This trial is active, not recruiting.

Condition solid tumors
Treatment ezn-2208
Phase phase 1/phase 2
Sponsor Enzon Pharmaceuticals, Inc.
Start date February 2010
End date August 2012
Trial size 24 participants
Trial identifier NCT01295697, EZN-2208-05


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Cytotoxic Agent
ezn-2208 PEG-SN38

Primary Outcomes

Determine the MTD and recommended phase 2 dose of i.v. EZN-2208 administered q3wk.
time frame: 2 years

Secondary Outcomes

Assess evidence of tumor response activity of EZN-2208
time frame: 2 years
Evaluate the safety and tolerability of EZN-2208
time frame: 2 years
Assess the PK profile of EZN-2208
time frame: 2 years

Eligibility Criteria

Male or female participants from 1 year up to 21 years old.

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

Additional Information

Official title A Phase 1/2 Study of EZN-2208 in Children, Adolescents, and Young Adults With Relapsed or Refractory Solid Tumors
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2012.
Information provided to ClinicalTrials.gov by Enzon Pharmaceuticals, Inc..