Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Isotretinoin · 1 trial · 2 indications
The proportion of participants who experience a Grade \< 2 acneiform rash at week 12 while receiving non-investigational treatment for cancer that targets the mitogen activated protein kinase (MAPK) pathway as classified by the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE version 5.0) and 95% confidence interval will be reported.
| Arm | Type | Description |
|---|---|---|
| Arm A: Isotretinoin | EXPERIMENTAL | Participants randomized to the isotretinoin arm will be enrolled in the iPLEDGE program prior to treatment initiation. Female participants of childbearing potential will undergo a urine or serum pregnancy test as required for iPLEDGE registration. Participants will receive oral isotretinoin daily at a dose based on body weight, ranging from 10 mg to 40 mg, for up to 12 weeks. Treatment will consist of three consecutive 28-day cycles. Participants will undergo follow-up at the end of treatment and at 30 days, 3 months, and 6 months after treatment completion for safety monitoring and post-treatment assessments, until withdrawal from the study or death, whichever occurs first. |
| Arm B: Doxycycline | EXPERIMENTAL | Participants randomized to the doxycycline arm will receive oral doxycycline daily at a body weight-based dose of 50 mg or 100 mg for up to 12 weeks. Treatment will consist of three consecutive 28-day cycles. Participants will undergo follow-up at the end of treatment and at 30 days, 3 months, and 6 months after treatment completion for safety monitoring and post-treatment assessments, until withdrawal from the study or death, whichever occurs first. |
| Name | Type | Description |
|---|---|---|
| Isotretinoin | DRUG | Given Orally |
| Doxycycline | DRUG | Given Orally |
| Blood specimen collection | PROCEDURE | Perform blood draw |
| Photographs of Rash | OTHER | Undergo photography |
| Questionnaires | BEHAVIORAL | Participants will be asked to complete questionnaires |
| Stool Specimen collection | PROCEDURE | Perform stool sample collection |
Inclusion Criteria: 1. Participants must have developed either a grade 2, 3, or 4 rash categorized as acneiform while taking tumor-directed therapy that targets the MAPK pathway. * Acneiform rash will be defined according to CTCAE v5.0 as a disorder characterized by an eruption of papules and p...
Isotretinoin is being studied for the treatment of acneiform drug eruption, a skin condition that can occur in patients receiving drugs that target the MAPK pathway. It is a small molecule being developed by Day One Biopharmaceuticals for this dermatology indication.
Isotretinoin is being developed by Day One Biopharmaceuticals, Inc., a company traded under the ticker DAWN. The company is conducting a Phase 2 clinical trial to evaluate the drug for acneiform drug eruption.
Isotretinoin is in Phase 2 clinical development. It is an investigational drug being studied for acneiform drug eruption and has not been approved by the FDA for this use. The ongoing trial is a controlled, randomized study.
Isotretinoin is being evaluated in a Phase 2 clinical trial with the identifier NCT07629167. The study compares Isotretinoin to Doxycycline for acneiform rash in patients receiving drugs that target the MAPK pathway. It is a randomized, controlled trial with an enrollment of 50 participants.
Isotretinoin is a small molecule being studied for acneiform drug eruption. The specific molecular target of Isotretinoin is not disclosed in the available information, so its mechanism of action for this indication is not detailed.