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

NCT00466583 | Completed Phase 1

• 1 other identifier: EZN-2968-01
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 3

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.

Conditions

Carcinoma; Lymphoma

Keywords

Carcinoma, Lymphoma

Outcome Measures

Primary Outcomes (1)

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

  January 2011

Secondary Outcomes (1)

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

  June 2011

Interventions

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

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Enzon Pharmaceuticals, Inc.: lead

Study Sites (3)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111-2497, United States

Location

Joe Arrington Cancer Research and Treatment Center

Lubbock, Texas, 79410, United States

Location

MeSH Terms

Conditions

Carcinoma; Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Anthony Olszanski, MD

  Fox Chase Cancer Center

  PRINCIPAL INVESTIGATOR

• Herbert Hurwitz, MD

  Duke University

  PRINCIPAL INVESTIGATOR

• Jose Figueroa, MD

  Joe Arrington Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 25, 2007
• First Posted: April 27, 2007
• Study Start: March 1, 2007
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: July 7, 2011

Record last verified: 2011-07

Locations

US (3)