CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 14 enrolled
Drug / intervention
RAD001 (Everolimus) and Pasireotide (SOM230) LARdrug
Likely dose
RAD001 (Everolimus) and Pasireotide (SOM230) LAR 60mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01252251
NCT01252251Phase 2Completed
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A Phase II Study of RAD001 (Everolimus) and Pasireotide (SOM230) LAR in Patients With Advanced Uveal Melanoma

Memorial Sloan Kettering Cancer Center·interventional·Posted Dec 2, 2010·Updated Aug 1, 2017

In Brief

A Phase 2 clinical trial evaluating RAD001 (Everolimus) and Pasireotide (SOM230) LAR for Uveal Melanoma. Completed, enrolled 14 participants across 1 site.

Detailed Summary

The purpose of this study is to find out what effects, good and/or bad, the drugs everolimus and pasireotide have on the patient and on melanoma. Pasireotide is also called SOM-230. Pasireotide is an experimental drug and is not approved by the Food and Drug Administration. Everolimus is also called RAD001. Everolimus is approved for use in the U.S. for kidney cancer. Everolimus is not approved for treatment of melanomas, but early studies show that it may help some patients with melanoma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUveal Melanoma
CountriesUnited States
CollaboratorsNovartis Pharmaceuticals

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedDec 2, 2010
Enrollment StartNov 1, 2010
Primary CompletionJun 1, 2016
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 15.6 years ago

Interventions

RAD001 (Everolimus) and Pasireotide (SOM230) LARdrug

Patients will be treated with SOM-230 (pasireotide) LAR 60mg IM once every 28 days and with RAD001 (Everolimus) 10mg PO daily. Each cycle is 28 days. An optional biopsy may be requested required after weeks of therapy. The biopsy may be performed between days 28 and 42.