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

Enzon Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Carcinoma

Lymphoma

Treatments

Drug: Intravenous EZN-2968 (anti-HIF-1α LNA AS-ODN)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00466583

EZN-2968-01

Details and patient eligibility

About

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.

Full 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 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.

Enrollment

52 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.