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The DOI matches its Crossref record; 9 of the 9 references it cites were found in a registry or an index.

Phase I, Dose-Escalation Study of BKM120, an Oral Pan-Class I PI3K Inhibitor, in Patients With Advanced Solid Tumors

Open access
Bendell, Johanna C., Rodon, Jordi, Burris, Howard A., de Jonge, Maja, Verweij, Jaap, Birle, Diana, Demanse, David, De Buck, Stefan S., Ru, Qinhua C., Peters, Malte, Goldbrunner, Michael, Baselga, José·2012·Journal of Clinical Oncology

Abstract

Purpose: This phase I dose-escalation study investigated the maximum-tolerated dose (MTD), safety, preliminary activity, pharmacokinetics (PK), and pharmacodynamics of BKM120, a potent and highly specific oral pan-Class I PI3K inhibitor. Patients and Methods: Thirty-five patients with advanced solid tumors received daily BKM120 12.5 to 150 mg. Dose escalation was guided by a Bayesian logistic regression model with overdose control. Assessments included archival tumor molecular status, response by Response Evaluation Criteria in Solid Tumors (RECIST), positron emission tomography tracer uptake ([18 F]fluorodeoxyglucose positron emission tomography [FDG-PET]), fasting plasma C-peptide, and phosphorylated ribosomal protein S6 (pS6) in skin biopsies. Results: Overall, treatment was well tolerated. Dose-limiting toxicities were grade 2 mood alteration (80 mg), grade 3 epigastralgia, grade 3 rash, grade 2 and grade 3 mood alteration (100 mg), and two grade 4 hyperglycemia (150 mg). The MTD was 100 mg/d. Frequent treatment-related adverse events included rash, hyperglycemia, diarrhea, anorexia, and mood alteration (37% each); nausea (31%); fatigue (26%); pruritus (23%); and mucositis (23%). BKM120 demonstrated rapid absorption, half-life of ∼40 hours, ∼three-fold steady-state accumulation, dose-proportional exposure, and moderate interpatient variability. One patient demonstrated a confirmed partial response (triple-negative breast cancer); seven patients (20%) were on study for ≥ 8 months. BKM120 demonstrated dose-dependent pharmacodynamic effects on [18 F]FDG-PET, fasting C-peptide, fasting blood glucose, and pS6. No significant trends were seen to correlate tumor molecular alterations with clinical activity. Conclusion: This study demonstrates feasibility and proof-of-concept of class I PI3K inhibition in patients with advanced cancers. BKM120, at the MTD of 100 mg/d, is safe and well tolerated, with a favorable PK profile, clear evidence of target inhibition, and preliminary antitumor activity.

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Metadata

Authors
Bendell, J. C., Rodon, J., Burris, H. A., de Jonge, M., Verweij, J., Birle, D., Demanse, D., De Buck, S. S., Ru, Q. C., Peters, M., Goldbrunner, M., & Baselga, J.
Venue
Journal of Clinical Oncology
Published
2012-01-20
Volume
30
Issue
3
Pages
282-290
ISSN
  • 0732-183X (ISSN-L)
  • 1527-7755
OpenAlex
W2165404212
Cited by
684
References
9
FWCI
25.04
Type
journal article
Language
en
Open access
bronze

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CoChat. (2026). Citation check: Phase I, Dose-Escalation Study of BKM120, an Oral Pan-Class I PI3K Inhibitor, in Patients With Advanced Solid Tumors. https://app.cochat.ai/papers/10.1200/jco.2011.36.1360
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Bendell, J. C., Rodon, J., Burris, H. A., de Jonge, M., Verweij, J., Birle, D., Demanse, D., De Buck, S. S., Ru, Q. C., Peters, M., Goldbrunner, M., & Baselga, J. (2012). Phase I, Dose-Escalation Study of BKM120, an Oral Pan-Class I PI3K Inhibitor, in Patients With Advanced Solid Tumors. Journal of Clinical Oncology. https://doi.org/10.1200/jco.2011.36.1360

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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

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