RAD001 (Everolimus) and Pasireotide (SOM230) LAR in Patients With Advanced Uveal Melanoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01252251|
Recruitment Status : Completed
First Posted : December 2, 2010
Results First Posted : August 1, 2017
Last Update Posted : August 1, 2017
|Condition or disease||Intervention/treatment||Phase|
|Uveal Melanoma||Drug: RAD001 (Everolimus) and Pasireotide (SOM230) LAR||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of RAD001 (Everolimus) and Pasireotide (SOM230) LAR in Patients With Advanced Uveal Melanoma|
|Study Start Date :||November 2010|
|Actual Primary Completion Date :||June 2016|
|Actual Study Completion Date :||June 2016|
Experimental: RAD001 and pasireotide LAR
This study will be an open-label, single-arm, phase II study of RAD001 and pasireotide LAR.
Drug: RAD001 (Everolimus) and Pasireotide (SOM230) LAR
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.
- Number of Participants With Complete Response (CR) [ Time Frame: at 16 weeks ]For patients with metastatic uveal melanoma treated with RAD001 and pasireotide LAR.
- Number of Participants With Partial Response (PR) [ Time Frame: at 16 weeks ]For patients with metastatic uveal melanoma treated with RAD001 and pasireotide LAR.
- Number of Participants With Stable Disease (SD) [ Time Frame: at 16 weeks ]For patients with metastatic uveal melanoma treated with RAD001 and pasireotide LAR.
- Median Progression Free Survival(PFS) [ Time Frame: Up to 3 years ]
- Safety and Toxicity in This Patient Population. [ Time Frame: 16 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,
- Median Overall Survival (OS) [ Time Frame: Up to 3 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01252251
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Michael Postow, MD||Memorial Sloan Kettering Cancer Center|