Study of EZN-2208 Pediatric Patients With Solid Tumors

NCT ID: NCT01295697

Last Updated: 2022-02-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2013-01-31

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.

Conditions

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Solid Tumors

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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EZN-2208

Cytotoxic Agent

Group Type EXPERIMENTAL

EZN-2208

Intervention Type DRUG

Experimental

Interventions

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EZN-2208

Experimental

Intervention Type DRUG

Other Intervention Names

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PEG-SN38

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
Minimum Eligible Age

1 Year

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Enzon Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rochelle Bagatell, MD

Role: STUDY_CHAIR

Developmental Therapeutics Program, The Children's Hospital of Philadelphia, CTRB 4022; 3501 Civic Center Blvd. Philadelphia, PA 19104

Locations

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Lia Gore, MD

Aurora, Colorado, United States

Site Status

Suzanne Shusterman, MD

Boston, Massachusetts, United States

Site Status

Rochelle Bagatell, MD (Principal Investigator)

Philadelphia, Pennsylvania, United States

Site Status

Jodi Muscal, MD

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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EZN-2208-05

Identifier Type: -

Identifier Source: org_study_id

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