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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine the maximum tolerated dose (MTD) of EZN-2968.
January 2011
Yes
Anthony Olszanski, MD
Principal Investigator
Fox Chase Cancer Center
United States: Food and Drug Administration
EZN-2968-01
NCT00466583
March 2007
June 2011
Name | Location |
---|---|
Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
Joe Arrington Cancer Research and Treatment Center | Lubbock, Texas 79410-1894 |
Duke University Medical Center | Durham, North Carolina 27710 |