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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01252251
First Posted: December 2, 2010
Last Update Posted: August 1, 2017
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.
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
Results First Submitted: May 15, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Uveal Melanoma
Intervention: Drug: RAD001 (Everolimus) and Pasireotide (SOM230) LAR

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Protocol Open to Accrual 11/30/2010, Protocol Closed to Accrual 8/11/2015, Primary Completion Date 6/13/2016, Recruitment location is the medical clinic

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
RAD001 and Pasireotide LAR

This study will be an open-label, single-arm, phase II study of RAD001 and pasireotide LAR.

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.


Participant Flow:   Overall Study
    RAD001 and Pasireotide LAR
STARTED   14 
COMPLETED   13 
NOT COMPLETED   1 
Withdrawal by Subject                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
RAD001 and Pasireotide LAR

This study will be an open-label, single-arm, phase II study of RAD001 and pasireotide LAR.

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.


Baseline Measures
   RAD001 and Pasireotide LAR 
Overall Participants Analyzed 
[Units: Participants]
 14 
Age 
[Units: Years]
Median (Full Range)
 61 
 (41 to 83) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      8  57.1% 
Male      6  42.9% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      13  92.9% 
Not Hispanic or Latino      0   0.0% 
Unknown or Not Reported      1   7.1% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      0   0.0% 
White      13  92.9% 
More than one race      0   0.0% 
Unknown or Not Reported      1   7.1% 
Region of Enrollment 
[Units: Participants]
Count of Participants
 
United States   14 


  Outcome Measures
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1.  Primary:   Number of Participants With Complete Response (CR)   [ Time Frame: at 16 weeks ]

2.  Primary:   Number of Participants With Partial Response (PR)   [ Time Frame: at 16 weeks ]

3.  Primary:   Number of Participants With Stable Disease (SD)   [ Time Frame: at 16 weeks ]

4.  Secondary:   Median Progression Free Survival(PFS)   [ Time Frame: Up to 3 years ]

5.  Secondary:   Safety and Toxicity in This Patient Population.   [ Time Frame: 16 weeks ]

6.  Secondary:   Median Overall Survival (OS)   [ Time Frame: Up to 3 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Michael Postow, MD
Organization: Memorial Sloan Kettering Cancer Center
phone: 646-888-4589
e-mail: PostowM@mskcc.org



Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01252251     History of Changes
Other Study ID Numbers: 10-123
First Submitted: December 1, 2010
First Posted: December 2, 2010
Results First Submitted: May 15, 2017
Results First Posted: August 1, 2017
Last Update Posted: August 1, 2017