Study of EZN-2208 Pediatric Patients With Solid Tumors

Phase 1

Terminated

• Conditions: Solid Tumors
• Interventions: Drug: EZN-2208

• Registration Number: NCT01295697
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-12-03
• Study First Submitted QC: 2011-02-11
• Study First Posted: 2011-02-14
• Status Verified: 2012-03
• Primary Completion: 2012-08
• Study Completion: 2013-01
• Last Update Submitted: 2022-01-29
• Last Update Posted: 2022-02-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EZN-2208	EZN-2208	Cytotoxic Agent

Primary Outcome Measures

Name	Time	Method
Determine the MTD and recommended phase 2 dose of i.v. EZN-2208 administered q3wk.	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

Name	Time	Method
Assess evidence of tumor response activity of EZN-2208	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	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	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.

Trial Locations

Locations (4)

Lia Gore, MD; 🇺🇸 Aurora, Colorado, United States

Suzanne Shusterman, MD; 🇺🇸 Boston, Massachusetts, United States

Rochelle Bagatell, MD (Principal Investigator); 🇺🇸 Philadelphia, Pennsylvania, United States

Jodi Muscal, MD; 🇺🇸 Houston, Texas, United States