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

This study has been completed.
Sponsor:
Information provided by:
Enzon Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00466583
First received: April 25, 2007
Last updated: July 5, 2011
Last verified: July 2011

April 25, 2007
July 5, 2011
March 2007
June 2011   (final data collection date for primary outcome measure)
Determine the maximum tolerated dose (MTD) of EZN-2968. [ Time Frame: January 2011 ] [ Designated as safety issue: Yes ]
Determine the maximum tolerated dose (MTD) of EZN-2968.
Complete list of historical versions of study NCT00466583 on ClinicalTrials.gov Archive Site
Determine the pharmacokinetic (PK) profile; Determine the PD profile. [ Time Frame: June 2011 ] [ Designated as safety issue: Yes ]
Determine the pharmacokinetic (PK) profile; Determine the PD profile.
Not Provided
Not Provided
 
Phase 1 Study of EZN-2968 Weekly in Adult Patients With Advanced Solid Tumors or Lymphoma
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 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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Carcinoma
  • Lymphoma
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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
52
June 2011
June 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00466583
EZN-2968-01
No
Noah Berkowitz, MD/Medical Monitor, Enzon Pharmaceuticals
Enzon Pharmaceuticals, Inc.
Not Provided
Principal Investigator: Anthony Olszanski, MD Fox Chase Cancer Center
Principal Investigator: Herbert Hurwitz, MD Duke University
Principal Investigator: Jose Figueroa, MD Joe Arrington Cancer Center
Enzon Pharmaceuticals, Inc.
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP