Study of EZN-2208 Pediatric Patients With Solid Tumors
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 1/2 Study of EZN-2208 in Children, Adolescents, and Young Adults With Relapsed or Refractory Solid Tumors|
- Determine the MTD and recommended phase 2 dose of i.v. EZN-2208 administered q3wk. [ Time Frame: 2 years ]
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
- Assess evidence of tumor response activity of EZN-2208 [ Time Frame: 2 years ]An evaluation of objective Tumor response by radiographic scans will be performed every two cycles following the criteria of RECIST 1.1.
- Evaluate the safety and tolerability of EZN-2208 [ Time Frame: 2 years ]The incidence, severity and duration of adverse events graded by NCI CTCAE during all cycles of therapy will be used to assess safety and tolerability.
- Assess the PK profile of EZN-2208 [ Time Frame: 2 years ]The pharmacokinetics of EZN-2208 will be established by measuring the concentration of EZN-2208 and SN-38 over time in patient blood samples.
|Study Start Date:||February 2010|
|Estimated Study Completion Date:||August 2012|
|Estimated Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
Other Name: PEG-SN38
Please refer to this study by its ClinicalTrials.gov identifier: NCT01295697
|United States, Colorado|
|Lia Gore, MD|
|Aurora, Colorado, United States, 80045|
|United States, Massachusetts|
|Suzanne Shusterman, MD|
|Boston, Massachusetts, United States, 02115|
|United States, Pennsylvania|
|Rochelle Bagatell, MD (Principal Investigator)|
|Philadelphia, Pennsylvania, United States, 19104|
|United States, Texas|
|Jodi Muscal, MD|
|Houston, Texas, United States, 77030|
|Study Chair:||Rochelle Bagatell, MD||Developmental Therapeutics Program, The Children's Hospital of Philadelphia, CTRB 4022; 3501 Civic Center Blvd. Philadelphia, PA 19104|