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

Sponsored by:	Enzon Pharmaceuticals, Inc.
Information provided by:	Enzon Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00466583

Purpose

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.

Condition	Intervention	Phase
Carcinoma Lymphoma	Drug: Intravenous EZN-2968 (anti-HIF-1α LNA AS-ODN)	Phase I

MedlinePlus related topics: Cancer Lymphoma

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
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

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

Primary Outcome Measures:

Determine the maximum tolerated dose (MTD) of EZN-2968.

Secondary Outcome Measures:

Determine the pharmacokinetic (PK) profile; Determine the PD profile.

Estimated Enrollment:	40
Study Start Date:	March 2007
Estimated Study Completion Date:	April 2009

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.

Eligibility

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

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
Measurable or non-measurable 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00466583

Contacts

Contact: Om P. Sachdev, Ph.D.	908-541-8720
Contact: Francis C. Gamza, M.D.	908-541-8731

Locations

United States, North Carolina
Duke University Medical Center	Recruiting
Durham, North Carolina, United States, 27710
Contact: Shawna Savage, RN, BSN 919-684-6342 savag005@mc.duke.edu
Principal Investigator: Herbert Hurwitz, MD
United States, Pennsylvania
Fox Chase Cancer Center	Recruiting
Philadelphia, Pennsylvania, United States, 19111-2497
Contact: Peggy McGinn, R.N. 1-800-4-CANCER Peggy.mcginn@fccc.edu
Principal Investigator: Roger B. Cohen, M.D.

Sponsors and Collaborators

Enzon Pharmaceuticals, Inc.

Investigators

Principal Investigator:	Roger B. Cohen, MD	Fox Chase Cancer Center
Principal Investigator:	Herbert Hurwitz, MD	Duke University

More Information

Study ID Numbers:	EZN-2968-01
Study First Received:	April 25, 2007
Last Updated:	September 25, 2007
ClinicalTrials.gov Identifier:	NCT00466583
Health Authority:	United States: Food and Drug Administration

Keywords provided by Enzon Pharmaceuticals, Inc.:

Carcinoma, Lymphoma

Study placed in the following topic categories:

Lymphatic Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders

Lymphoma
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Immune System Diseases

ClinicalTrials.gov processed this record on January 15, 2009