Clinical And Translational Study Of MK-2206 In Patients With Metastatic KRAS-Wild-Type, PIK3CA-Mutated, Colorectal Cancer
|ClinicalTrials.gov Identifier: NCT01186705|
Recruitment Status : Terminated (Lack of accrual)
First Posted : August 23, 2010
Results First Posted : April 21, 2015
Last Update Posted : November 18, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Colon Cancer Rectal Cancer||Drug: MK-2206||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 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 KRAS-Wild-Type, PIK3CA-Mutated, Colorectal Cancer|
|Study Start Date :||August 2010|
|Actual Primary Completion Date :||August 2011|
|Actual Study Completion Date :||August 2011|
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.
- Overall Objective Response Rate (ORR) [ Time Frame: 1 year ]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)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|