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

NCT00466583 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2011-07-07

No results posted yet for this study

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

Interventions

DRUG

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.

Sponsors & Collaborators

  • Enzon Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Anthony Olszanski, MD · Fox Chase Cancer Center

  • Herbert Hurwitz, MD · Duke University

  • Jose Figueroa, MD · Joe Arrington Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2011-06-30
Completion
2011-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00466583 on ClinicalTrials.gov