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VLI · 1 trial · 3 indications
| Arm | Type | Description |
|---|---|---|
| 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 |
|---|---|---|
| VLI | DRUG | Patients are dosed on Day 1 and Day 8 of a 21-day cycle. |
Inclusion Criteria: 1. Histologically confirmed solid tumor refractory to standard therapy or for which no standard therapy is known to exist, or relapsed and/or refractory non-Hodgkin's lymphoma or Hodgkin's disease 2. Adequate hematologic, hepatic and renal functions as defined by laboratory test...
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VLI is an investigational small molecule oncology drug being developed by Assertio Holdings, Inc. under the ticker ASRT. It is a liposomal formulation of vinorelbine studied for the treatment of advanced solid tumors, non-Hodgkin's lymphoma, and Hodgkin's disease. VLI remains in clinical development and is not approved.
VLI has been studied for advanced solid tumors, non-Hodgkin's lymphoma, and Hodgkin's disease. The single Phase 1 trial enrolled 67 adults aged 18 years and older across sites in the United States and Canada. VLI is investigational and has not been approved for any indication.
VLI is being developed by Assertio Holdings, Inc., which trades under the ticker ASRT. The company sponsored the Phase 1 study of the liposomal vinorelbine formulation in advanced solid tumors, non-Hodgkin's lymphoma, and Hodgkin's disease.
VLI is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The study was not randomized and was not double blinded, though it used a controlled design. VLI is investigational and has not been approved by the FDA.
VLI has been evaluated in one completed Phase 1 trial, NCT00364676, titled Study of Vinorelbine Liposomes Injection for Advanced Solid Tumors, Non-Hodgkin's Lymphoma or Hodgkin's Disease. It enrolled 67 participants aged 18 years and older in the United States and Canada and did not include healthy volunteers.