Know Cancer

or
forgot password

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


Phase 1
18 Years
N/A
Not Enrolling
Both
Carcinoma, Lymphoma

Thank you

Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

January 2011

Safety Issue:

Yes

Principal Investigator

Anthony Olszanski, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fox Chase Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

EZN-2968-01

NCT ID:

NCT00466583

Start Date:

March 2007

Completion Date:

June 2011

Related Keywords:

  • Carcinoma
  • Lymphoma
  • Carcinoma, Lymphoma
  • Carcinoma
  • Lymphoma

Name

Location

Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Joe Arrington Cancer Research and Treatment CenterLubbock, Texas  79410-1894
Duke University Medical CenterDurham, North Carolina  27710