A Phase II Study of RAD001 (Everolimus) and Pasireotide (SOM230)) in Patients with Advanced Uveal Melanoma

Protocol
10-123
Full Title
A Phase II Study of RAD001 (Everolimus) and Pasireotide (SOM230) LAR in Patients with Advanced Uveal Melanoma
Phase
II
Purpose

Uveal melanoma is difficult to treat successfully. Pasireotide (SOM230) is an investigational targeted therapy that binds to proteins called somatostatin receptors. Everolimus is an oral drug that inhibits a molecule called mTOR, which helps cancer cells grow. Everolimus is approved for the treatment of renal cell carcinoma, but its use for treating uveal melanoma is considered investigational.

Researchers believe that both somatostatin receptors and mTOR are important for the growth of uveal melanoma. They hope that by blocking both proteins, they can prevent tumor growth or cause tumors to shrink. The purpose of this study is to evaluate the safety and effectiveness of combining pasireotide and everolimus in patients with uveal melanoma that has spread or has not responded to treatment.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have metastatic uveal melanoma
  • Patients may not have received prior somatostatin analogue or mTOR inhibitor therapy.
  • At least 3 weeks must have passed since completion of prior chemotherapy and entry into the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • Patients must be age 18 or older.

For more information about this study and to inquire about eligibility, please contact Dr. Richard D. Carvajal at 646-888-4164.

Disease(s)
Melanoma: Melanoma of the Eye
Locations
Related Diseases