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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous EZN-2968 (anti-HIF-1α LNA AS-ODN) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Determine the maximum tolerated dose (MTD) of EZN-2968. | January 2011 |
| Measure | Description | Time Frame |
|---|---|---|
| Determine the pharmacokinetic (PK) profile; Determine the PD profile. | June 2011 |
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Anthony Olszanski, MD | Fox Chase Cancer Center | Principal Investigator |
| Herbert Hurwitz, MD | Duke University | Principal Investigator |
| Jose Figueroa, MD | Joe Arrington Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States | ||
| Fox Chase Cancer Center |
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| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
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| Philadelphia |
| Pennsylvania |
| 19111-2497 |
| United States |
| Joe Arrington Cancer Research and Treatment Center | Lubbock | Texas | 79410 | United States |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |