Clinical And Translational Study Of MK-2206 In Patients With Metastatic KRAS-Wild-Type, PIK3CA-Mutated, Colorectal Cancer
The purpose of this study is to test a new drug called MK-2206 for metastatic colorectal cancer. This drug is being tested in a subgroup of patients with colorectal cancer whose tumors have changes in certain genes that may make them more likely to respond to this new medication. As tumors develop, the cells within the tumor acquire mutations within genes, allowing them to grow more effectively. We will be testing your tumor for mutations involving two genes - KRAS and PIK3CA. Patients whose tumors have a normal copy of the KRAS gene and a mutation within the PIK3CA gene will be eligible to participate in this study.
This study is a phase 2 study. The goal of a phase 2 study is to find out what effects, good and/or bad, a new treatment has against a certain type of cancer.
|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 KRAS-Wild-Type, PIK3CA-Mutated, Colorectal Cancer|
- Overall Objective Response Rate (ORR) [ Time Frame: 1 year ] [ Designated as safety issue: No ]in patients with metastatic colorectal cancer with known PIK3CA mutations and wild type KRAS, to single agent MK-2206. Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1)
|Study Start Date:||August 2010|
|Study Completion Date:||August 2011|
|Primary Completion Date:||August 2011 (Final data collection date for primary outcome measure)|
This will be a single-arm, phase II study of the AKT inhibitor MK-2206 in patients with KRAS-wild-type, PIK3CA-mutated, colorectal cancer whose tumors have progressed through standard chemotherapy regimens.
Patients will receive MK-2206 orally in a once weekly dose of 200mg. There will be no dose escalation. Patients will be treated until disease progression or unacceptable side effects.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01186705
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Leonard Saltz, MD||Memorial Sloan Kettering Cancer Center|