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

NCT ID: NCT00466583

Last Updated: 2011-07-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2011-06-30

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.

Conditions

Carcinoma; Lymphoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Intravenous EZN-2968 (anti-HIF-1α LNA AS-ODN)

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Enzon Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Enzon Pharmaceuticals

Principal Investigators

Anthony Olszanski, MD

Role: PRINCIPAL_INVESTIGATOR

Fox Chase Cancer Center

Herbert Hurwitz, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Jose Figueroa, MD

Role: PRINCIPAL_INVESTIGATOR

Joe Arrington Cancer Center

Locations

Duke University Medical Center

Durham, North Carolina, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Joe Arrington Cancer Research and Treatment Center

Lubbock, Texas, United States

Countries

United States

Other Identifiers

EZN-2968-01

Identifier Type: -

Identifier Source: org_study_id