AU2016362683B2 - Treatment of cancer with a PI3K inhibitor in a patient preselected for having a PIK3CA mutation in the ctDNA - Google Patents

Treatment of cancer with a PI3K inhibitor in a patient preselected for having a PIK3CA mutation in the ctDNA Download PDF

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Publication number
AU2016362683B2
AU2016362683B2 AU2016362683A AU2016362683A AU2016362683B2 AU 2016362683 B2 AU2016362683 B2 AU 2016362683B2 AU 2016362683 A AU2016362683 A AU 2016362683A AU 2016362683 A AU2016362683 A AU 2016362683A AU 2016362683 B2 AU2016362683 B2 AU 2016362683B2
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Prior art keywords
cancer
patient
ctdna
amide
pik3ca
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Ceased
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AU2016362683A
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AU2016362683A1 (en
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Emmanuelle DI TOMASO
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Novartis AG
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Novartis AG
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/535—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines
    • A61K31/5375—1,4-Oxazines, e.g. morpholine
    • A61K31/5377—1,4-Oxazines, e.g. morpholine not condensed and containing further heterocyclic rings, e.g. timolol
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4427—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
    • A61K31/4439—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/565—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N15/00—Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
    • C12N15/09—Recombinant DNA-technology
    • C12N15/11—DNA or RNA fragments; Modified forms thereof; Non-coding nucleic acids having a biological activity
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/68—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving nucleic acids
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/68—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving nucleic acids
    • C12Q1/6876—Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes
    • C12Q1/6883—Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes for diseases caused by alterations of genetic material
    • C12Q1/6886—Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes for diseases caused by alterations of genetic material for cancer
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q2600/00—Oligonucleotides characterized by their use
    • C12Q2600/106—Pharmacogenomics, i.e. genetic variability in individual responses to drugs and drug metabolism
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q2600/00—Oligonucleotides characterized by their use
    • C12Q2600/156—Polymorphic or mutational markers

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Genetics & Genomics (AREA)
  • General Health & Medical Sciences (AREA)
  • Zoology (AREA)
  • Wood Science & Technology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • General Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biotechnology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Analytical Chemistry (AREA)
  • Immunology (AREA)
  • Biochemistry (AREA)
  • Microbiology (AREA)
  • Biophysics (AREA)
  • Physics & Mathematics (AREA)
  • Biomedical Technology (AREA)
  • Epidemiology (AREA)
  • Pathology (AREA)
  • Oncology (AREA)
  • Hospice & Palliative Care (AREA)
  • Plant Pathology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
AU2016362683A 2015-12-03 2016-11-30 Treatment of cancer with a PI3K inhibitor in a patient preselected for having a PIK3CA mutation in the ctDNA Ceased AU2016362683B2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201562262620P 2015-12-03 2015-12-03
US62/262,620 2015-12-03
PCT/IB2016/057208 WO2017093905A1 (en) 2015-12-03 2016-11-30 Treatment of cancer with a pi3k inhibitor in a patient preselected for having a pik3ca mutation in the ctdna

Publications (2)

Publication Number Publication Date
AU2016362683A1 AU2016362683A1 (en) 2018-05-31
AU2016362683B2 true AU2016362683B2 (en) 2019-11-07

Family

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Family Applications (1)

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AU2016362683A Ceased AU2016362683B2 (en) 2015-12-03 2016-11-30 Treatment of cancer with a PI3K inhibitor in a patient preselected for having a PIK3CA mutation in the ctDNA

Country Status (13)

Country Link
US (2) US20180353515A1 (enExample)
EP (1) EP3383391A1 (enExample)
JP (1) JP2018535997A (enExample)
KR (1) KR20180084830A (enExample)
CN (1) CN108366998A (enExample)
AU (1) AU2016362683B2 (enExample)
CA (1) CA3006419A1 (enExample)
HK (1) HK1253737A1 (enExample)
IL (1) IL259716A (enExample)
MX (1) MX2018006777A (enExample)
RU (1) RU2018123524A (enExample)
TW (1) TW201722429A (enExample)
WO (1) WO2017093905A1 (enExample)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2020081549A1 (en) * 2018-10-15 2020-04-23 The Regents Of The University Of California Methods and materials for assessing and treating cancer
CN116240287A (zh) * 2023-01-17 2023-06-09 普洱市人民医院 基于循环肿瘤dna的乳腺癌标志物及其应用

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2013144249A1 (en) * 2012-03-29 2013-10-03 Novartis Ag Pharmaceutical diagnostic
WO2015172085A2 (en) * 2014-05-09 2015-11-12 Memorial Sloan-Kettering Cancer Center Biomarkers for response to pi3k inhibitors

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8048627B2 (en) 2003-07-05 2011-11-01 The Johns Hopkins University Method and compositions for detection and enumeration of genetic variations
ES2537633T3 (es) 2004-03-02 2015-06-10 The Johns Hopkins University Mutaciones del gen de PIK3CA en cánceres humanos
GB0510390D0 (en) 2005-05-20 2005-06-29 Novartis Ag Organic compounds
JO2660B1 (en) 2006-01-20 2012-06-17 نوفارتيس ايه جي Pi-3 inhibitors and methods of use
BRPI0816769A2 (pt) 2007-09-12 2016-11-29 Hoffmann La Roche combinações de compostos inibidores de fosfoinositida 3-cinase e agentes quimioterapêuticos, e métodos de uso
WO2009055730A1 (en) 2007-10-25 2009-04-30 Genentech, Inc. Process for making thienopyrimidine compounds
UA104147C2 (uk) 2008-09-10 2014-01-10 Новартис Аг Похідна піролідиндикарбонової кислоти та її застосування у лікуванні проліферативних захворювань
US20130317037A1 (en) * 2010-11-16 2013-11-28 Glaxosmithkline Intellectual Property Development Limited Method of administration and treatment

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2013144249A1 (en) * 2012-03-29 2013-10-03 Novartis Ag Pharmaceutical diagnostic
WO2015172085A2 (en) * 2014-05-09 2015-11-12 Memorial Sloan-Kettering Cancer Center Biomarkers for response to pi3k inhibitors

Non-Patent Citations (6)

* Cited by examiner, † Cited by third party
Title
C. FRITSCH ET AL, "Characterization of the Novel and Specific PI3K Inhibitor NVP-BYL719 and Development of the Patient Stratification Strategy for Clinical Trials", MOLECULAR CANCER THERAPEUTICS, (2014), vol. 13, no. 5, pages 1117 - 1129 *
CHIYA OSHIRO ET AL, "PIK3CA mutations in serum DNA are predictive of recurrence in primary breast cancer patients", BREAST CANCER RESEARCH AND TREATMENT., US, (2015-03-04), vol. 150, no. 2, p 299 - 307 *
CRISTIAN MASSACESI ET AL, "Overcoming Phosphatidylinositol 3-Kinase (PI3K) Activation in Breast Cancer: Emerging PI3K Inhibitors", THE JOURNAL OF ONCOPATHOLOGY, (2015-02-01), vol. 3, no. 1, p 27 - 39 *
Dejan Juric ET AL, "Abstract CT-01: BYL719, a next generation PI3K alpha specific inhibitor: Preliminary safety, PK, and efficacy results from the first-in-human study", Cancer Research AACR 103rd Annual Meeting Abstracts, (2012), p1-3 *
JOHAN F. VANSTEENKISTE ET AL, "Safety and Efficacy of Buparlisib (BKM120) in Patients with PI3K Pathway-Activated Non-Small Cell Lung Cancer", JOURNAL OF THORACIC ONCOLOGY (2015)v10p1319 - 1327 *
Payal D. Shah ET AL, "Abstract PD5-3: Phase I trial: PI3K[alpha] inhibitor BYL719 plus aromatase inhibitor (AI) for patients with hormone receptor-positive (HR+) metastatic breast cancer (MBC)", Cancer Research, (2015-05-01), pages 1 - 4, *

Also Published As

Publication number Publication date
RU2018123524A3 (enExample) 2020-04-02
HK1253737A1 (zh) 2019-06-28
TW201722429A (zh) 2017-07-01
MX2018006777A (es) 2018-08-01
US20200138824A1 (en) 2020-05-07
US20180353515A1 (en) 2018-12-13
KR20180084830A (ko) 2018-07-25
RU2018123524A (ru) 2020-01-09
CN108366998A (zh) 2018-08-03
WO2017093905A1 (en) 2017-06-08
CA3006419A1 (en) 2017-06-08
AU2016362683A1 (en) 2018-05-31
IL259716A (en) 2018-07-31
EP3383391A1 (en) 2018-10-10
JP2018535997A (ja) 2018-12-06

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