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BKM120 and Olaparib · 1 trial · 2 indications
To determine the maximally tolerated dose (MTD) and recommended phase 2 dose (RP2D) of the combination of BKM120 and olaparib, and the combination of BYL719 and olaparib in patients with recurrent TNBC and HGSC.
| Arm | Type | Description |
|---|---|---|
| Arm BKM | EXPERIMENTAL | BKM120 and Olaparib |
| Arm BYL | EXPERIMENTAL | BYL719 and Olaparib |
| Name | Type | Description |
|---|---|---|
| BKM120 and Olaparib | DRUG | Olaparib twice daily (starting dose 50 mg) and BKM120 once daily (starting dose 40 mg). Both drugs are given orally. |
| BYL719 and Olaparib | DRUG | Olaparib twice daily (starting dose 100 mg) and BYL719 once daily (starting dose 250 mg). Both drugs are given orally. |
Inclusion Criteria: * Histologically or cytologically confirmed recurrent high grade serous ovarian cancer or triple negative breast cancer * Subjects with recurrent, metastatic triple negative breast cancer must have had at least 1 chemotherapy regimen for metastatic breast cancer or have develope...
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BKM120 is an investigational small molecule being studied in oncology. Clinical trials have evaluated it in advanced solid tumors, breast cancer, HER2-positive primary breast cancer, glioblastoma, thymoma, and advanced carcinomas with squamous cell histology. It has also been studied in patients with hepatic impairment. BKM120 is not approved and remains in clinical development.
BKM120 is a small molecule that targets the PI3K pathway. Clinical trials have enrolled patients with PI3K pathway activated tumors, indicating its mechanism involves inhibiting this signaling pathway. The drug is being investigated for its potential role in treating cancers driven by PI3K activation.
BKM120 is being developed by Novartis AG, which trades under the ticker NVS. The company has sponsored multiple clinical trials of the drug across various oncology indications. Novartis is responsible for the investigational development of BKM120.
BKM120 has completed Phase 1 and Phase 2 clinical trials. The completed trials include Phase 1 studies in glioblastoma and hepatic impairment, and Phase 2 studies in HER2-positive breast cancer and PI3K-activated tumors. BKM120 is investigational and has not received FDA approval.
BKM120 has been studied in four completed clinical trials. These include NCT01473901, a Phase 1 dose escalation study in newly diagnosed glioblastoma; NCT01727128, a pharmacokinetic study in hepatic impairment; NCT01816594, a Phase 2 neoadjuvant study in HER2-positive breast cancer; and NCT01833169, a Phase 2 study in PI3K-activated tumors.
BKM120 is also known as buparlisib. The drug has been referred to by both names in clinical research. BKM120 is the investigational code name used by Novartis, while buparlisib is the generic name. Both names refer to the same small molecule PI3K inhibitor.