Therapy Detail
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| Therapy Name | Buparlisib + Paclitaxel |
| Synonyms | |
| Therapy Description | |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Buparlisib | BKM-120|BKM120 | PI3K Inhibitor (Pan) 42 | Buparlisib (BKM120) specifically inhibits class I PI3K in the PI3K/AKT kinase (or protein kinase B) signaling pathway in an ATP-competitive manner, and may result in apoptotic activity and inhibition of cell proliferation (PMID: 22188813). | |
| Paclitaxel | Taxol | 7-Epipaclitaxel | Antimicrotubule Agent 14 BCL2 Family Inhibitor 6 | Taxol (paclitaxel) binds to tubulin to inhibit microtubule disassembly, which results in decreased cell division, and also binds to the anti-apoptotic factor Bcl-2, promoting apoptosis (NCI Drug Dictionary). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| TP53 mutant | head and neck squamous cell carcinoma | predicted - sensitive | Buparlisib + Paclitaxel | Phase II | Actionable | In a Phase II (BERIL-1) trial, Buparlisib (BKM120) and Taxol (paclitaxel) combination treatment resulted in improved overall survival (HR=0.52) and prolonged progression-free survival (HR=0.45) in head and neck squamous cell carcinoma patients harboring TP53 mutations compared to TP53 wild-type patients (PMID: 29490986; NCT01852292). | 29490986 |
| PIK3CA H1047R | breast metaplastic carcinoma | predicted - sensitive | Buparlisib + Paclitaxel | Case Reports/Case Series | Actionable | In a clinical case study, Buparlisib (BKM120) in combination with Taxol (paclitaxel) resulted in a durable partial response in a patient with breast metaplastic carcinoma harboring PIK3CA H1047R, with a total response period of 70 weeks and an overall survival of 42 months (PMID: 30577988). | 30577988 |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT01852292 | Phase II | Buparlisib + Paclitaxel | Study of Efficacy and Safety of Buparlisib (BKM120) Plus Paclitaxel Versus Placebo Plus Paclitaxel in Recurrent or Metastatic Head and Neck Cancer Previously Pre-treated With a Platinum Therapy | Terminated | USA | POL | ITA | IRL | HUN | GBR | FRA | ESP | DEU | CHE | CAN | AUS | 6 |
| NCT01572727 | Phase II | Buparlisib + Paclitaxel Paclitaxel | A Study of the Experimental Drug BKM120 With Paclitaxel in Patients With HER2 Negative, Locally Advanced or Metastatic Breast Cancer, With or Without PI3K Activation | Completed | USA | NLD | ITA | ISR | HUN | GBR | FRA | ESP | DEU | CAN | BRA | BEL | AUT | AUS | 8 |
| NCT04338399 | Phase III | Buparlisib + Paclitaxel Paclitaxel | The BURAN Study of Buparlisib in Patients With Recurrent or Metastatic HNSCC (BURAN) | Active, not recruiting | USA | POL | ITA | HUN | GBR | FRA | ESP | DEU | CAN | BEL | AUS | ARG | 5 |
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