A Phase 1/2 Study of EZN-2208 in Children, Adolescents, and Young Adults With Relapsed or Refractory Solid Tumors
Pharmacokinetic (PK) testing of EZN-2208, will be performed for patients who volunteer. PK
testing measures the amount of a drug in the body at different time points.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine the MTD and recommended phase 2 dose of i.v. EZN-2208 administered q3wk.
The study will measure incidence, severity and duration of adverse events graded by NCI CTCAE during first cycle of therapy to determine the MTD. A Phase 2 Dose will be recommended by study investigators after considering the frequency and severity of adverse events and the ability to maintain dose schedule
Rochelle Bagatell, MD
Developmental Therapeutics Program, The Children's Hospital of Philadelphia, CTRB 4022; 3501 Civic Center Blvd. Philadelphia, PA 19104
United States: Food and Drug Administration
|Lia Gore, MD||Aurora, Colorado 80045|
|Suzanne Shusterman, MD||Boston, Massachusetts 02115|
|Rochelle Bagatell, MD (Principal Investigator)||Philadelphia, Pennsylvania 19104|
|Jodi Muscal, MD||Houston, Texas 77030|