Clinical Trial: RAD001 (Everolimus) and Pasireotide (SOM230) LAR in Patients With Advanced Uveal Melanoma

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase II Study of RAD001 (Everolimus) and Pasireotide (SOM230) LAR in Patients With Advanced Uveal Melanoma

Brief 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.

Detailed Summary:
Sponsor: Memorial Sloan Kettering Cancer Center

Current Primary Outcome:

• To determine the clinical benefit rate as defined as complete response (CR) [ Time Frame: at 16 weeks ]
  For patients with metastatic uveal melanoma treated with RAD001 and pasireotide LAR.
• To determine the clinical benefit rate as defined as partial response (PR) [ Time Frame: at 16 weeks ]
  For patients with metastatic uveal melanoma treated with RAD001 and pasireotide LAR.
• To determine the clinical benefit rate as defined as or stable disease (SD) [ Time Frame: at 16 weeks ]
  For patients with metastatic uveal melanoma treated with RAD001 and pasireotide LAR.

Original Primary Outcome: Same as current

Current Secondary Outcome:

• To determine the median progression free survival(PFS)and overall survival (OS). [ Time Frame: 3 years ]
• To further evaluate safety and toxicity in this patient population. [ Time Frame: every 2 weeks ]
  Safety assessments will consist of monitoring and recording all adverse events, including serious adverse events, the regular monitoring of hematology (including glycosylated hemoglobin and coagulation parameters), blood chemistry (including fasting glucose, thyroid function tests, GH, IGF-1 and prolactin), urinalysis, regular monitoring of vital signs, echocardiography, ECGs, and body weight. Toxicity will be assessed using the NCI-CTC for Adverse Events, version 4.0 (CTCAEv4.0,

Original Secondary Outcome: Same as current

Information By: Memorial Sloan Kettering Cancer Center

Dates:
Date Received: December 1, 2010
Date Started: November 2010
Date Completion:
Last Updated: June 16, 2016
Last Verified: June 2016