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

December 3, 2010
March 7, 2012
February 2010
August 2012   (final data collection date for primary outcome measure)
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

Same as current
Complete list of historical versions of study NCT01295697 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Study of EZN-2208 Pediatric Patients With Solid Tumors
A Phase 1/2 Study of EZN-2208 in Children, Adolescents, and Young Adults With Relapsed or Refractory Solid Tumors

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.

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.

Interventional
Phase 1
Phase 2
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Solid Tumors
Drug: EZN-2208
Experimental
Other Name: PEG-SN38
Experimental: EZN-2208
Cytotoxic Agent
Intervention: Drug: EZN-2208
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
24
August 2012
August 2012   (final data collection date for primary outcome measure)

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
Both
1 Year to 21 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01295697
EZN-2208-05
No
Enzon Pharmaceuticals, Inc.
Enzon Pharmaceuticals, Inc.
Not Provided
Study Chair: Rochelle Bagatell, MD Developmental Therapeutics Program, The Children's Hospital of Philadelphia, CTRB 4022; 3501 Civic Center Blvd. Philadelphia, PA 19104
Enzon Pharmaceuticals, Inc.
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP