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 1–50 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
NCT01339052	Phase II Study of BKM120 for Subjects With Recurrent Glioblastoma	completed	Phase 2	65	L. Nicolas Gonzalez Castro, MD, PhDOTHER	1	Jul 27, 2026	clinicaltrials
NCT04975958	Double/Triple Combinations of AN2025, AN0025 and Atezolizumab in Advanced Solid Tumors	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