A Phase I, Study to Evaluate the Safety and Tolerability of Intravenous EZN-2208 in Patients With Advanced Solid Tumors or Lymphoma (EZN-2208-01)

Lymphoma Clinical Trial

Official title:

A Phase I, Multicenter, Open-Label, Dose-Escalation Study Evaluating the Safety and Tolerability of Intravenous EZN-2208 (PEG-SN38) Administered Every 3 Weeks in Patients With Advanced Solid Tumors or Lymphoma (EZN-2208-01)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00520637
• Other study ID #: EZN-2208-01
• Status: Completed
• Phase: Phase 1
• First received: August 23, 2007
• Last updated: October 8, 2009
• Start date: May 2007

Study information

• Verified date: October 2009
• Source: Enzon Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical research study is to find the highest tolerable dose of EZN-2208 that can be given to patients with advanced cancer or lymphoma. The safety of the study drug and its effect on the disease will also be studied.

Enzon will also perform pharmacokinetic (PK) testing of EZN-2208. PK testing measures the amount of a drug in the body at different time points.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically or cytologically confirmed diagnosis of advanced and/or metastatic solid tumor or lymphoma that is refractory to standard therapy

• Measurable or evaluable disease

• Score of 0 to 2 on the ECOG performance scale

Exclusion Criteria:

• Concurrent serious medical illness

• Known, clinically suspected, or history of central nervous system (CNS) tumor involvement

• Active diarrhea

• Known history of coagulation disorder

• Patients requiring cytochrome P450 3A4 (CYP3A4) enzyme inducing medications

• Requirement for ketoconazole or other strong inhibitor of CYP3A4 enzymes

• Prior chemotherapy, immunotherapy, investigational agent, or other therapy used to treat the cancer within 4 weeks (6 weeks for prior treatment with mitomycin C or nitrosoureas) prior to the scheduled administration of EZN-2208

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Lymphoma

Intervention

Drug:
• EZN-2208

Locations

Country	Name	City	State
United States	Northwestern University, Feinberg School of Medicine, Division of Hematology/Oncology	Chicago	Illinois
United States	MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Enzon Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the MTD of i.v. EZN-2208 administered q3wk and recommended Phase 2 dose of i.v. EZN-2208
Secondary	Evaluate the safety and tolerability of EZN-2208, assess the pharmacokinetic PK profile of EZN-2208, SN38, and SN38G as well as detect preliminary evidence of tumor response activity of EZN-2208