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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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)
  • Investigating Or Analysing Biological Materials (AREA)
  • Measuring Or Testing Involving Enzymes Or Micro-Organisms (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 (cg-RX-API-DMAC7.html)
EP (1) EP3383391A1 (cg-RX-API-DMAC7.html)
JP (1) JP2018535997A (cg-RX-API-DMAC7.html)
KR (1) KR20180084830A (cg-RX-API-DMAC7.html)
CN (1) CN108366998A (cg-RX-API-DMAC7.html)
AU (1) AU2016362683B2 (cg-RX-API-DMAC7.html)
CA (1) CA3006419A1 (cg-RX-API-DMAC7.html)
HK (1) HK1253737A1 (cg-RX-API-DMAC7.html)
IL (1) IL259716A (cg-RX-API-DMAC7.html)
MX (1) MX2018006777A (cg-RX-API-DMAC7.html)
RU (1) RU2018123524A (cg-RX-API-DMAC7.html)
TW (1) TW201722429A (cg-RX-API-DMAC7.html)
WO (1) WO2017093905A1 (cg-RX-API-DMAC7.html)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20210355545A1 (en) * 2018-10-15 2021-11-18 The Johns Hopkins University Methods and materials for assessing and treating cancer

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
EP1641809B2 (en) 2003-07-05 2018-10-03 The Johns Hopkins University Method and compositions for detection and enumeration of genetic variations
PT3296407T (pt) 2004-03-02 2019-08-23 Univ Johns Hopkins Mutações do gene pik3ca em cancros 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
JP5658565B2 (ja) 2007-09-12 2015-01-28 ジェネンテック， インコーポレイテッド ホスホイノシチド３−キナーゼ阻害剤化合物と化学療法剤との組合せ、および使用方法
CN101909631B (zh) 2007-10-25 2012-09-12 健泰科生物技术公司 制备噻吩并嘧啶化合物的方法
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
WO2017093905A1 (en) 2017-06-08
CA3006419A1 (en) 2017-06-08
IL259716A (en) 2018-07-31
AU2016362683A1 (en) 2018-05-31
TW201722429A (zh) 2017-07-01
EP3383391A1 (en) 2018-10-10
US20200138824A1 (en) 2020-05-07
HK1253737A1 (zh) 2019-06-28
RU2018123524A (ru) 2020-01-09
MX2018006777A (es) 2018-08-01
CN108366998A (zh) 2018-08-03
US20180353515A1 (en) 2018-12-13
KR20180084830A (ko) 2018-07-25
JP2018535997A (ja) 2018-12-06
RU2018123524A3 (cg-RX-API-DMAC7.html) 2020-04-02

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