Study of EZN-2208 Pediatric Patients With Solid Tumors

• Status: Unknown status
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Enzon Pharmaceuticals, Inc.
• Treatments: Camptothecin

Criteria

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