A Phase 1/1b Study of MGCD516 in Patients With Advanced Solid Tumor Malignancies
This is a phase 1/1b research study for adults with a diagnosis of an advanced solid tumor for which there are no standard therapies beyond those that may have already been received. This study involves an investigational (experimental) drug called MGCD516. Investigational means that MGCD516 is not approved by the U.S. Food and Drug Administration (FDA). 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. Studies in animals with tumors have shown that MGCD516 is able to shrink or slow down the growth of tumors. This clinical trial will be the first time that MGCD516 will be administered to humans. 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.
Are you Eligible? (Inclusion Criteria)
1. Histologically confirmed diagnosis of an advanced solid tumor malignancy.
2. Unresectable or metastatic disease for which standard treatment is not available.
3. Age >=18 years.
4. Most recent prior therapy (e.g., chemotherapy, radiation therapy, or investigational agent) discontinued at least 3 weeks before first dose date.
5. Recovery from the adverse effects of prior therapy at the time of enrollment to <= Grade 1 (excluding alopecia).