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Treatment Study for Patients with Advanced Solid Tumor Malignancies

Clinical Trial Title: 
Phase 1/1b study of MGCD516 in patients with advanced solid tumor malignancies.
Clinical Trial Protocol ID: 
16071502
Clinical Trial Investigator Name: 
Marta Batus, MD
Clinical Trial Protocol Description: 

This is a study involving an investigational (experimental) drug called MGCD516 that is being developed by Mirati Therapeutics, Inc. MGCD516 is a receptor tyrosine kinase (RTK) inhibitor designed to block specific tyrosine kinases, which are proteins that are thought to cause tumors to grow. MGCD516 is also designed to slow down the growth of new blood vessels that help tumors to grow and spread. Studies in animals with tumors have shown that MGCD516 is able to shrink or slow down the growth of tumors. It is not yet known whether MGCD516 will do the same in patients, where the growth of tumors is more complicated. This clinical trial will be the first time that MGCD516 will be administered to people.

In this study, MGCD516 is orally administered to patients with advanced solid tumor malignancies to evaluate its safety, pharmacokinetic, metabolism, pharmacodynamic and clinical activity profiles.

During the Phase 1 segment the dose and regimen of MGCD516 will be assessed and during the Phase 1b segment the clinical activity of MGCD516 will be evaluated in selected patient populations.

Clinical Trial Eligibility Criteria: 

In order to participate you must meet the following criteria:

  • Have an advanced (metastatic or unresectable) solid tumor for which there are no standard therapies beyond those which you may have already received.
  • Have adequate bone marrow and organ function.
  • Are 18 years old or older.

This is a partial list of elgibility requirements.

Clinical Trial Area: 
Lung and Chest Tumors
Contact Phone: 
(312) 563-3347
Contact Name: 
Deborah Pach, RN