Study of EZN-2208 Pediatric Patients With Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
Enzon Pharmaceuticals, Inc.

Brief Summary:
The goal of this clinical research study is to find the highest tolerable dose of EZN-2208 that can be given to pediatric patients with Relapsed or Refractory Solid Tumors. The safety of the study drug and its effect on the disease will also be studied.

Condition or disease Intervention/treatment Phase
Solid Tumors Drug: EZN-2208 Phase 1 Phase 2

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : February 2010
Estimated Primary Completion Date : August 2012
Estimated Study Completion Date : August 2012

Arm Intervention/treatment
Experimental: EZN-2208
Cytotoxic Agent
Drug: EZN-2208
Other Name: PEG-SN38

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with histologic verification of malignancy at original diagnosis or relapse.
  • Measurable or evaluable disease
  • Karnofsky score more or equal to 50 for patients >16 years of age and Lansky score more or equal to 50 for patients <16 years of age
  • Patients previously treated with irinotecan will be eligible for this study if they have not had documented progressive disease during treatment with an irinotecan-containing regimen.
  • Adequate hematologic, hepatic, coagulation, renal, and metabolic function

Exclusion Criteria:

  • Pregnant or breast feeding patients will not be enrolled in this study
  • Patients who are currently receiving other anticancer agents
  • Patients who have an uncontrolled infection
  • Patients requiring cytochrome P450 3A4 enzyme inducing or inhibiting agents

Information from the National Library of Medicine

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 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
Sponsors and Collaborators
Enzon Pharmaceuticals, Inc.
Study Chair: Rochelle Bagatell, MD Developmental Therapeutics Program, The Children's Hospital of Philadelphia, CTRB 4022; 3501 Civic Center Blvd. Philadelphia, PA 19104

Responsible Party: Enzon Pharmaceuticals, Inc. Identifier: NCT01295697     History of Changes
Other Study ID Numbers: EZN-2208-05
First Posted: February 14, 2011    Key Record Dates
Last Update Posted: March 8, 2012
Last Verified: March 2012

Keywords provided by Enzon Pharmaceuticals, Inc.:
Patients with non-CNS or CNS tumors
Pediatric patients with Relapsed/Refractory Solid Tumors