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Also known as BYL719
BYL-719 · 1 trial · 1 indication
Phase I was a 3+3 dose escalation design (three dose levels of alpelisib: 250mg, 300mg, and 350mg orally once daily, continuous dosing) with dose-limiting toxicities (DLT) assessed during the first treatment cycle. If two or more of the six patients experienced a dose-limiting toxicity, dosing escalation would cease and maximum tolerated dose (MTD) would be reached. RP2D was the next lower dose at which \<1/6 subjects experienced a DLT.
ORR includes complete response (CR) plus partial response (PR). As evaluated per RECIST version 1.1.
| Arm | Type | Description |
|---|---|---|
| Dose level 1 BYL-719/alpelisib (250mg)+Nab-paclitaxel | EXPERIMENTAL | BYL-719 (alpelisib): 250mg daily on day 1-28 Nab-paclitaxel: 100mg/m2 IV days 1, 8, 15 of each 28 day cycle (Window for Nab-paclitaxel is +/- 1 day) |
| Dose level 2 BYL-719 (alpelisib) (300mg)+Nab-paclitaxel | EXPERIMENTAL | BYL-719 (alpelisib): 300mg by mouth daily on day 1-28 of each 28 day cycle Nab-paclitaxel: 100mg/m2 given IV on days 1, 8, 15 of each 28 day cycle (Window for Nab-paclitaxel is +/- 1 day) |
| Dose level 3 BYL-719 (alpelisib) (350mg)+Nab-paclitaxel | EXPERIMENTAL | BYL-719 (alpelisib): 350mg by mouth daily on day 1-28 of each 28 day cycle Nab-paclitaxel: 100mg/m2 given IV on days 1, 8, 15 of each 28 day cycle (Window for Nab-paclitaxel is +/- 1 day) |
| BYL-719 (alpelisib) Dose Expansion | EXPERIMENTAL | BYL-719 (alpelisib): RP2D from Phase I by mouth daily on day 1-28 of each 28 day cycle Nab-paclitaxel: 100mg/m2 given IV on days 1, 8, 15 of each 28 day cycle (Window for Nab-paclitaxel is +/- 1 day) |
| Name | Type | Description |
|---|---|---|
| BYL-719 (alpelisib) | DRUG | Oral PI3K inhibitor |
| Nab-paclitaxel | DRUG | IV taxane |
Inclusion Criteria: 1. Ability to understand and the willingness to sign a written Informed Consent Form. 2. Age ≥ 18 years 3. Histologically proven HER-2 negative breast cancer (HER-2 negative defined as HER IHC 0 or 1+ and/or HER-2 FISH negative); HER-2 negative breast cancer includes hormone pos...
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BYL-719 is an investigational small molecule being studied for use in oncology, including advanced solid tumors with an alteration of the PIK3CA gene, estrogen receptor positive breast cancer, adenocarcinoma lung cancer, squamous cell lung carcinoma, breast cancer, and head and neck neoplasms. It is being developed by Novartis AG.
BYL-719 targets PIK3CA, a gene that encodes the p110 alpha catalytic subunit of phosphatidylinositol 3-kinase. It is being studied in patients whose tumors have an alteration of the PIK3CA gene, as well as in other advanced solid malignancies.
BYL-719 is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The drug is an investigational small molecule in clinical development for oncology indications.
BYL-719 is in clinical development, with trials conducted at Phase 1 and Phase 2 stages. The drug is investigational and has not been approved by regulatory authorities. Clinical trials have been completed across multiple studies, including Phase 1 and Phase 2 trials.
BYL-719 has been studied in several completed clinical trials, including NCT01219699, a Phase 1 study in patients with advanced solid malignancies whose tumors have a PIK3CA gene alteration; NCT01387321, a Phase 1 study in Japanese patients with advanced solid tumors; NCT02051751, a Phase 1 study combining BYL719 with paclitaxel in breast and head-and-neck cancer; and NCT02276027, a Phase 2 study in Chinese patients with non-small cell lung cancer.
Yes, BYL-719 and BYL719 refer to the same investigational drug. Both names are used interchangeably in clinical trial documentation and research literature to describe the small molecule being developed by Novartis AG for oncology indications.