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This Phase 1 study will determine the safety, tolerability, and pharmacokinetics of vinorelbine liposomes injection (VLI) in patients with advanced solid tumors, non-Hodgkin's lymphoma, or Hodgkin's disease.
The objectives of this study are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Patients are dosed on Day 1 and Day 8 of a 21-day cycle. |
|
| 2 | Experimental | Patients are dosed on Day 1 of a 21-day cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VLI | Drug | Patients are dosed on Day 1 and Day 8 of a 21-day cycle. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the safety and tolerability of VLI. | 21 Days |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the maximum tolerated dose (MTD) | 21 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Sarantopoulos, MD | Cancer Therapy and Research Center, Texas | Principal Investigator |
| Gerald Batist, MD | McGill Centre for Translational Research in Cancer-Jewish General Hospital Clinical Research Unit | Principal Investigator |
| Anthony W. Tolcher, MD | South Texas Accelerated Research Therapeutics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Therapy and Research Center | San Antonio | Texas | 78229 | United States | ||
| South Texas Accelerated Research Therapeutics |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D006689 | Hodgkin Disease |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| VLI |
| Drug |
Patients are dosed on Day 1 of a 21-day cycle. |
|
| San Antonio |
| Texas |
| 78229 |
| United States |
| McGill Centre for Translational Research in Cancer-Jewish General Hospital Clinical Research Unit | Montreal | Quebec | H3T 1E2 | Canada |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |