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Study Title: Phase I, oral agent for Advanced Cancers
Category: Cancer, General

Currently accepting participants?
Not at this time.

Principal Investigator: Vincent Picozzi
Study Coordinator: Andrea Jacks
Phone: (206) 625-7373 Ext.63979
Email: andrea.jacks@vmmc.org

What is the Phase I, oral agent for Advanced Cancers study?

This trial is multicenter, open-label, and non-randomized. Patients will be administered MK2461, a cMet inhibitor, orally twice a day as a 28 day cycle. Dose escalation will continue until the maximum tolerated dose (MTD) is determined.

Who can participate?

SUBJECT/PATIENT INCLUSION CRITERIA
? Patient’s malignancy must demonstrate phospho-cMet positivity
? Patient is willing to undergo pre-study and post dose tumor biopsy and have tumor accessible to biopsy
? Patient has a histologically-confirmed metastatic or locally advanced solid tumor that has failed to respond to standard therapy, progressed despite standard therapy, or for which standard therapy does not exist. There is no limit on the number of prior treatment regimens.
? Patient has performance status 0 or 1 on the ECOG Performance Scale
? Patient has adequate organ function
SUBJECT/PATIENT EXCLUSION CRITERIA
A patient meeting any of the following criteria is not eligible to participate in this study:
? Patient who has had chemotherapy, radiotherapy, or biological therapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study. If the patient has residual toxicity from prior chemotherapy treatment, toxicity must be ? Grade 1.
? Patient with a primary central nervous system tumor
? Patient has known hypersensitivity to the components of study drug or its analogs
? Patient has had prescription or non-prescription drugs or other products known to be metabolized by CYP3A4

What do I have to do as a study participant?

Patient must be willing to return to the clinic for several blood draws during the first 30 days of dosing with study drug.

Study Summary:

Phase I trial for patients with metastatic or locally advanced solid tumors that have failed to respond to standard therapy, progressed despite standard therapy, or for which standard therapy does not exist.

Detailed Study Description:

(No information)

Study Design: Interventional
Phase of Study: Phase I
Study Type: Interventional
Condition or Study Focus: Advanced Cancer
Intervention Type: Drug
Intervention Name: MK-2461
Gender: Male and Female
Age group: Interventional
Sponsor: Merck


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