AU2015215000B2 - Solid pharmaceutical compositions of androgen receptor antagonists - Google Patents

Solid pharmaceutical compositions of androgen receptor antagonists Download PDF

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Publication number
AU2015215000B2
AU2015215000B2 AU2015215000A AU2015215000A AU2015215000B2 AU 2015215000 B2 AU2015215000 B2 AU 2015215000B2 AU 2015215000 A AU2015215000 A AU 2015215000A AU 2015215000 A AU2015215000 A AU 2015215000A AU 2015215000 B2 AU2015215000 B2 AU 2015215000B2
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AU
Australia
Prior art keywords
compound
formula
pharmaceutical composition
solid
solid pharmaceutical
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
AU2015215000A
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English (en)
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AU2015215000A1 (en
Inventor
Petra BOZIC
Petra DRAKSLER
Rok Grahek
Andrija LEBAR
Klemen Naversnik
Jerneja Opara
Bostjan PETEK
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Lek Pharmaceuticals dd
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Lek Pharmaceuticals dd
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Publication date
Application filed by Lek Pharmaceuticals dd filed Critical Lek Pharmaceuticals dd
Publication of AU2015215000A1 publication Critical patent/AU2015215000A1/en
Application granted granted Critical
Publication of AU2015215000B2 publication Critical patent/AU2015215000B2/en
Ceased legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/415—1,2-Diazoles
    • A61K31/4152—1,2-Diazoles having oxo groups directly attached to the heterocyclic ring, e.g. antipyrine, phenylbutazone, sulfinpyrazone
    • 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
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/4164—1,3-Diazoles
    • 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
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/4164—1,3-Diazoles
    • A61K31/4166—1,3-Diazoles having oxo groups directly attached to the heterocyclic ring, e.g. phenytoin
    • 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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/10—Dispersions; Emulsions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/143—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1611—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1641—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2009—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4816—Wall or shell material
    • A61K9/4825—Proteins, e.g. gelatin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/485—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/08—Drugs for disorders of the urinary system of the prostate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Inorganic Chemistry (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Urology & Nephrology (AREA)
  • Dispersion Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
AU2015215000A 2014-02-05 2015-02-04 Solid pharmaceutical compositions of androgen receptor antagonists Ceased AU2015215000B2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP14154047.6 2014-02-05
EP14154047 2014-02-05
PCT/EP2015/052311 WO2015118015A1 (en) 2014-02-05 2015-02-04 Solid pharmaceutical compositions of androgen receptor antagonists

Publications (2)

Publication Number Publication Date
AU2015215000A1 AU2015215000A1 (en) 2016-09-15
AU2015215000B2 true AU2015215000B2 (en) 2017-10-19

Family

ID=50031275

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2015215000A Ceased AU2015215000B2 (en) 2014-02-05 2015-02-04 Solid pharmaceutical compositions of androgen receptor antagonists

Country Status (10)

Country Link
US (2) US20160346207A1 (cg-RX-API-DMAC7.html)
EP (1) EP3102183A1 (cg-RX-API-DMAC7.html)
JP (2) JP6666254B2 (cg-RX-API-DMAC7.html)
KR (2) KR20160113294A (cg-RX-API-DMAC7.html)
CN (2) CN112402360A (cg-RX-API-DMAC7.html)
AU (1) AU2015215000B2 (cg-RX-API-DMAC7.html)
CA (1) CA2940984A1 (cg-RX-API-DMAC7.html)
EA (2) EA037895B1 (cg-RX-API-DMAC7.html)
MX (1) MX386859B (cg-RX-API-DMAC7.html)
WO (1) WO2015118015A1 (cg-RX-API-DMAC7.html)

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LT3305285T (lt) 2012-09-26 2020-12-10 Aragon Pharmaceuticals, Inc. Anti-androgenai, skirti gydyti nametastazavusį kastracijai atsparų prostatos vėžį
PL3226843T3 (pl) * 2014-12-05 2021-12-13 Aragon Pharmaceuticals, Inc. Kompozycje przeciwnowotworowe
CN114886852A (zh) 2014-12-05 2022-08-12 阿拉贡药品公司 抗癌组合物
CA2969661C (en) * 2014-12-05 2023-04-25 Aragon Pharmaceuticals, Inc. Anticancer compositions
MX2018014846A (es) * 2016-06-03 2019-03-14 Aragon Pharmaceuticals Inc Composiciones antineoplasicas.
WO2017221144A1 (en) * 2016-06-20 2017-12-28 Dr. Reddy's Laboratories Limited Process for the preparation of elagolix sodium and its polymorph
CN110023297A (zh) * 2016-07-08 2019-07-16 詹森药业有限公司 作为雄性激素受体拮抗剂的取代的乙内酰脲和硫代己内酰脲衍生物
EP3500310A1 (en) 2016-08-20 2019-06-26 FTF Pharma Private Limited Pharmaceutical composition comprising an androgen receptor inhibitor
KR102684756B1 (ko) * 2017-04-28 2024-07-15 아스텔라스세이야쿠 가부시키가이샤 엔잘루타미드를 함유하는 경구 투여용 의약 조성물
WO2019008426A1 (en) * 2017-07-04 2019-01-10 Bdr Pharmaceuticals International Private Limited NOVEL ENZALUTAMIDE ORAL GALENIC FORM COMPOSITION AND METHOD OF MANUFACTURING THE SAME
WO2019016747A1 (en) * 2017-07-20 2019-01-24 Dr. Reddy's Laboratories Limited AMORPHOUS SOLID DISPERSIONS OF APALUTAMIDE AND PROCESS FOR THEIR PREPARATION
RU2020109948A (ru) * 2017-08-08 2021-09-10 Др. Редди'З Лабораториз Лимитед Экструдированные композиции энзалутамида
CZ2018234A3 (cs) 2018-05-21 2019-12-04 Zentiva Ks Zvýšení rozpustnosti a biodostupnosti enzalutamidu
CN108815129A (zh) * 2018-07-12 2018-11-16 天津双硕医药科技有限公司 一种恩杂鲁胺纳米晶体口服固体药物组合物
ES2943492T3 (es) 2018-11-30 2023-06-13 Chemocentryx Inc Formulación de cápsulas
JP2022533463A (ja) * 2019-05-23 2022-07-22 ヘルム・アクチエンゲゼルシャフト エンザルタミドを含むナノ粒子
EP4037659B1 (en) 2019-10-03 2025-11-19 Synthon BV Pharmaceutical composition comprising enzalutamide
EP3811932A1 (en) 2019-10-22 2021-04-28 Zentiva K.S. Dosage form of apalutamide
US20240207239A1 (en) * 2021-02-06 2024-06-27 Sunshine Lake Pharma Co., Ltd. Composition and preparation method therefor
WO2024127361A1 (en) 2022-12-16 2024-06-20 Ferring B.V. Enzalutamide nanocrystals, methods and compositions
WO2025052925A1 (ja) * 2023-09-08 2025-03-13 沢井製薬株式会社 エンザルタミド固体分散体及びその製造方法、並びにエンザルタミド含有製剤及びその製造方法
WO2025125565A1 (en) 2023-12-13 2025-06-19 Krka, D.D., Novo Mesto Tablet comprising enzalutamide

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WO2007127010A2 (en) * 2006-03-29 2007-11-08 The Regents Of The University Of California Diarylthiohydantoin compounds
WO2011103202A2 (en) * 2010-02-16 2011-08-25 Aragon Pharmaceuticals, Inc. Androgen receptor modulators and uses thereof
WO2014043208A1 (en) * 2012-09-11 2014-03-20 Medivation Prostate Therapeutics, Inc. Formulations of enzalutamide

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CA2448825C (en) * 2001-06-22 2009-08-11 Pfizer Products Inc. Pharmaceutical compositions of adsorbates of amorphous drug
EP2877599B1 (en) * 2012-07-27 2019-10-23 Aragon Pharmaceuticals, Inc. Methods and compositions for determining resistance to androgen receptor therapy

Patent Citations (3)

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WO2007127010A2 (en) * 2006-03-29 2007-11-08 The Regents Of The University Of California Diarylthiohydantoin compounds
WO2011103202A2 (en) * 2010-02-16 2011-08-25 Aragon Pharmaceuticals, Inc. Androgen receptor modulators and uses thereof
WO2014043208A1 (en) * 2012-09-11 2014-03-20 Medivation Prostate Therapeutics, Inc. Formulations of enzalutamide

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Title
BAJAJ, H. et al. "Bioavailability Enhancement: A review" International Journal of Pharma and Bio Sciences (2011) Vol.2 No.2, pages 202 to 216 *
BAUER, K.H. et al. "Lehrbuch der Pharmazeutischen Technologie" Wissenschaftliche Verlagsgesellschaft mbH, 1999, ISBN 3-8047-1700-4, Vol.6 pages 210 to 211 *
RATHKOPF, D.E. et al. "Phase I Study of ARN-509, a Novel Antiandrogen, in the Treatment of Castration-Resistant Prostate Cancer" Journal of Clinical Oncology (2013) Vol.31 No.28, pages 3525 to 3530 *

Also Published As

Publication number Publication date
EA201691568A1 (ru) 2017-01-30
EA201891397A1 (ru) 2019-03-29
MX2016010216A (es) 2016-11-15
KR20200015830A (ko) 2020-02-12
JP2017507928A (ja) 2017-03-23
CN112402360A (zh) 2021-02-26
AU2015215000A1 (en) 2016-09-15
JP6666254B2 (ja) 2020-03-13
CA2940984A1 (en) 2015-08-13
US20160346207A1 (en) 2016-12-01
JP6934932B2 (ja) 2021-09-15
MX386859B (es) 2025-03-19
CN106102716A (zh) 2016-11-09
JP2020090505A (ja) 2020-06-11
EP3102183A1 (en) 2016-12-14
WO2015118015A1 (en) 2015-08-13
US20200163882A1 (en) 2020-05-28
EA037895B1 (ru) 2021-06-02
KR20160113294A (ko) 2016-09-28

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