Phase 1 Study of EZN-2968 Weekly in Adult Patients With Advanced Solid Tumors or Lymphoma
Primary Purpose
Carcinoma, Lymphoma
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Intravenous EZN-2968 (anti-HIF-1α LNA AS-ODN)
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoma focused on measuring Carcinoma, Lymphoma
Eligibility Criteria
Inclusion Criteria: Patients must meet all of the following criteria to be eligible for enrollment into the study.
- Histologically or cytologically confirmed diagnosis of advanced and/or metastatic solid tumor or lymphoma (Hodgkin's or non-Hodgkin's)
- Patients who have failed standard therapy and have no known effective therapy available to them
- Patients may have a tumor amenable to biopsy
- Measurable or evaluable disease.
- Age 18 years or older
Exclusion Criteria: Patients meeting any of the following exclusion criteria will not be eligible for enrollment.
- Concurrent serious medical illness
- Known, clinically suspected, or history of central nervous system (CNS) tumor involvement
- 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) before the scheduled administration of EZN-2968. Luteinizing hormone-releasing hormone (LHRH) agonist therapy is permitted for patients with hormone refractory prostate cancer.
Sites / Locations
- Duke University Medical Center
- Fox Chase Cancer Center
- Joe Arrington Cancer Research and Treatment Center
Outcomes
Primary Outcome Measures
Determine the maximum tolerated dose (MTD) of EZN-2968.
Secondary Outcome Measures
Determine the pharmacokinetic (PK) profile; Determine the PD profile.
Full Information
NCT ID
NCT00466583
First Posted
April 25, 2007
Last Updated
July 5, 2011
Sponsor
Enzon Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00466583
Brief Title
Phase 1 Study of EZN-2968 Weekly in Adult Patients With Advanced Solid Tumors or Lymphoma
Official Title
A Phase 1, Open-Label, Dose Escalation Study Evaluating the Safety and Tolerability of EZN-2968, a Locked Nucleic Acid Antisense Oligonucleotide Against Hypoxia-Inducible Factor-1α, Administered as a Weekly 2-Hour Intravenous Infusion in Adult Patients With Advanced Solid Tumors or Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Enzon Pharmaceuticals, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a Phase 1, open-label, non-randomized, dose-escalation study to determine the maximum tolerated dose (MTD), safety, tolerance, and pharmacologic profile of EZN-2968, a locked nucleic acid antisense oligonucleotide against hypoxia-inducible factor 1α administered as a 2-hour intravenous (i.v.) infusion weekly for 3 weeks per 6-week cycle. In patients treated at a recommended Phase 2 dose of EZN-2968, dose intensification will proceed by maintaining the dose, but gradually increasing the number of doses per 6-week cycle. Up to 3 intensification cohorts will receive the recommended Phase 2 dose of EZN-2968.
Detailed Description
This is a Phase 1, open-label, non-randomized, dose-escalation study to determine the maximum tolerated dose (MTD), safety, tolerance, and pharmacologic profile of EZN-2968, a locked nucleic acid antisense oligonucleotide against hypoxia-inducible factor 1α (anti-HIF-1α LNA AS ODN) administered as a 2-hour intravenous (i.v.) infusion weekly for 3 weeks per 6-week cycle. In patients treated at a recommended Phase 2 dose of EZN-2968, dose intensification will proceed by maintaining the dose, but gradually increasing the number of doses per 6-week cycle. Up to 3 intensification cohorts will receive the recommended Phase 2 dose of EZN-2968.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Lymphoma
Keywords
Carcinoma, Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Intravenous EZN-2968 (anti-HIF-1α LNA AS-ODN)
Intervention Description
IV infusion of EZN 2968 given in 6 week cycles for (3 weeks on 3 weeks off) until recommended phase 2 dose identified. Up to 3 intensification cohorts will receive the recommended Phase 2 dose of EZN-2968.
Primary Outcome Measure Information:
Title
Determine the maximum tolerated dose (MTD) of EZN-2968.
Time Frame
January 2011
Secondary Outcome Measure Information:
Title
Determine the pharmacokinetic (PK) profile; Determine the PD profile.
Time Frame
June 2011
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients must meet all of the following criteria to be eligible for enrollment into the study.
Histologically or cytologically confirmed diagnosis of advanced and/or metastatic solid tumor or lymphoma (Hodgkin's or non-Hodgkin's)
Patients who have failed standard therapy and have no known effective therapy available to them
Patients may have a tumor amenable to biopsy
Measurable or evaluable disease.
Age 18 years or older
Exclusion Criteria: Patients meeting any of the following exclusion criteria will not be eligible for enrollment.
Concurrent serious medical illness
Known, clinically suspected, or history of central nervous system (CNS) tumor involvement
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) before the scheduled administration of EZN-2968. Luteinizing hormone-releasing hormone (LHRH) agonist therapy is permitted for patients with hormone refractory prostate cancer.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony Olszanski, MD
Organizational Affiliation
Fox Chase Cancer Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Herbert Hurwitz, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jose Figueroa, MD
Organizational Affiliation
Joe Arrington Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111-2497
Country
United States
Facility Name
Joe Arrington Cancer Research and Treatment Center
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79410
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Phase 1 Study of EZN-2968 Weekly in Adult Patients With Advanced Solid Tumors or Lymphoma
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