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Also known as Menadione Topical Lotion
Menadione · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Group 1 | EXPERIMENTAL | Subjects will be treated if, after starting treatment with an EGFRi, acute signs and symptoms of rash on the face/neck and/or upper chest emerge, that are suspected of being related to the EGFRi treatment. |
| Group 2 | EXPERIMENTAL | Subjects will receive pre-emergent rash treatment starting 1 day prior to beginning EGFRi therapy |
| Name | Type | Description |
|---|---|---|
| Menadione Topical Lotion | DRUG | Menadione Lotion will be applied topically twice a day; beginning when the rash appears during EGFRi therapy. |
Inclusion Criteria: 1. Male or female subjects at least 18 years old; 2. Have been prescribed an approved EGFRI to treat cancer and expect to begin this treatment within 14 days (i.e., any EGFRI that is approved for the treatment of cancer at the time of subject enrollment); 3. For Group 1: Agree t...
Menadione is being developed as a topical lotion for EGFR inhibitor-associated rash, a skin reaction that can occur in patients receiving epidermal growth factor receptor inhibitor cancer therapies. It is a small molecule formulated for topical application in dermatology. The program is investigational and has not been approved for any use.
Menadione is being developed by Assertio Holdings, Inc., which trades under the ticker ASRT. The company is advancing the topical lotion formulation for EGFR inhibitor-associated rash.
Menadione is in Phase 1 development. One Phase 1 trial has been completed, and no trials are currently active. The program remains investigational and is not approved by the FDA for EGFR inhibitor-associated rash or any other indication.
Menadione has been studied in one completed Phase 1 trial, NCT00656786, titled Safety, Tolerability and Systemic Absorption of Menadione Topical Lotion for Epidermal-Growth-Factor-Receptor (EGFR) Inhibitor-Associated Rash. The trial enrolled 18 adults, was randomized, double-blind, and controlled, and ran in the United States and Canada.
Yes. Menadione Topical Lotion is another name for Menadione, the small molecule being developed by Assertio Holdings, Inc. for EGFR inhibitor-associated rash. Both names refer to the same investigational Phase 1 asset.