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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
Enzon Pharmaceuticals, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma focused on measuring Carcinoma, Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
April 25, 2007
Last Updated
July 5, 2011
Sponsor
Enzon Pharmaceuticals, Inc.
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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

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Phase 1 Study of EZN-2968 Weekly in Adult Patients With Advanced Solid Tumors or Lymphoma

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