Buparlisib

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Information
Drug Name
Buparlisib
Description
Entry(CIViC)
2
CIViC
Disease Mutation EL ET ED CS VO TR Pubmed Links
Solid Tumor PTEN DELETION
( ENST00000371953.8 ) PTEN DELETION
( ENST00000371953.8 ) 		B Predictive Does Not Support Sensitivity/Response Somatic 4 28281183 Detail
cancer PTEN DELETION
( ENST00000371953.8 ) PTEN DELETION
( ENST00000371953.8 ) 		B Predictive Supports Sensitivity/Response Somatic 3 25672916 Detail
Annotation
Description Associated Genes Associated Variants Sensitivity Supported Source Links
No objective responses were observed in the PTEN d... PTEN PTEN DELETION
( ENST00000371953.8 ) PTEN DELETION
( ENST00000371953.8 ) 		Sensitivity false CIViC Evidence detail
All three patients with PTEN loss had benefit from... PTEN PTEN DELETION
( ENST00000371953.8 ) PTEN DELETION
( ENST00000371953.8 ) 		Sensitivity true CIViC Evidence detail
NCT ID Status Phase Summary Start date Completion date
NCT02756247 Completed Phase 1 A Clinical Trial of Buparlisib and Ibrutinib in Lymphoma May 9, 2016 October 6, 2022
NCT01693614 Completed Phase 2 Safety and Efficacy of BKM120 in Relapsed and Refractory NHL February 28, 2013 July 21, 2017
NCT01719250 Completed Early Phase 1 Buparlisib in Treating Patients With Relapsed or Refractory Non-Hodgkin Lymphoma December 2012 March 22, 2017
NCT01923168 Completed Phase 2 Study of Letrozole With or Without BYL719 or Buparlisib, for the Neoadjuvant Treatment of Postmenopausal Women March 11, 2014 July 8, 2017
NCT01934361 Completed Phase 1 Phase Ib/II Study of Buparlisib Plus Carboplatin or Lomustine in Patients With Recurrent Glioblastoma Multiforme February 28, 2014 July 7, 2016
NCT02048787 Completed Phase 1 Pharmacokinetic Study of Buparlisib in Subjects With Renal Impairment. March 2014 March 2015
NCT02154776 Completed Phase 1 Dose Escalation Study of LEE011 in Combination With Buparlisib and Letrozole in HR+, HER2-negative Post-menopausal Women With Advanced Breast Cancer. June 27, 2014 October 26, 2016
NCT02340780 Completed Phase 2 Buparlisib in Patients With Relapsed and Refractory Chronic Lymphocytic Leukemia April 27, 2015 April 28, 2020
NCT01551030 Completed Phase 2 Buparlisib in Metastatic Transitional Cell Carcinoma of the Urothelium March 2012 September 2, 2020
NCT02303041 Terminated Phase 2 Pilot Study of Sonidegib and Buparlisib in Treating Patients With Advanced or Metastatic Basal Cell Carcinoma February 2015 June 2017
NCT02614508 Terminated Phase 1 Buparlisib and Ofatumumab or Ibrutinib in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia January 2016 August 2019
NCT01820325 Terminated Phase 1 Safety and Efficacy of Buparlisib (BKM120) in Patients With Untreated Squamous Non-small Cell Lung Cancer September 9, 2013 June 18, 2014
NCT01852292 Terminated Phase 2 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 October 1, 2013 March 30, 2017
NCT01870726 Terminated Phase 1/Phase 2 Safety and Efficacy of INC280 and Buparlisib (BKM120) in Patients With Recurrent Glioblastoma January 9, 2014 December 23, 2016
NCT01911325 Terminated Phase 1 Phase II Study of Buparlisib + Docetaxel in Advanced or Metastatic Squamous Non-small Cell Lung Cancer (NSCLC) Patients October 2013 August 2015
NCT02452294 Unknown status Phase 2 Buparlisib in Melanoma Patients Suffering From Brain Metastases (BUMPER) July 2015 July 2018
NCT01971489 Withdrawn Phase 1 Buparlisib, Gemcitabine Hydrochloride, and Cisplatin in Treating Patients With Advanced Solid Tumors September 2015