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

NCT ID: NCT01960829

Last Updated: 2015-05-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30

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).

Conditions

Melanoma; TOR Serine-Threonine Kinases; Neoplasm Metastasis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Everolimus

Group Type: EXPERIMENTAL

Everolimus

Intervention Type: DRUG

Interventions

Everolimus

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University Cancer Hospital & Institute

OTHER

Sponsor Role: lead

Responsible Party

Lu Si

Beijing Cancer Hospital Department of Renal Cancer and Melanoma

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

LuSi

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Lu Si, MD

Role: CONTACT

silu.net@hotmail.com

0086018819 ext. 6951

Xuan Wang, MD

Role: CONTACT

w_xuan_md@126.com

0086018819 ext. 6348

Facility Contacts

Lu Si, MD

Role: primary

silu.net@hotmail.com

0086018819 ext. 6951

Other Identifiers

CRAD001CCN28T

Identifier Type: -

Identifier Source: org_study_id