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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)

Sponsor
Enzon Pharmaceuticals, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00520390
Collaborator
(none)
34
Enrollment
1
Location

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase I, Multicenter, Open-Label, Dose-Escalation Study Evaluating the Safety and Tolerability of Intravenous EZN-2208 PEG-SN38) Administered Weekly for 3 Weeks in 4-Week Cycles in Patients With Advanced Solid Tumors or Ymphoma (EZN-2208-02)
Study Start Date :
May 1, 2007

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Evaluate the safety and tolerability of EZN-2208, assess the pharmacokinetic PK profile of EZN-2208, SN38, and SN38G. [1.5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 South Texas Accelerated Research Therapeutics San Antonio Texas United States 78229

Sponsors and Collaborators

  • Enzon Pharmaceuticals, Inc.

Investigators

  • Principal Investigator: Amita Patnaik, M.D., South Texas Accelerated Research Therapeutics

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00520390
Other Study ID Numbers:
  • EZN-2208-02
First Posted:
Aug 24, 2007
Last Update Posted:
Apr 2, 2010
Last Verified:
Apr 1, 2010
Additional relevant MeSH terms:
Lymphoma

Study Results

No Results Posted as of Apr 2, 2010