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) 40 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
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
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

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT04338399 Phase III Buparlisib + Paclitaxel Paclitaxel The BURAN Study of Buparlisib in Patients With Recurrent or Metastatic HNSCC (BURAN) Active, not recruiting USA | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUS 8
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 | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS 11
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 | ITA | GBR | FRA | ESP | DEU | CAN | AUS 10


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