Study of EZN-2208 Pediatric Patients With Solid Tumors

Solid Tumors Clinical Trial

Official title:

A Phase 1/2 Study of EZN-2208 in Children, Adolescents, and Young Adults With Relapsed or Refractory Solid Tumors

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01295697
• Other study ID #: EZN-2208-05
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: February 2010
• Est. completion date: January 2013

Study information

• Verified date: March 2012
• Source: Enzon Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 32
• Est. completion date: January 2013
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumors

Intervention

Drug:
• EZN-2208
Experimental

Locations

Country	Name	City	State
United States	Lia Gore, MD	Aurora	Colorado
United States	Suzanne Shusterman, MD	Boston	Massachusetts
United States	Jodi Muscal, MD	Houston	Texas
United States	Rochelle Bagatell, MD (Principal Investigator)	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Enzon Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the MTD and recommended phase 2 dose of i.v. EZN-2208 administered q3wk.	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	2 years
Secondary	Assess evidence of tumor response activity of EZN-2208	An evaluation of objective Tumor response by radiographic scans will be performed every two cycles following the criteria of RECIST 1.1.	2 years
Secondary	Evaluate the safety and tolerability of EZN-2208	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.	2 years
Secondary	Assess the PK profile of EZN-2208	The pharmacokinetics of EZN-2208 will be established by measuring the concentration of EZN-2208 and SN-38 over time in patient blood samples.	2 years