A Phase I/II, Open-label, Multicenter Study of ACY-1215 administered Orally As Monotherapy and in Combination with Bortezomib and Dexamethasone for the Treatment of Relapsed or Relapsed/Refractory Multiple Myeloma
ID Number 12-0056Principal Investigator(s)
Department(s) or Division(s)
Hematology and Medical Oncology
ACY-1215 is an experimental new drug that is being developed to see if it is safe and effective against multiple myeloma. The term "experimental" means the study drug being tested has not yet been approved by the United States Food and Drug Administration (FDA) or other regulatory agencies and is not available by prescription. ACT-1215 is thought to block enzymes that are necessary for rapidly growing cells (like cancer cells) to survive.
This study will be the first time the study drug will be studied in humans. The study has 3 parts, and you can only be in one part. At the beginning of the study, patients will be treated with a low dose of ACY-1215 alone. If this does not cause bad side effects, the dose will slowly be made higher as new patients take part in the study. In Parts 2 and 3, patients will be given ACY-1215 together with the prescription drugs bortezomib (also called Velcade) and dexamethasone.
The most important purpose of this study is to test the safety of ACY 1215. This includes trying to find out the side effects of ACY-1215 as well as trying to find out how much of the drug can be given safely to patients. In addition, the study will test the amount of drug that gets into the blood, how long it stays in the blood (pharmacokinetics or "PK"), what the drug does in the body (pharmacodynamics or "PD"), and whether ACY-1215 works against your cancer. In Part 1, ACY-1215 will be tested when given by itself. In Parts 2 and 3, ACY-1215 will be tested when given together with Velcade and dexamethasone.
Recruiting Patients: Yes