A Phase I, Study to Evaluate the Safety and Tolerability of Intravenous EZN-2208 in Patients With Advanced Solid Tumors or Lymphoma (EZN-2208-02)

Phase 1

Completed

• Conditions: Lymphoma; Advanced Solid Tumors

• Registration Number: NCT00520390
• Lead Sponsor: Enzon Pharmaceuticals, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2007-08-23
• Study First Submitted QC: 2007-08-23
• Study First Posted: 2007-08-24
• Status Verified: 2010-04
• Last Update Submitted: 2010-04-01
• Last Update Posted: 2010-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Determine the MTD of i.v. EZN-2208 administered weekly for 3 weeks in a 4-week cycle and recommended Phase 2 dose of i.v. EZN-2208

Secondary Outcome Measures

Name	Time	Method
Evaluate the safety and tolerability of EZN-2208, assess the pharmacokinetic PK profile of EZN-2208, SN38, and SN38G.	1.5 years

Trial Locations

Locations (1)

South Texas Accelerated Research Therapeutics; 🇺🇸 San Antonio, Texas, United States