A Phase 1 interventional study of Intravenous EZN-2968 (anti-HIF-1α LNA AS-ODN) in Carcinoma and Lymphoma, sponsored by Enzon Pharmaceuticals, Inc.. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-07-07.
Sponsored by Enzon Pharmaceuticals, Inc. · Phase 1, Interventional, and Treatment
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.
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.
6,719 studies on the registry are indexed under Carcinoma; 1,142 are open to participants now.
This study's enrollment of 52 is above the median of 45 across 5,153 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Enzon Pharmaceuticals, Inc. is the lead sponsor of 15 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria: Patients must meet all of the following criteria to be eligible for enrollment into the study.
Exclusion Criteria: Patients meeting any of the following exclusion criteria will not be eligible for enrollment.
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.
Determine the maximum tolerated dose (MTD) of EZN-2968.
Time frame: January 2011
Determine the pharmacokinetic (PK) profile; Determine the PD profile.
Time frame: June 2011
The record gives a start of Mar 2007, a primary completion of Jun 2011 and a completion of Jun 2011. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Jul 2011. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: EZN 2968
Enzon Pharmaceuticals, Inc.