Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Vorasidenib · 2 trials · 2 indications
The time from date of randomization to date of first documented radiographic progressive disease (PD), as assessed by the Blinded Independent Review Committee (BIRC), or date of death due to any cause, whichever occurs earlier.
Maximum observed plasma concentration of vorasidenib in substudy A
Time to maximum observed plasma concentration of vorasidenib in substudy A
Area under the plasma concentration versus time curve (AUC) from time 0 to the last quantifiable concentration (AUC0-t) of vorasidenib in substudy A
AUC from time 0 extrapolated to infinity (AUC0-inf) of vorasidenib in substudy A
Maximum observed plasma concentration of vorasidenib in substudy B
Time to maximum observed plasma concentration of vorasidenib in substudy B
Area under the plasma concentration versus time curve (AUC) from time 0 to the last quantifiable concentration (AUC0-t) of vorasidenib in substudy B
AUC from time 0 extrapolated to infinity (AUC0-inf) of vorasidenib in substudy B
| Arm | Type | Description |
|---|---|---|
| Randomized Double-Blind Phase: Vorasidenib | EXPERIMENTAL | - |
| Randomized Double-Blind Phase: Placebo | PLACEBO_COMPARATOR | - |
| Fasting condition / Low-fat meal | EXPERIMENTAL | A single oral dose of 1×40 mg vorasidenib tablet administered under fasted conditions or following a low-fat meal. |
| Low-fat meal / Fasted condition | EXPERIMENTAL | A single oral dose of 1×40 mg vorasidenib tablet administered following a low-fat meal or under fasted conditions. |
| Vorasidenib | EXPERIMENTAL | Single oral dose of vorasidenib 2×10 mg tablets administered on Day 1. |
| Vorasidenib and ciprofloxacin | EXPERIMENTAL | Single oral dose of vorasidenib 2×10 mg tablets administered on Day 1 and twice daily (morning and evening) oral doses of ciprofloxacin 1×500 mg tablet on Days 1 through 14. |
| Name | Type | Description |
|---|---|---|
| Vorasidenib | DRUG | For oral administration once daily |
| Placebo | DRUG | For oral administration once daily |
| Vorasidenib 40 mg Oral Tablet | DRUG | Single oral dose of 1×40 mg vorasidenib tablet administered : * under fasted conditions (all subjects will fast overnight for at least 10 hours prior to dosing and for at least 4 hours after dosing. * or following a low fat meal (approximatively 400 to 500 calories) (Substudy A) |
| Ciprofloxacin 500 mg Oral Tablet | DRUG | Twice daily (morning and evening) oral doses of ciprofloxacin 1×500 mg tablet on Days 1 through 14 (Substudy B) |
| Vorasidenib 10 mg Oral Tablet | DRUG | Single oral dose of vorasidenib 2×10 mg tablets administered on Day 1 (Substudy B) |
Inclusion Criteria: * Be at least 12 years of age (for Randomized Double-Blind phase) and weigh at least 40 kg. * Have a Karnofsky Performance Scale (KPS) score (for participants ≥16 years of age) or Lansky Play Performance Scale (LPPS) score (for participants \<16 years of age) of ≥80%. * Have Gra...