Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Idamycin®
Idarubicin · 1 trial · 3 indications
MTD is dose level where grade 3-4 sorafenib-attributable toxicity in \<2 of 6 participants. Dose-Limiting Toxicity graded according to the NCI Common Toxicity Criteria version 3.0.
| Arm | Type | Description |
|---|---|---|
| Sorafenib + Idarubicin + Ara-C | EXPERIMENTAL | Sorafenib starting dose 400 mg orally for 7 days; Idarubicin 12 mg/m\^2 intravenous (IV) daily (days 1-3); and Ara-C 1.5 g/m\^2 IV over 24 hours daily (days 1-4) |
| Name | Type | Description |
|---|---|---|
| Idarubicin | DRUG | 12 mg/m\^2 IV over 1 hour daily (days 1-3) |
| Sorafenib | DRUG | Starting dose 400 mg by mouth for 7 days |
| Ara-C | DRUG | 1.5 g/m\^2 IV over 24 hours daily (days 1-4) |
Inclusion Criteria: 1. Diagnosis of 1) AML (World Health Organization classification definition of \> 20% blasts), or 2) high risk MDS (defined as the presence of \> 10% blasts). 2. Patients aged 15 to 60 years are eligible. Patients older than 60 who are deemed fit to receive intensive chemotherap...