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

Sponsor
Enzon Pharmaceuticals, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00466583
Collaborator
(none)
52
Enrollment
3
Locations
51
Duration (Months)
17.3
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Intravenous EZN-2968 (anti-HIF-1α LNA AS-ODN)
 Phase 1

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
52 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date :
Mar 1, 2007
Actual Primary Completion Date :
Jun 1, 2011
Actual Study Completion Date :
Jun 1, 2011

Outcome Measures

Primary Outcome Measures

  1. Determine the maximum tolerated dose (MTD) of EZN-2968. [January 2011]

Secondary Outcome Measures

  1. Determine the pharmacokinetic (PK) profile; Determine the PD profile. [June 2011]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Duke University Medical Center Durham North Carolina United States 27710
2 Fox Chase Cancer Center Philadelphia Pennsylvania United States 19111-2497
3 Joe Arrington Cancer Research and Treatment Center Lubbock Texas United States 79410

Sponsors and Collaborators

  • Enzon Pharmaceuticals, Inc.

Investigators

  • Principal Investigator: Anthony Olszanski, MD, Fox Chase Cancer Center
  • Principal Investigator: Herbert Hurwitz, MD, Duke University
  • Principal Investigator: Jose Figueroa, MD, Joe Arrington Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00466583
Other Study ID Numbers:
  • EZN-2968-01
First Posted:
Apr 27, 2007
Last Update Posted:
Jul 7, 2011
Last Verified:
Jul 1, 2011
Keywords provided by , ,
Carcinoma, Lymphoma
Additional relevant MeSH terms:
Lymphoma

Study Results

No Results Posted as of Jul 7, 2011