Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Idamycin PFS®
Idarubicin · 1 trial · 2 indications
Progression-free survival defined as time from date of randomization to first occurrence of having documented disease progression or death due to any cause, whichever comes first. Progression based on tumor assessments according to Response Evaluation Criteria in Solid Tumors (RECIST). Participants were followed from baseline to disease progression with PFS evaluation at 7 months.
| Arm | Type | Description |
|---|---|---|
| Idarubicin + Ara-C + Vorinostat | EXPERIMENTAL | Idarubicin 12 mg/m\^2 by vein (IV) over 1 hour daily for 3 days (days 4 to 6). Ara-C (Cytarabine) 1.5 g/m\^2 IV as a continuous infusion over 24 hours daily (days 4 to 7). Vorinostat initial dose level 500 mg orally three times a day for 3 days (days 1 to 3). |
| Name | Type | Description |
|---|---|---|
| Idarubicin | DRUG | 12 mg/m\^2 IV over 1 hour daily for 3 days (days 4 to 6) |
| Cytarabine | DRUG | 1.5 g/m\^2 IV as a continuous infusion over 24 hours daily (days 4 to 7) |
| Vorinostat | DRUG | Initial dose level 500 mg orally three times a day for 3 days (days 1 to 3). |
Inclusion Criteria: 1. Diagnosis of 1) AML (World Health Organization (WHO) classification definition of \>/= 20% blasts), or 2) intermediate-2 or high-risk MDS (defined by the IPSS classification2). 2. Patients aged 15 to 65 years; 3. For the initial run-in phase of the study, patients with relaps...