Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01473901 | A Phase I Dose Escalation Study of BKM120 With Radiation Therapy and Temozolomide in Patients With Newly Diagnosed Glioblastoma | PHASE1 | COMPLETED | 38 | — | — | Dec 30, 2011 | May 17, 2017 | Dec 9, 2020 | 8 | United States, Australia +2 |
Per DLT criteria as defined in protocol
| Arm | Type | Description |
|---|---|---|
| BKM120 + Temozolomide (Concomitant Phase) | EXPERIMENTAL | Cranial radiation: Days 1 - 5 every 7 days for 42 days60 Gy in 30 fractions; Temozolomide: 75 mg/m2 Daily, orally; BKM120: 0, or 40, or 60, or 80 mg/d Daily, orally or Days 1-5 every 7 days, orally |
| BKM120 + temozolomide with/without radiotherapy | EXPERIMENTAL | Adjuvant phase cycle 1: Temozolomide 150 mg/m2 - Days 1 - 5 every 28 days Daily; BKM120 60, or 80, or 100 mg/d; Adjuvant phase cycle 2+: Temozolomide 200\* mg/m2 - Day 1 \~ 5 every 28 days Daily BKM120 0, or 40, or 60, or 80 or 100 mg/d |
| Name | Type | Description |
|---|---|---|
| BKM120 + temozolomide | DRUG | The investigational drug, BKM120, will be supplied as 10-mg and 50-mg hard gelatin capsules. BKM120 will be administered on a once daily dosing schedule at a dose of 40 mg, or 60 mg, or 80 mg, or 100 mg (p.o.), in combination with the approved dosing of temozolomide and SoC delivery of cranial irradiation for GBM. The patient will be dosed with BKM120 on a flat scale of mg/day and the dose of BKM120 will not be adjusted to body weight or body surface area. Patients should not eat for 2 hours after the administration of BKM120. Temozolomide in 5 mg, 20 mg, 100 mg, 140 mg, 180 mg or 250 mg capsules will be administered in combination with the investigational drug BKM120. |
| BKM120 +temozolomide with/without radiotherapy | DRUG | The investigational drug, BKM120, will be supplied as 10-mg and 50-mg hard gelatin capsules. BKM120 will be administered on a continuous once daily dosing schedule at a dose of 40 mg, or 60 mg, or 80 mg, or 100 mg (p.o.), in combination with the approved dosing of temozolomide and SoC delivery of cranial irradiation for GBM. The patient will be dosed with BKM120 on a flat scale of mg/day and the dose of BKM120 will not be adjusted to body weight or body surface area. Patients should not eat for 2 hours after the administration of BKM120. Temozolomide in 5 mg, 20 mg, 100 mg, 140 mg, 180 mg or 250 mg capsules will be administered in combination with the investigational drug BKM120. |
Inclusion Criteria: * Patient is ≥ 18 years of age on the day of consent signature * Patient with histologically demonstrated, previously untreated glioblastoma * Patient may have received initial treatment for GBM as follows: * For patients enrolled into Stage I, they must have received at leas...