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

Melanoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01960829
• Other study ID #: CRAD001CCN28T
• Status: Recruiting
• Phase: Phase 2
• First received: September 24, 2013
• Last updated: April 30, 2015
• Start date: September 2013

Study information

• Verified date: April 2015
• Source: Beijing Cancer Hospital
• Contact: Lu Si, MD
• Phone: 0086018819
• Email: silu.net[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma
• Neoplasm Metastasis
• TOR Serine-Threonine Kinases

Intervention

Drug:
• Everolimus

Locations

Country	Name	City	State
China	LuSi	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the progression-free survival (PFS) after treatment with everolimus in selected patients with metastatic melanoma (with mTOR mutation).		18 months	Yes
Secondary	To assess the overall survival (OS) after treatment with everolimus in selected patients with metastatic melanoma (with mTOR mutation).		18 months	Yes
Secondary	To evaluate the safety of and tolerability to everolimus in Chinese melanoma patients.		18 months	Yes
Secondary	To evaluate the quality of life. Strategic goal: Explore and Capitalize on New Indications.		18 months	Yes