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

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

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lymphoma

U.S. FDA Resources

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

Primary Outcome Measures:

Determine the maximum tolerated dose (MTD) of EZN-2968. [ Time Frame: January 2011 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Determine the pharmacokinetic (PK) profile; Determine the PD profile. [ Time Frame: June 2011 ] [ Designated as safety issue: Yes ]

Enrollment:	52
Study Start Date:	March 2007
Study Completion Date:	June 2011
Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Intervention Details:

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.

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.

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
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

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

Locations

United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111-2497
United States, Texas
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

More Information

No publications provided

Responsible Party:	Noah Berkowitz, MD/Medical Monitor, Enzon Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00466583 History of Changes
Other Study ID Numbers:	EZN-2968-01
Study First Received:	April 25, 2007
Last Updated:	July 5, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Enzon Pharmaceuticals, Inc.:

Carcinoma, Lymphoma

Additional relevant MeSH terms:

Carcinoma
Lymphoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms

Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on May 22, 2012