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Protocol No. UW15054

Principal Investigator Kyriakopoulos, Christos

Phase I

Age Group Adult

Scope National

Sponsor Type Industry

Title A Phase 1/1b Study of MGCD516 in Patients with Advanced Solid Tumor Malignancies

Objective The main purposes of this study are to identify how much MGCD516 can safely be administered to patients, how much drug is absorbed after taking MGCD516 capsules orally and how quickly the drug is cleared from the blood stream. Other things that will be studied include the effects of MGCD516 on your cancer and whether patients with very specific kinds of cancer should be included in future clinical trials.

Treatment This is a study involving an investigational (experimental) drug called MGCD516 being developed by Mirati Therapeutics Inc. (which is the company that provides MGCD516 and is supporting the study). Investigational means that MGCD516 is not approved by the U.S. Food and Drug Administration (FDA). MGCD516 is an experimental drug that belongs to a class of drugs known as tyrosine kinase inhibitors. MGCD516 is being developed as a possible treatment for different types of cancer. MGCD516 is 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.

Description This study will be the first-in-human study for MGCD516. In this study, MGCD516 will be taken as capsules by mouth. In the Phase 1b part of the study, groups of patients with very specific kinds of cancer receive a regimen of MGCD516 at the highest dose that is considered tolerable to most patients. Before you can receive the study drug MGCD516, you will have what are called "screening tests" to help the study doctor decide if you are eligible to take part in this study. These tests will last about 9-10 hours total, but may be spread over two days.If you are found to be eligible to take part in this study, and you decide to participate, the dose of MGCD516 that you will receive will be based on the safety data that are available at that time, and on the experience with taking MGCD516 of the participants who have been enrolled before you.Click here for more info

Key Eligibility
  • Confirmed diagnosis of an advanced solid tumor malignancy
  • Unresectable or metastatic disease for which standard treatment is not available
  • Prior history of cancer is allowed, as long as there is no suspected active disease
  • Patients with symptomatic or uncontrolled brain metastases are not eligible

Applicable Disease Sites Anal; Bladder; Brain/Central Nervous System; Breast; Cervix; Colon and Rectum; Endocrine cancers; Esophagus; Gastrointestinal cancers, other; Genitourinary cancers, other; Head and Neck; Kidney; Liver; Lung; Ovary; Pancreas; Prostate; Sarcoma; Stomach; Testicular; Thyroid; Uterus; Vagina; Vulva

Therapies Involved Cytotoxic Chemotherapy

Drugs Involved MGCD516

Status Open

Participating Institutions UW Hospital and Clinics