Clinical benefit rate for patients with solid tumors will be assessed using RECIST 1.1 and will include responses of Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) at \>=16 weeks. For hematologic tumors other appropriate hematological response criteria was applied. Response criteria: CR=Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm., PR=At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters, SD=Neither sufficient shri
Group
Value
95% CI
BKM120
15.1
9.7 – 21.9
Overall Response of Partial Response (PR) or Greater. PR=at Least a 30% Decrease in the Sum of Diameters of Target Lesions, Taking as Reference the Baseline Sum DiametersSecondary· baseline and every 8 weeks until disease progression or end of treatment, assessed up to 24 months
Overall Response (OR) of Partial Response (PR) or greater is based on local investigator assessment. For patients with solid tumors, the assessment criteria will be RECIST 1.1 and will include responses of CR and/or PR. For hematologic tumors other appropriate hematological response criteria apply
Group
Value
95% CI
BKM120
1.4
0.2 – 4.9
Progression-Free Survival - Number of Participants With an EventSecondary· Every 8 Weeks until death, assessed up to 24 months
Progression free survival (PFS) is defined as the time from the date of first dose to the date of first documented disease progression or relapse or death due to any cause
participants with an event
Group
Value
95% CI
BKM120
112
participants censored
Group
Value
95% CI
BKM120
34
Progression-Free Survival (PFS)- Kaplan-Meier Estimates of PFS Timing in MonthsSecondary· baseline up to 24 months
Progression free survival (PFS) is defined as the time from the date of first dose to the date of first documented disease progression or relapse or death due to any cause
Group
Value
95% CI
BKM120
1.9
1.8 – 2.34
Progression-Free Survival (PFS)- Kaplan-Meier Estimates of PFS Rate in PercentagesSecondary· baseline up to 24 months
Progression free survival (PFS) is defined as the time from the date of first dose to the date of first documented disease progression or relapse or death due to any cause.
1 month
Group
Value
95% CI
BKM120
88.4
81.5 – 92.9
2 months
Group
Value
95% CI
BKM120
43.8
34.9 – 52.3
3 months
Group
Value
95% CI
BKM120
39.4
30.7 – 47.9
4 months
Group
Value
95% CI
BKM120
20.4
13.5 – 28.3
5 months
Group
Value
95% CI
BKM120
20.4
13.5 – 28.3
6 months
Group
Value
95% CI
BKM120
14.1
8.2 – 21.5
9 months
Group
Value
95% CI
BKM120
5.8
2.1 – 12.1
12 months
Group
Value
95% CI
BKM120
2.9
0.6 – 8.6
Overall Survival - Number of Participants With an EventSecondary· Every 8 Weeks until death, assessed up to 24 months
Overall survival (OS) is defined as the time from the date of first dose to the date of death due to any cause. If a patient is not known to have died, survival time will be censored at the date of the last contact
participants with an event
Group
Value
95% CI
BKM120
110
participants censored
Group
Value
95% CI
BKM120
36
Overall Survival (OS)- Kaplan-Meier Estimates of OS Timing in MonthsSecondary· baseline up to 24 months
Overall survival (OS) is defined as the time from the date of first dose to the date of death due to any cause. If a patient is not known to have died, survival time will be censored at the date of the last contact
Group
Value
95% CI
BKM120
6.3
5.2 – 8.8
Overall Survival (OS)- Kaplan-Meier Estimates of OS Rate in PercentagesSecondary· baseline up to 30 months
Overall survival (OS) is defined as the time from the date of first dose to the date of death due to any cause. If a patient is not known to have died, survival time will be censored at the date of the last contact
1 month
Group
Value
95% CI
BKM120
97.3
92.8 – 99.0
2 months
Group
Value
95% CI
BKM120
83.4
76.2 – 88.5
3 months
Group
Value
95% CI
BKM120
73.5
65.5 – 80.0
4 months
Group
Value
95% CI
BKM120
61.5
53.0 – 68.9
5 months
Group
Value
95% CI
BKM120
60.1
51.6 – 67.6
6 months
Group
Value
95% CI
BKM120
51.5
43.0 – 59.4
9 months
Group
Value
95% CI
BKM120
41.3
33.2 – 49.3
12 months
Group
Value
95% CI
BKM120
30.2
22.6 – 38.1
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The purpose of this signal seeking study was is to determine whether treatment with BKM120 demonstrates sufficient efficacy in select pathway-activated solid tumors and/or hematologic malignancies to warrant further study.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT02220855 — A Study of BKM120 (Buparlisib) in Relapsed or Refractory Thymomas
· Phase 2
· completed
NCT02113878 — Phase Ib Study of BKM120 With Cisplatin and XRT in High Risk Locally Advanced Squamous Cell Cancer of Head and Neck
· Phase 1
· completed
NCT02159066 — LGX818 and MEK162 in Combination With a Third Agent (BKM120, LEE011, BGJ398 or INC280) in Advanced BRAF Melanoma
· Phase 2
· completed
NCT02000882 — STAR Cape+BKM120 MBC With Brain Met
· Phase 2
· completed
NCT02088684 — Study of LEE011 With Fulvestrant and BYL719 or BKM120 in Advanced Breast Cancer
· Phase 1
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
Last refreshed: 19 October 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01833169.