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Clinical And Translational Study Of MK-2206 In Patients With Metastatic KRAS-Wild-Type, PIK3CA-Mutated, Colorectal Cancer | Clinical Trials | Clareo Health

TERMINATEDPHASE2

Clinical And Translational Study Of MK-2206 In Patients With Metastatic KRAS-Wild-Type, PIK3CA-Mutated, Colorectal Cancer

A Phase II Clinical And Translational Study Of MK-2206 In Patients With Metastatic KRAS-Wild-Type, PIK3CA-Mutated, Colorectal Cancer

NCT01186705•Memorial Sloan Kettering Cancer Center

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patient must have metastatic colorectal cancer that has been histologically or cytologically-confirmed at MSKCC and has failed to respond to appropriate standard therapy regimens. There is no limit on the number of prior treatment regimens permitted.
•Patient is male or female and ≥18 years of age on the day of signing informed consent.
•Patient must have performance status of 0 or 1 on the ECOG Performance Scale.
•Patient must have adequate organ function as indicated by the following laboratory values:
•Absolute neutrophil count (ANC) ≥1,500 /μL
•Platelets ≥100,000 /μL
•Hemoglobin ≥9 g/dL
•Serum creatinine or calculated creatinine clearance ≤1.5 x upper limit of normal (ULN) OR ≥60 mL/min for patients with creatinine levels \>1.5 x institutional ULN
•Serum total bilirubin ≤1.5 x ULN OR direct bilirubin ≤ ULN for patients with total bilirubin levels \>1.5 x ULN
•AST (SGOT) and ALT (SGPT) ≤3 x ULN or ≤5 x ULN in patients with known liver metastasis
+9 more criteria

Exclusion Criteria

•Patient who has had chemotherapy, radiotherapy, or biological therapy within 3 weeks (6 weeks for nitrosoureas or mitomycin C), or who has not recovered from the adverse events due to previous agents administered more than 4 weeks prior to Study Day 1. If the patient has residual toxicity from prior treatment, toxicity must be ≤ Grade 1.
•Patients must be at least 4 weeks post major surgical procedure, and all surgical wounds must be fully healed.
•Patient is currently participating or has participated in a study with an investigational compound or device within 30 days of Study Day 1.
•Patient has known CNS metastases and/or carcinomatous meningitis.
•Patient has a primary central nervous system tumor.
•Patient has known hypersensitivity to the components of study drug or its analogs.
•Patient has a history or current evidence of clinically significant heart disease including:
•Clinically significant congestive heart failure, unstable angina pectoris,
•Clinically significant cardiac arrhythmia,
•History or current evidence of a myocardial infarction during the last 6 months, and/or a current ECG tracing that is abnormal in the opinion of the treating Investigator,
+12 more criteria

Locations (1)

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Key Dates

Start Date

August 1, 2010

Primary Completion Date

August 1, 2011

Completion Date

August 1, 2011

Last Updated

November 18, 2015

Enrollment

ACTUAL participants

Conditions

Colon CancerRectal Cancer

Interventions

MK-2206

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 18, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Clinical And Translational Study Of MK-2206 In Patients With Metastatic KRAS-Wild-Type, PIK3CA-Mutated, Colorectal Cancer

Inclusion Criteria

Exclusion Criteria

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

Clinical Trial of an Anti-cancer Drug, CA-4948 (Emavusertib), in Combination With Chemotherapy Treatment (FOLFOX Plus Bevacizumab) in Metastatic Colorectal Cancer

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