Clinical and Translational Study of MK-0646 in Patients With Metastatic Neuroendocrine Tumors (NET)
|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: NCT00610129|
Recruitment Status : Completed
First Posted : February 7, 2008
Results First Posted : November 20, 2015
Last Update Posted : November 20, 2015
The purpose of this study is to test a new drug for neuroendocrine tumors. We think that this new drug may help control your tumor.
MK-0646 is a monoclonal antibody. An antibody is a protein that is able to attach to specific target on cancer cells. This target helps the cancer cells grow and divide. By attaching to the target, it may stop the cancer cells from further growth and dividing. This study will help find out if MK-0646 is a helpful drug when taken in patients with neuroendocrine tumor.
This study is a phase 2 study. The purpose of a phase 2 study is to find out what effects, good and/or bad, MK-0646 has on metastatic neuroendocrine tumors.
|Condition or disease||Intervention/treatment||Phase|
|Neuroendocrine Tumors Metastatic Neuroendocrine Tumors||Drug: MK-0646||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Clinical and Translational Study of MK-0646 in Patients With Metastatic Neuroendocrine Tumors (NET)|
|Study Start Date :||January 2008|
|Actual Primary Completion Date :||January 2010|
|Actual Study Completion Date :||January 2010|
MK-0646 (20 mg/mL) in sterilized solution for IV infusion (12.7 mL to deliver 12.0 mL) will be used for a dose of 10 mg/kg IV weekly administered over 60 minutes.
- Objective Response Rate (ORR) [ Time Frame: 2 years ]in patients with metastatic carcinoid tumors and in metastatic islet cell tumors (parallel cohorts) when treated with MK-0646 alone.
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): NCT00610129
|United States, New Jersey|
|Memorial Sloan-Kettering at Basking Ridge|
|Basking Ridge, New Jersey, United States, 07920|
|United States, New York|
|Memorial Sloan-Kettering Cancer Center @ Suffolk|
|Commack, New York, United States, 11725|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10065|
|Memorial Sloan-Kettering Cancer Center at Mercy Medical Center|
|Rockville Centre, New York, United States, 11570|
|Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center|
|Sleepy Hollow, New York, United States, 10591|
|Principal Investigator:||Leonard Saltz, MD||Memorial Sloan Kettering Cancer Center|