Study of EZN-2208 Pediatric Patients With Solid Tumors

Enzon Pharmaceuticals

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Solid Tumors

Treatments: Drug: EZN-2208

Study type: Interventional

Funder types: Industry

Identifiers

NCT01295697

EZN-2208-05

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 1 to 21 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

EZN-2208

Experimental group

Description:

Cytotoxic Agent

Treatment:

Drug: EZN-2208