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BKM120+ temozolomide · 1 trial · 1 indication
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...
BKM120 is an investigational small molecule being studied for use in HER2-positive newly diagnosed primary breast cancer, advanced endometrial cancer, advanced and selected solid tumors, PI3K pathway activated tumors, non-small cell lung cancer, and glioblastoma. It is developed by Novartis AG and is currently in clinical development.
BKM120 is a small molecule that targets the PI3K pathway, which is involved in cell growth and survival. It is being studied in tumors that have PI3K pathway activation, as well as in other cancer types. The drug is designed to inhibit this pathway to potentially slow or stop cancer cell growth.
BKM120 is developed by Novartis AG, a multinational pharmaceutical company listed on the stock exchange under the ticker NVS. Novartis is conducting clinical trials to evaluate the safety and efficacy of BKM120 in various cancer indications.
BKM120 has completed Phase 1 and Phase 2 clinical trials. It is not FDA approved and remains an investigational drug. The completed trials include Phase 1 studies in advanced solid tumors and non-small cell lung cancer, as well as a Phase 2 study in metastatic non-small cell lung cancer.
BKM120 has been studied in four completed clinical trials. These include NCT01068483, a Phase 1 monotherapy study in advanced solid tumors; NCT01155453, a Phase 1 study combining BKM120 with GSK1120212; NCT01297491, a Phase 2 study in metastatic non-small cell lung cancer; and NCT02128724, a Phase 1 study with palliative thoracic radiotherapy.
BKM120 is also known by the generic name buparlisib. It is a PI3K inhibitor developed by Novartis. In clinical trials, it has been evaluated as a monotherapy and in combination with other agents for various solid tumors, including breast cancer and lung cancer.