Full TitleA Phase I Multiple Ascending Dose Study of DS-3032B, An Oral MDM2 Inhibitor, In Subjects with Advanced Solid Tumors or Lymphomas (Version 3.0: 29-SEP-2015)
The purpose of this study is to find the highest dose of the investigational drug DS-3032B that can be given safely in patients with advanced solid tumors and lymphomas that are not responding well to standard treatments or for which no standard treatment exists. DS-3032B works against cancer by blocking the activity of a protein called MDM2.
Normal MDM2 helps cells to grow and then die, but when MDM2 is damaged, cancer cells can grow continuously. DS-3032B targets cancer cells with damaged MDM2. It can only work when a patient’s tumor also has normal, functioning p53 (a protein which puts the brakes on rampant cell growth), so patients’ tumors must contain normal p53 for DS-3032B to work.
DS-3032B is taken orally (by mouth).
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have an advanced solid tumor or lymphoma that is not responding well to standard treatment or for which no standard treatment exists.
- Patients with tumors that have known mutations in the p53 gene may not participate.
- At least 3 weeks must have passed since completion of prior anticancer therapy (4 weeks since radiation therapy or major surgery) and entry into the study.
- Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
- This study is open to patients age 18 and older.
For more information about this study and to inquire about eligibility, please contact the Developmental Therapeutics Clinic (DTC) at 646-888-4226.