Study of EZN-2208 Pediatric Patients With Solid Tumors

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Enzon Pharmaceuticals, Inc..
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Enzon Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01295697
First received: December 3, 2010
Last updated: March 7, 2012
Last verified: March 2012
  Purpose

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 Intervention Phase
Solid Tumors
Drug: EZN-2208
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
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

Resource links provided by NLM:


Further study details as provided by Enzon Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Determine the MTD and recommended phase 2 dose of i.v. EZN-2208 administered q3wk. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

    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:
  • Assess evidence of tumor response activity of EZN-2208 [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    The pharmacokinetics of EZN-2208 will be established by measuring the concentration of EZN-2208 and SN-38 over time in patient blood samples.


Estimated Enrollment: 24
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)
Arms Assigned Interventions
Experimental: EZN-2208
Cytotoxic Agent
Drug: EZN-2208
Experimental
Other Name: PEG-SN38

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.

  Eligibility

Ages Eligible for Study:   1 Year to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01295697

Locations
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.
Investigators
Study Chair: Rochelle Bagatell, MD Developmental Therapeutics Program, The Children's Hospital of Philadelphia, CTRB 4022; 3501 Civic Center Blvd. Philadelphia, PA 19104
  More Information

No publications provided

Responsible Party: Enzon Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01295697     History of Changes
Other Study ID Numbers: EZN-2208-05
Study First Received: December 3, 2010
Last Updated: March 7, 2012
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on October 21, 2014