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

P

Peking University Cancer Hospital & Institute

Status and phase

Unknown
Phase 2

Conditions

Melanoma
TOR Serine-Threonine Kinases
Neoplasm Metastasis

Treatments

Drug: Everolimus

Study type

Interventional

Funder types

Other

Identifiers

NCT01960829
CRAD001CCN28T

Details and patient eligibility

About

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).

Enrollment

60 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

60 participants in 1 patient group

Everolimus
Experimental group
Treatment:
Drug: Everolimus

Trial contacts and locations

1

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Central trial contact

Xuan Wang, MD; Lu Si, MD

Data sourced from clinicaltrials.gov

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