Back to resultsA Phase I, Study to Evaluate the Safety and Tolerability of Intravenous EZN-2208 in Patients With Advanced Solid Tumors or Lymphoma (EZN-2208-02)
Primary Purpose
Lymphoma, Advanced Solid Tumors
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
EZN-2208
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoma
Eligibility 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.
Sites / Locations
- South Texas Accelerated Research Therapeutics
Outcomes
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.
Full Information
NCT ID
NCT00520390
First Posted
August 23, 2007
Last Updated
April 1, 2010
Sponsor
Enzon Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00520390
Brief Title
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)
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 Type
Interventional
2. Study Status
Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Enzon Pharmaceuticals, Inc.
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Advanced Solid Tumors
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
34 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
EZN-2208
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Evaluate the safety and tolerability of EZN-2208, assess the pharmacokinetic PK profile of EZN-2208, SN38, and SN38G.
Time Frame
1.5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amita Patnaik, M.D.
Organizational Affiliation
South Texas Accelerated Research Therapeutics
Official's Role
Principal Investigator
Facility Information:
Facility Name
South Texas Accelerated Research Therapeutics
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
30957581
Citation
Park EJ, Choi J, Lee KC, Na DH. Emerging PEGylated non-biologic drugs. Expert Opin Emerg Drugs. 2019 Jun;24(2):107-119. doi: 10.1080/14728214.2019.1604684. Epub 2019 Apr 19.
Results Reference
derived
Learn more about this trial
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)
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