Study of MK-2206 in Patients With Metastatic Neuroendocrine Tumors (NET)
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Clinical and Translational Study of MK-2206 in Patients With Metastatic Neuroendocrine Tumors (NET)|
- Overall Response. [ Time Frame: every 12 weeks ] [ Designated as safety issue: No ]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.
|Study Start Date:||July 2010|
|Study Completion Date:||February 2014|
|Primary Completion Date:||February 2014 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|