Study of EZN-2208 Pediatric Patients With Solid Tumors

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Solid Tumors

Intervention / Treatment
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* Drug: EZN-2208


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EZN-2208<br>Cytotoxic Agent | Drug: EZN-2208<br>* Experimental<br>* Other names: PEG-SN38;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patients with non-CNS or CNS tumors, Pediatric patients with Relapsed/Refractory Solid Tumors