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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)

This study has been completed.
Sponsor:
Information provided by:
Enzon Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00520390
First received: August 23, 2007
Last updated: April 1, 2010
Last verified: April 2010
  Purpose

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 Intervention Phase
Lymphoma
Advanced Solid Tumors
Drug: EZN-2208
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Enzon Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • 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:
  • Evaluate the safety and tolerability of EZN-2208, assess the pharmacokinetic PK profile of EZN-2208, SN38, and SN38G. [ Time Frame: 1.5 years ]

Estimated Enrollment: 34
Study Start Date: May 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00520390

Locations
United States, Texas
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00520390     History of Changes
Other Study ID Numbers: EZN-2208-02
Study First Received: August 23, 2007
Last Updated: April 1, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lymphoma
Neoplasms
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on November 25, 2014