PE20210121A1 - Regimenes de dosificacion superior de g1t38 - Google Patents

Regimenes de dosificacion superior de g1t38

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Publication number
PE20210121A1
PE20210121A1 PE2020000908A PE2020000908A PE20210121A1 PE 20210121 A1 PE20210121 A1 PE 20210121A1 PE 2020000908 A PE2020000908 A PE 2020000908A PE 2020000908 A PE2020000908 A PE 2020000908A PE 20210121 A1 PE20210121 A1 PE 20210121A1
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PE
Peru
Prior art keywords
provides
dosage regimen
solid
dose
auc
Prior art date
Application number
PE2020000908A
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English (en)
Inventor
Andrew Beelen
Jay Copeland Strum
Original Assignee
G1 Therapeutics Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
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Publication date
Application filed by G1 Therapeutics Inc filed Critical G1 Therapeutics Inc
Publication of PE20210121A1 publication Critical patent/PE20210121A1/es

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/506Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim not condensed and containing further heterocyclic rings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/517Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with carbocyclic ring systems, e.g. quinazoline, perimidine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/535Heterocyclic 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
    • A61K31/53751,4-Oxazines, e.g. morpholine
    • A61K31/53771,4-Oxazines, e.g. morpholine not condensed and containing further heterocyclic rings, e.g. timolol
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/565Compounds 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/04Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/08Peptides having 5 to 11 amino acids
    • A61K38/09Luteinising hormone-releasing hormone [LHRH], i.e. Gonadotropin-releasing hormone [GnRH]; Related peptides
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/06Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/505Medicinal preparations containing antigens or antibodies comprising antibodies

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Endocrinology (AREA)
  • Nutrition Science (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Reproductive Health (AREA)
  • Physiology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Nitrogen Condensed Heterocyclic Rings (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)

Abstract

La presente invencion se refiere a un regimen de dosificacion para la administracion del inhibidor selectivo de CDK4/6 conocido como G1T38, que es 2'-((5-(4-isopropilpiperazin-1-il)piridin-2-il)amino)-7',8'-dihidro-6'H-espiro[ciclohexano-1,9'-pirazino[1',2':1,5]pirrolo[2,3-d]pirimidin]-6'-ona o una sal farmaceuticamente aceptable del mismo y se emplea en el tratamiento de diversos tipos de cancer. Este regimen de dosificacion suministra: a) un regimen de dosificacion solido de G1T38 para el suministro oral que proporciona una relacion de (AUC(0-24ss) media en estado estacionario (h ng/mL))/dosis (mg) no mayor que 5 y/o b) un regimen de dosificacion solido de G1T38 para el suministro oral que en el dia 22 despues de la primera dosis proporciona una relacion AUC (0-24ss) media en estado estacionario (h ng/mL)/recuento absoluto de neutrofilos (celulas/mm3) no mayor que 1,25.
PE2020000908A 2018-01-08 2019-01-08 Regimenes de dosificacion superior de g1t38 PE20210121A1 (es)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US201862614952P 2018-01-08 2018-01-08
US201862679575P 2018-06-01 2018-06-01
US201962788017P 2019-01-03 2019-01-03
PCT/US2019/012720 WO2019136451A1 (en) 2018-01-08 2019-01-08 G1t38 superior dosage regimes

Publications (1)

Publication Number Publication Date
PE20210121A1 true PE20210121A1 (es) 2021-01-19

Family

ID=67143921

Family Applications (1)

Application Number Title Priority Date Filing Date
PE2020000908A PE20210121A1 (es) 2018-01-08 2019-01-08 Regimenes de dosificacion superior de g1t38

Country Status (15)

Country Link
US (2) US11357779B2 (es)
EP (1) EP3738084A4 (es)
JP (1) JP2021509680A (es)
KR (1) KR20200108867A (es)
CN (1) CN111837146A (es)
BR (1) BR112020013915A2 (es)
CA (1) CA3087570A1 (es)
CO (1) CO2020008825A2 (es)
IL (1) IL275708A (es)
MX (1) MX2020007312A (es)
PE (1) PE20210121A1 (es)
PH (1) PH12020551050A1 (es)
RU (1) RU2020123665A (es)
SG (1) SG11202005937QA (es)
WO (1) WO2019136451A1 (es)

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TW202128174A (zh) * 2019-10-09 2021-08-01 美商G1治療公司 失調之纖維母細胞生長因子受體訊息傳遞的癌症之標靶性治療
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Publication number Publication date
EP3738084A1 (en) 2020-11-18
RU2020123665A (ru) 2022-02-10
AU2019205821A1 (en) 2020-07-09
US11357779B2 (en) 2022-06-14
CO2020008825A2 (es) 2020-07-31
MX2020007312A (es) 2021-01-08
PH12020551050A1 (en) 2021-08-23
KR20200108867A (ko) 2020-09-21
SG11202005937QA (en) 2020-07-29
EP3738084A4 (en) 2021-11-17
WO2019136451A1 (en) 2019-07-11
IL275708A (en) 2020-08-31
US20200405721A1 (en) 2020-12-31
JP2021509680A (ja) 2021-04-01
BR112020013915A2 (pt) 2020-12-01
CA3087570A1 (en) 2019-07-11
CN111837146A (zh) 2020-10-27
US20230149406A1 (en) 2023-05-18

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