JP2017511313A5 - - Google Patents
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- Publication number
- JP2017511313A5 JP2017511313A5 JP2016558714A JP2016558714A JP2017511313A5 JP 2017511313 A5 JP2017511313 A5 JP 2017511313A5 JP 2016558714 A JP2016558714 A JP 2016558714A JP 2016558714 A JP2016558714 A JP 2016558714A JP 2017511313 A5 JP2017511313 A5 JP 2017511313A5
- Authority
- JP
- Japan
- Prior art keywords
- pharmaceutical composition
- cancer
- composition according
- braf
- patient
- 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.)
- Granted
Links
- 239000008194 pharmaceutical composition Substances 0.000 claims description 62
- 206010028980 Neoplasm Diseases 0.000 claims description 31
- 201000011510 cancer Diseases 0.000 claims description 28
- 230000035772 mutation Effects 0.000 claims description 23
- 238000000034 method Methods 0.000 claims description 22
- 102100027103 Serine/threonine-protein kinase B-raf Human genes 0.000 claims description 19
- 239000007962 solid dispersion Substances 0.000 claims description 17
- -1 1- (6-Amino-5-chloropyrimidine-4-carboxamido) ethyl Chemical group 0.000 claims description 15
- 102100039788 GTPase NRas Human genes 0.000 claims description 14
- 101000744505 Homo sapiens GTPase NRas Proteins 0.000 claims description 14
- 101000984753 Homo sapiens Serine/threonine-protein kinase B-raf Proteins 0.000 claims description 13
- 229920001577 copolymer Polymers 0.000 claims description 13
- 239000000523 sample Substances 0.000 claims description 12
- 239000000203 mixture Substances 0.000 claims description 9
- 239000000546 pharmaceutical excipient Substances 0.000 claims description 9
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims description 8
- 150000003839 salts Chemical class 0.000 claims description 8
- GGNIKGLUPSHSBV-UHFFFAOYSA-N thiazole-5-carboxamide Chemical compound NC(=O)C1=CN=CS1 GGNIKGLUPSHSBV-UHFFFAOYSA-N 0.000 claims description 7
- 101150073096 NRAS gene Proteins 0.000 claims description 6
- 101150048834 braF gene Proteins 0.000 claims description 6
- 210000004881 tumor cell Anatomy 0.000 claims description 5
- 229920002785 Croscarmellose sodium Polymers 0.000 claims description 4
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims description 4
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims description 4
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 claims description 4
- 229940075614 colloidal silicon dioxide Drugs 0.000 claims description 4
- 229920001531 copovidone Polymers 0.000 claims description 4
- 229960001681 croscarmellose sodium Drugs 0.000 claims description 4
- 235000010947 crosslinked sodium carboxy methyl cellulose Nutrition 0.000 claims description 4
- 235000019359 magnesium stearate Nutrition 0.000 claims description 4
- 238000004519 manufacturing process Methods 0.000 claims description 4
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims description 4
- 239000008108 microcrystalline cellulose Substances 0.000 claims description 4
- 229940016286 microcrystalline cellulose Drugs 0.000 claims description 4
- 108020004707 nucleic acids Proteins 0.000 claims description 4
- 150000007523 nucleic acids Chemical class 0.000 claims description 4
- 102000039446 nucleic acids Human genes 0.000 claims description 4
- 230000000144 pharmacologic effect Effects 0.000 claims description 4
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims description 4
- 238000012360 testing method Methods 0.000 claims description 4
- 239000007884 disintegrant Substances 0.000 claims description 3
- 239000013610 patient sample Substances 0.000 claims description 3
- 125000004105 2-pyridyl group Chemical group N1=C([*])C([H])=C([H])C([H])=C1[H] 0.000 claims description 2
- 206010005949 Bone cancer Diseases 0.000 claims description 2
- 208000018084 Bone neoplasm Diseases 0.000 claims description 2
- 208000003174 Brain Neoplasms Diseases 0.000 claims description 2
- 206010006187 Breast cancer Diseases 0.000 claims description 2
- 208000026310 Breast neoplasm Diseases 0.000 claims description 2
- 206010008342 Cervix carcinoma Diseases 0.000 claims description 2
- 206010017993 Gastrointestinal neoplasms Diseases 0.000 claims description 2
- 206010023825 Laryngeal cancer Diseases 0.000 claims description 2
- 206010058467 Lung neoplasm malignant Diseases 0.000 claims description 2
- 206010025323 Lymphomas Diseases 0.000 claims description 2
- 206010033128 Ovarian cancer Diseases 0.000 claims description 2
- 206010061535 Ovarian neoplasm Diseases 0.000 claims description 2
- 208000000453 Skin Neoplasms Diseases 0.000 claims description 2
- 208000024770 Thyroid neoplasm Diseases 0.000 claims description 2
- 208000006105 Uterine Cervical Neoplasms Diseases 0.000 claims description 2
- 201000010881 cervical cancer Diseases 0.000 claims description 2
- 238000001125 extrusion Methods 0.000 claims description 2
- 208000024519 eye neoplasm Diseases 0.000 claims description 2
- 239000000945 filler Substances 0.000 claims description 2
- 230000009477 glass transition Effects 0.000 claims description 2
- 206010023841 laryngeal neoplasm Diseases 0.000 claims description 2
- 239000000314 lubricant Substances 0.000 claims description 2
- 201000005202 lung cancer Diseases 0.000 claims description 2
- 208000020816 lung neoplasm Diseases 0.000 claims description 2
- 239000003550 marker Substances 0.000 claims description 2
- 125000002496 methyl group Chemical group [H]C([H])([H])* 0.000 claims description 2
- 201000008106 ocular cancer Diseases 0.000 claims description 2
- 108090000623 proteins and genes Proteins 0.000 claims description 2
- 201000000849 skin cancer Diseases 0.000 claims description 2
- 201000002510 thyroid cancer Diseases 0.000 claims description 2
- 125000001495 ethyl group Chemical group [H]C([H])([H])C([H])([H])* 0.000 claims 1
- 229940125904 compound 1 Drugs 0.000 description 5
- 238000004090 dissolution Methods 0.000 description 1
Applications Claiming Priority (9)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201461970595P | 2014-03-26 | 2014-03-26 | |
| US61/970,595 | 2014-03-26 | ||
| US201462048527P | 2014-09-10 | 2014-09-10 | |
| US62/048,527 | 2014-09-10 | ||
| PK162/2015 | 2015-03-25 | ||
| UY0001036046A UY36046A (es) | 2014-03-26 | 2015-03-25 | Formulaciones farmacéuticas, procesos para la preparación y métodos de uso |
| UY36046 | 2015-03-25 | ||
| PK16215 | 2015-03-25 | ||
| PCT/US2015/022792 WO2015148828A1 (en) | 2014-03-26 | 2015-03-26 | Pharmaceutical formulations of a pan-raf kinase inhibitor, processes for their preparation, and methods of use |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2017511313A JP2017511313A (ja) | 2017-04-20 |
| JP2017511313A5 true JP2017511313A5 (OSRAM) | 2018-04-26 |
| JP6571105B2 JP6571105B2 (ja) | 2019-09-04 |
Family
ID=57215543
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2016558714A Active JP6571105B2 (ja) | 2014-03-26 | 2015-03-26 | 汎rafキナーゼ阻害剤の薬学的製剤、その調製プロセス、及び使用方法 |
Country Status (17)
| Country | Link |
|---|---|
| US (1) | US10426782B2 (OSRAM) |
| EP (1) | EP3122334B1 (OSRAM) |
| JP (1) | JP6571105B2 (OSRAM) |
| CN (1) | CN106456787B (OSRAM) |
| BR (1) | BR112016022219B1 (OSRAM) |
| CA (1) | CA2943808C (OSRAM) |
| CO (1) | CO2016003340A2 (OSRAM) |
| CR (1) | CR20160483A (OSRAM) |
| DO (1) | DOP2016000254A (OSRAM) |
| EA (1) | EA031190B1 (OSRAM) |
| EC (1) | ECSP16084317A (OSRAM) |
| ES (1) | ES2744298T3 (OSRAM) |
| GE (1) | GEP20186932B (OSRAM) |
| MA (1) | MA39765A (OSRAM) |
| PE (1) | PE20170773A1 (OSRAM) |
| UY (1) | UY36046A (OSRAM) |
| WO (1) | WO2015148828A1 (OSRAM) |
Families Citing this family (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| ES2827024T3 (es) * | 2014-12-23 | 2021-05-19 | Dot Therapeutics 1 Inc | Combinación de inhibidores de Raf y de taxanos |
| WO2017066664A1 (en) * | 2015-10-16 | 2017-04-20 | Millennium Pharmaceuticals, Inc. | Combination therapy including a raf inhibitor for the treatment of colorectal cancer |
| TW201735949A (zh) | 2016-03-24 | 2017-10-16 | 千禧製藥公司 | 治療抗ctla4及抗pd-1組合治療中的胃腸道免疫相關不良事件之方法 |
| WO2017165491A1 (en) * | 2016-03-24 | 2017-09-28 | Millennium Pharmaceuticals, Inc. | Use of a pd-1 antagonist and a raf inhibitor in the treatment of cancer |
| US11760803B2 (en) | 2016-03-24 | 2023-09-19 | Takeda Pharmaceutical Company Limited | Methods of treating gastrointestinal immune-related adverse events in immune oncology treatments |
| US12122787B2 (en) | 2019-09-20 | 2024-10-22 | Shanghai Jemincare Pharmaceuticals Co., Ltd | Fused pyridone compound, and preparation method therefor and use thereof |
| EP4065122A4 (en) * | 2019-11-27 | 2023-12-27 | Day One Biopharmaceuticals, Inc. | Solid dispersion of pan-raf kinase inhibitor |
| AU2021376286A1 (en) * | 2020-11-06 | 2023-06-22 | Dana-Farber Cancer Institute, Inc. | Raf inhibitor for treating low grade glioma |
| CN117042772A (zh) * | 2020-11-06 | 2023-11-10 | 首日生物制药公司 | 用于治疗低级别胶质瘤的raf抑制剂 |
| WO2022178244A1 (en) * | 2021-02-19 | 2022-08-25 | Day One Biopharmaceuticals, Inc. | Combination of raf inhibitor and mek inhibitor |
| WO2023049807A2 (en) * | 2021-09-22 | 2023-03-30 | Sirnaomics, Inc. | Improved methods for preparing nanoparticle compositions containing histidine-lysine copolymers |
Family Cites Families (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4843155A (en) | 1987-11-19 | 1989-06-27 | Piotr Chomczynski | Product and process for isolating RNA |
| US5346994A (en) | 1992-01-28 | 1994-09-13 | Piotr Chomczynski | Shelf-stable product and process for isolating RNA, DNA and proteins |
| DE19509807A1 (de) * | 1995-03-21 | 1996-09-26 | Basf Ag | Verfahren zur Herstellung von Wirkstoffzubereitungen in Form einer festen Lösung des Wirkstoffs in einer Polymermatrix sowie mit diesem Verfahren hergestellte Wirkstoffzubereitungen |
| US20050220865A1 (en) | 2004-04-02 | 2005-10-06 | Koleng John J | Compressed composition comprising magnesium salt |
| ZA200806138B (en) | 2005-12-16 | 2009-11-25 | Hanmi Pharm Ind Co Ltd | Solid dispersion comprising an active ingredient having a low melting point and tablet for oral administration comprising same |
| KR100767349B1 (ko) * | 2006-08-01 | 2007-10-17 | 삼천당제약주식회사 | 페노피브레이트를 함유하는 경구용 약제 조성물 및 그의제조방법 |
| EP2079450A2 (en) | 2006-11-08 | 2009-07-22 | Novavax, INC. | Method of preparing solid dosage forms of multi-phasic pharmaceutical compositions |
| JPWO2008114859A1 (ja) * | 2007-03-22 | 2010-07-08 | アステラス製薬株式会社 | ピラゾール誘導体を含有する医薬組成物 |
| TWI444379B (zh) | 2007-06-29 | 2014-07-11 | Sunesis Pharmaceuticals Inc | 有用於作為Raf激酶抑制劑之化合物 |
| NZ592194A (en) | 2008-09-17 | 2013-04-26 | Mylan Inc | Reversed wet granulation process for preparing granulates and pharmaceutical products containing them |
| US20130172375A1 (en) * | 2011-12-13 | 2013-07-04 | Hoffmann-La Roche Inc. | Pharmaceutical composition |
| JP2015511632A (ja) * | 2012-03-30 | 2015-04-20 | 武田薬品工業株式会社 | メラノーマの治療におけるraf阻害剤およびmek阻害剤の投与 |
-
2015
- 2015-03-25 UY UY0001036046A patent/UY36046A/es not_active Application Discontinuation
- 2015-03-26 CN CN201580026318.XA patent/CN106456787B/zh active Active
- 2015-03-26 CR CR20160483A patent/CR20160483A/es unknown
- 2015-03-26 JP JP2016558714A patent/JP6571105B2/ja active Active
- 2015-03-26 WO PCT/US2015/022792 patent/WO2015148828A1/en not_active Ceased
- 2015-03-26 CA CA2943808A patent/CA2943808C/en active Active
- 2015-03-26 US US15/128,714 patent/US10426782B2/en active Active
- 2015-03-26 EP EP15716288.4A patent/EP3122334B1/en active Active
- 2015-03-26 ES ES15716288T patent/ES2744298T3/es active Active
- 2015-03-26 BR BR112016022219-9A patent/BR112016022219B1/pt active IP Right Grant
- 2015-03-26 EA EA201691918A patent/EA031190B1/ru not_active IP Right Cessation
- 2015-03-26 PE PE2017000171A patent/PE20170773A1/es unknown
- 2015-03-26 MA MA039765A patent/MA39765A/fr unknown
- 2015-03-26 GE GEAP201514304A patent/GEP20186932B/en unknown
-
2016
- 2016-09-23 DO DO2016000254A patent/DOP2016000254A/es unknown
- 2016-10-24 CO CONC2016/0003340A patent/CO2016003340A2/es unknown
- 2016-10-26 EC ECIEPI201684317A patent/ECSP16084317A/es unknown
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