Completion date

Unknown

Last updated

2015-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melanoma, Neoplasm Metastasis, TOR Serine-Threonine Kinases

Keywords

melanoma, TOR Serine-Threonine Kinases

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).

Interventions

DRUGEverolimus

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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.

Design outcomes

Primary

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

Secondary

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

Countries

China

Contacts

Primary ContactLu Si, MD

silu.net@hotmail.com0086018819

Backup ContactXuan Wang, MD

w_xuan_md@126.com0086018819

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026