Study of EZN-2208 Pediatric Patients With Solid Tumors
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|ClinicalTrials.gov Identifier: NCT01295697|
Recruitment Status : Unknown
Verified March 2012 by Enzon Pharmaceuticals, Inc..
Recruitment status was: Active, not recruiting
First Posted : February 14, 2011
Last Update Posted : March 8, 2012
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumors||Drug: EZN-2208||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1/2 Study of EZN-2208 in Children, Adolescents, and Young Adults With Relapsed or Refractory Solid Tumors|
|Study Start Date :||February 2010|
|Estimated Primary Completion Date :||August 2012|
|Estimated Study Completion Date :||August 2012|
Other Name: PEG-SN38
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|