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

Phase 2

• Conditions: Neoplasm Metastasis; Melanoma; TOR Serine-Threonine Kinases
• Interventions: Drug: Everolimus

• Registration Number: NCT01960829
• Lead Sponsor: Peking University Cancer Hospital & Institute

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-09-24
• Study First Submitted QC: 2013-10-09
• Study First Posted: 2013-10-11
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-30
• Primary Completion: 2015-05
• Last Update Posted: 2015-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Everolimus	Everolimus	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

LuSi; 🇨🇳 Beijing, Beijing, China