Status:
COMPLETED
Phase 1 Study of EZN-2968 Weekly in Adult Patients With Advanced Solid Tumors or Lymphoma
Lead Sponsor:
Enzon Pharmaceuticals, Inc.
Conditions:
Carcinoma
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 anti...
Detailed Description
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 anti...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT00466583
Start Date
March 1 2007
End Date
June 1 2011
Last Update
July 7 2011
Active Locations (3)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27710
2
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111-2497
3
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, United States, 79410