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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-2208-01)

Sponsor
Enzon Pharmaceuticals, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00520637
Collaborator
(none)
34
Enrollment
2
Locations
17
Patients Per Site

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)
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)
Study Start Date :
May 1, 2007

Outcome Measures

Primary Outcome Measures

  1. Determine the MTD of i.v. EZN-2208 administered q3wk 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 as well as detect preliminary evidence of tumor response activity of EZN-2208 []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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 Northwestern University, Feinberg School of Medicine, Division of Hematology/Oncology Chicago Illinois United States 60611-2927
2 MD Anderson Cancer Center Houston Texas United States 77030

Sponsors and Collaborators

  • Enzon Pharmaceuticals, Inc.

Investigators

  • Principal Investigator: Razelle Kurzrock, MD, M.D. Anderson Cancer Center
  • Principal Investigator: Mary Frances Mulcahy, MD, Northwestern University Feinberg School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00520637
Other Study ID Numbers:
  • EZN-2208-01
First Posted:
Aug 24, 2007
Last Update Posted:
Oct 9, 2009
Last Verified:
Oct 1, 2009
Additional relevant MeSH terms:
Lymphoma

Study Results

No Results Posted as of Oct 9, 2009