MK-2206 and AZD6244 in Patients With Advanced Colorectal Carcinoma

Completed · Phase 2

Conditions studied: Colorectal Neoplasms

In brief

Background: \- MK-2206 and AZD6244 (Selumetinib) are experimental cancer treatment drugs that block the effect of certain proteins that cancer cells need to grow and survive. These drugs may be effective treatments for some types of colorectal cancer that has not responded to or has relapsed after standard treatment. Researchers are interested in studying how MK-2206 and AZD6244 affect levels of certain proteins in colorectal cancer tumor, and how well the drugs work against cancer cells by examining cells from a tumor sample collected before the drugs are given and again after the drugs are given. Objectives: \- To evaluate the safety and effectiveness of MK-2206 and AZD6244 in individuals with advanced colorectal carcinoma that has not responded to standard treatments. Eligibility: \- Individuals at least 18 years of age who have been diagnosed with advanced colorectal carcinoma that has not responded to at least one type of standard chemotherapy. Design: * Participants will be screened with a physical examination, medical history, blood tests, and tumor imaging studies. * Participants will take MK-2206 and AZD6244 by mouth for 4-week cycles of treatment, with one dose of MK-2206 per week and one dose of AZD6244 every day. (If participants have negative side effects from the medications, the doses will be adjusted to a smaller dose). Participants will keep a diary to record doses and keep track of any side effects. * During treatment, participants will have regular visits to the clinical center, involving blood and urine tests, tumor biopsies, and other examinations to monitor the effects of treatment. Participants will have imaging studies every two cycles (8 weeks) to study the cancer's response to the treatment. * Participants will continue to have cycles of treatment for as long as the treatment continues to be effective and the side effects are not severe enough to stop participation in the study....

Key facts

Study ID: NCT01333475
Run by: National Cancer Institute (NCI)
People needed: 21
Starts: 2011-03-01
Expected to finish: 2014-09-01
Last updated by the study team: 2015-09-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

Patients who are receiving any other investigational agents.
Patients with known brain metastases or carcinomatous meningitis are excluded from this clinical trial, with the exception of patients whose brain metastatic disease status has remained stable for greater than or equal to 4 weeks after treatment of the brain metastases, without steroids. Patients on stable doses of antiseizure medications with no history of seizures in the past 4 weeks will be eligible.
Poorly controlled diabetes defined as fasting blood glucose of greater than 160 mg/dL (CTCAE (Common Terminology Criteria for Adverse Events)) Grade greater than or equal to 2) or HgA1c (glycated hemoglobin) greater than 8%.
QTc (corrected QT interval) prolongation greater than 450 msec (male) or QTc greater than 470 msec (female) by Bazetts formula or use of medications that may cause QTc interval prolongation. A comprehensive list of agents with the potential to cause QTc prolongation can be found at http://www.azcert.org/medical-pros/drug- lists/bycategory.cfm.
Patients with clinically significant intercurrent illnesses, including but not limited to, interstitial pneumonitis, pulmonary fibrosis, uncontrolled infection, psychiatric illness or social situations that would limit compliance with study requirements.
Patients with symptomatic congestive heart failure, unstable angina, uncontrolled cardiac arrhythmia, myocardial infarction in the past 6 months, left ventricular ejection fraction (LVEF) less than or equal to 50%, are not eligible to participate.
Uncontrolled hypertension (blood pressure [BP] of greater than or equal to 150/95 despite optimal therapy).
Refractory nausea and vomiting, chronic gastrointestinal diseases (e.g., inflammatory bowel disease), or significant bowel resection that would preclude adequate absorption.
HIV (human immunodeficiency virus) -positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with MK-2206 and AZD6244.
Patients currently on warfarin (Coumadin) are ineligible. Otherwise eligible patients requiring anticoagulant treatment should have their warfarin switched to a low molecular weight heparin such as enoxaparin injections.
Patients on strong cytochrome P450 system inducers or inhibitors are ineligible.
INCLUSION OF WOMEN AND MINORITIES:
Both men and women of all races and ethnic groups are eligible for this trial.

Where it is running

National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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