A Phase 2 interventional study of Everolimus in Melanoma, TOR Serine-Threonine Kinases and Neoplasm Metastasis, sponsored by Peking University Cancer Hospital & Institute. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-05-01.
Sponsored by Peking University Cancer Hospital & Institute · Phase 2, Interventional, and Treatment
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).
3,006 studies on the registry are indexed under Melanoma; 519 are open to participants now.
This study's planned enrollment of 60 is above the median of 38 across 2,350 interventional studies indexed under Melanoma.
Browse Melanoma studies →Peking University Cancer Hospital & Institute is the lead sponsor of 261 studies on the registry; 128 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Drug: Everolimus
To assess the progression-free survival (PFS) after treatment with everolimus in selected patients with metastatic melanoma (with mTOR mutation).
Time frame: 18 months
To assess the overall survival (OS) after treatment with everolimus in selected patients with metastatic melanoma (with mTOR mutation).
Time frame: 18 months
To evaluate the safety of and tolerability to everolimus in Chinese melanoma patients.
Time frame: 18 months
To evaluate the quality of life. Strategic goal: Explore and Capitalize on New Indications.
Time frame: 18 months
This study is status unknown, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Peking University Cancer Hospital & Institute