Study of MK-2206 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: NCT01169649|
Recruitment Status : Completed
First Posted : July 26, 2010
Results First Posted : February 18, 2016
Last Update Posted : February 18, 2016
The purpose of this study is to test a new drug called MK-2206. This study is a phase II study. In cancer studies, a phase II study is to find out what effects, good and/or bad, a new treatment has against a certain type of cancer.
MK-2206 is an oral medication known as a targeted therapy. By attaching to the target, we hope that MK-2206 may stop the cancer cells from further growth and dividing. This study will help find out if MK-2206 is a helpful drug when taken in patients with neuroendocrine tumor.
|Condition or disease||Intervention/treatment||Phase|
|PANCREAS Neuroendocrine||Drug: MK-2206||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Clinical and Translational Study of MK-2206 in Patients With Metastatic Neuroendocrine Tumors (NET)|
|Study Start Date :||July 2010|
|Actual Primary Completion Date :||February 2014|
|Actual Study Completion Date :||February 2014|
Experimental: islet cell carcinomas and carcinoid tumors
This is an open label phase II study of MK-2206 administered to patients with metastatic neuroendocrine tumors.
MK-2206 will be given orally 200 mg qw as given in the prior Ph1 clinical trial that demonstrated safety, tolerability and adequate PK/PD values at this dose. Follow-up imaging scans will be performed every 12 weeks to evaluate response. Patients must take MK-2206 orally at least 2 hours before or 2 hours after food or a meal.
- Overall Response. [ Time Frame: every 12 weeks ]Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
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): NCT01169649
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Diane Reidy-Lagunes, MD,MS||Memorial Sloan Kettering Cancer Center|