Drug · Small Molecule

Buparlisib

CI-DRUG-00000116Explore in graph →NCIt C90565 CHEMBL2017974 CIViC Phase 3

Regulatory

Approvals (0)

Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.

Data not yet available

No regulatory approval recorded. Absence here is not evidence of absence: only ingested jurisdictions are covered.

What CancerIndex knows

Curated evidence below
Sources

Derived

Development pipeline

Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.

Scope	Stage	Max phase	Phase 3	Trials	Jurisdictions	First approval	First trial
All cancers	Phase3	Phase 3	3	72	—	—	2008-11
Malignant Breast Neoplasm	Phase3	Phase 3	3	17	—	—	2008-11
Leukemia	Phase2	Phase 2	0	3	—	—	2012-07
Malignant Central Nervous System Neoplasm	Phase2	Phase 2	0	5	—

Curated evidence

Clinical evidence (5)

CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.

civicCuratedShowing 1–5 of 5 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

Therapy	Cancer	Type	Level	Direction · significance	Rating (1–5)	Status	Evidence	Source
PIK3CA Mutation1
Buparlisib	Glioblastoma

Clinical trials

Trials with this intervention (72)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 51–72 of 72 studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT01470209	A Phase I Study of BKM120 and Everolimus in Advanced Solid Malignancies	completed	Phase 1	43	Emory UniversityOTHER	1	Mar 19, 2018	clinicaltrials
NCT02194049	Cisplatin, Etoposide and PI3K Inhibitor BKM120 in Treating Patients With Advanced Solid Tumors or Small Cell Lung Cancer	completed	Phase 1

PIK3R1 Mutation1
Buparlisib	GlioblastomaCURATED_BROADER	Predictive	B	Does Not Support Sensitivity Response	3	submitted	EID7073 In this multicenter, open-label, multi-arm, phase 2 trial, 65 patients with PI3K pathway aberrations (defined by PTEN and pAKT IHC-Status in 95%, genomic testing in 5%) were treated with the PI3K inhi… (full text at CIViC) PMID 30715997 · Wen et al., 2019 · Open in CIViC	civic

PIK3R1 Mutation1

Buparlisib

GlioblastomaCURATED_BROADER

Predictive

Does Not Support Sensitivity Response

submitted

EID7073

In this multicenter, open-label, multi-arm, phase 2 trial, 65 patients with PI3K pathway aberrations (defined by PTEN and pAKT IHC-Status in 95%, genomic testing in 5%) were treated with the PI3K inhi… (full text at CIViC)

PMID 30715997 · Wen et al., 2019 · Open in CIViC

civic

PTEN Mutation1
Buparlisib	GlioblastomaCURATED_BROADER	Predictive	B	Does Not Support Sensitivity Response	3	submitted	EID7074 In this multicenter, open-label, multi-arm, phase 2 trial, 65 patients with PI3K pathway aberrations (defined by PTEN and pAKT IHC-Status in 95%, genomic testing in 5%) were treated with the PI3K inhi… (full text at CIViC) PMID 30715997 · Wen et al., 2019 · Open in CIViC	civic

PTEN Mutation1

Buparlisib

GlioblastomaCURATED_BROADER

Predictive

Does Not Support Sensitivity Response

submitted

EID7074

PMID 30715997 · Wen et al., 2019 · Open in CIViC

civic

PTEN Loss2
Buparlisib + Carboplatin + PaclitaxelCombination	Malignant NeoplasmALIAS	Predictive	C	Supports Sensitivity Response	3	accepted	EID714 All three patients with PTEN loss had benefit from adding Buparlisib to carboplatin+paclitaxel therapy in a phase I study in advanced solid cancers. PMID 25672916 · Hyman et al., 2015 · Open in CIViC	civic
〃	Solid NeoplasmCURATED_BROADER	Predictive	B	Does Not Support Sensitivity Response	2	accepted	EID5957 In one arm of this phase 1b study, 7 patients with PTEN deficient tumors were treated with continuous buparlisib (100 mg/daily) orally plus standard dose carboplatin AUC 5 and paclitaxel 175 mg/m2. No… (full text at CIViC) PMID 28281183 · Smyth et al., 2017 · Open in CIViC	civic

PTEN Loss2

Buparlisib + Carboplatin + PaclitaxelCombination

Malignant NeoplasmALIAS

Predictive

Supports Sensitivity Response

accepted

EID714

All three patients with PTEN loss had benefit from adding Buparlisib to carboplatin+paclitaxel therapy in a phase I study in advanced solid cancers.

PMID 25672916 · Hyman et al., 2015 · Open in CIViC

civic

〃

Solid NeoplasmCURATED_BROADER

Predictive

Does Not Support Sensitivity Response

accepted

EID5957

In one arm of this phase 1b study, 7 patients with PTEN deficient tumors were treated with continuous buparlisib (100 mg/daily) orally plus standard dose carboplatin AUC 5 and paclitaxel 175 mg/m2. No… (full text at CIViC)

PMID 28281183 · Smyth et al., 2017 · Open in CIViC

civic