DK2827858T3 - ADMINISTRATION OF ANTI-TUMOR AGENT - Google Patents
ADMINISTRATION OF ANTI-TUMOR AGENT Download PDFInfo
- Publication number
- DK2827858T3 DK2827858T3 DK13711004.5T DK13711004T DK2827858T3 DK 2827858 T3 DK2827858 T3 DK 2827858T3 DK 13711004 T DK13711004 T DK 13711004T DK 2827858 T3 DK2827858 T3 DK 2827858T3
- Authority
- DK
- Denmark
- Prior art keywords
- day
- compound
- days
- treatment
- pharmaceutical product
- Prior art date
Links
- 239000002246 antineoplastic agent Substances 0.000 title 1
- 206010028980 Neoplasm Diseases 0.000 claims description 40
- 229940126062 Compound A Drugs 0.000 claims description 33
- NLDMNSXOCDLTTB-UHFFFAOYSA-N Heterophylliin A Natural products O1C2COC(=O)C3=CC(O)=C(O)C(O)=C3C3=C(O)C(O)=C(O)C=C3C(=O)OC2C(OC(=O)C=2C=C(O)C(O)=C(O)C=2)C(O)C1OC(=O)C1=CC(O)=C(O)C(O)=C1 NLDMNSXOCDLTTB-UHFFFAOYSA-N 0.000 claims description 33
- 239000000825 pharmaceutical preparation Substances 0.000 claims description 13
- 229940127557 pharmaceutical product Drugs 0.000 claims description 13
- 201000011510 cancer Diseases 0.000 claims description 11
- 206010006187 Breast cancer Diseases 0.000 claims description 4
- 208000026310 Breast neoplasm Diseases 0.000 claims description 4
- 206010009944 Colon cancer Diseases 0.000 claims description 4
- 208000008839 Kidney Neoplasms Diseases 0.000 claims description 4
- 206010060862 Prostate cancer Diseases 0.000 claims description 4
- 208000000236 Prostatic Neoplasms Diseases 0.000 claims description 4
- 206010038389 Renal cancer Diseases 0.000 claims description 4
- 239000004480 active ingredient Substances 0.000 claims description 4
- 201000010982 kidney cancer Diseases 0.000 claims description 4
- 206010039491 Sarcoma Diseases 0.000 claims description 3
- 206010058467 Lung neoplasm malignant Diseases 0.000 claims description 2
- 201000005202 lung cancer Diseases 0.000 claims description 2
- 208000020816 lung neoplasm Diseases 0.000 claims description 2
- 208000001333 Colorectal Neoplasms Diseases 0.000 claims 1
- 241001465754 Metazoa Species 0.000 description 11
- 230000004083 survival effect Effects 0.000 description 9
- 230000037396 body weight Effects 0.000 description 7
- 150000001875 compounds Chemical class 0.000 description 6
- 238000002474 experimental method Methods 0.000 description 6
- 231100000419 toxicity Toxicity 0.000 description 6
- 230000001988 toxicity Effects 0.000 description 6
- 241000699670 Mus sp. Species 0.000 description 5
- 239000000047 product Substances 0.000 description 5
- RWRDLPDLKQPQOW-UHFFFAOYSA-N Pyrrolidine Chemical compound C1CCNC1 RWRDLPDLKQPQOW-UHFFFAOYSA-N 0.000 description 3
- 230000000259 anti-tumor effect Effects 0.000 description 3
- 210000000481 breast Anatomy 0.000 description 3
- 230000008859 change Effects 0.000 description 3
- 210000001072 colon Anatomy 0.000 description 3
- 208000029742 colonic neoplasm Diseases 0.000 description 3
- 230000036541 health Effects 0.000 description 3
- 230000000977 initiatory effect Effects 0.000 description 3
- 238000000034 method Methods 0.000 description 3
- 210000002307 prostate Anatomy 0.000 description 3
- 241000699666 Mus <mouse, genus> Species 0.000 description 2
- 238000013461 design Methods 0.000 description 2
- 238000011156 evaluation Methods 0.000 description 2
- 230000005764 inhibitory process Effects 0.000 description 2
- 238000005259 measurement Methods 0.000 description 2
- 230000008520 organization Effects 0.000 description 2
- 201000008968 osteosarcoma Diseases 0.000 description 2
- 229920000642 polymer Polymers 0.000 description 2
- 239000000725 suspension Substances 0.000 description 2
- 238000012360 testing method Methods 0.000 description 2
- 206010043554 thrombocytopenia Diseases 0.000 description 2
- 210000001519 tissue Anatomy 0.000 description 2
- 230000004614 tumor growth Effects 0.000 description 2
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 2
- 230000004580 weight loss Effects 0.000 description 2
- TVTXCJFHQKSQQM-LJQIRTBHSA-N 4-[[(2r,3s,4r,5s)-3-(3-chloro-2-fluorophenyl)-4-(4-chloro-2-fluorophenyl)-4-cyano-5-(2,2-dimethylpropyl)pyrrolidine-2-carbonyl]amino]-3-methoxybenzoic acid Chemical compound COC1=CC(C(O)=O)=CC=C1NC(=O)[C@H]1[C@H](C=2C(=C(Cl)C=CC=2)F)[C@@](C#N)(C=2C(=CC(Cl)=CC=2)F)[C@H](CC(C)(C)C)N1 TVTXCJFHQKSQQM-LJQIRTBHSA-N 0.000 description 1
- 102000012199 E3 ubiquitin-protein ligase Mdm2 Human genes 0.000 description 1
- 108050002772 E3 ubiquitin-protein ligase Mdm2 Proteins 0.000 description 1
- 238000010824 Kaplan-Meier survival analysis Methods 0.000 description 1
- ZDXPYRJPNDTMRX-VKHMYHEASA-N L-glutamine Chemical compound OC(=O)[C@@H](N)CCC(N)=O ZDXPYRJPNDTMRX-VKHMYHEASA-N 0.000 description 1
- 229930182816 L-glutamine Natural products 0.000 description 1
- 229940083338 MDM2 inhibitor Drugs 0.000 description 1
- 239000012819 MDM2-Inhibitor Substances 0.000 description 1
- 238000000692 Student's t-test Methods 0.000 description 1
- 239000008186 active pharmaceutical agent Substances 0.000 description 1
- 238000004458 analytical method Methods 0.000 description 1
- 238000010171 animal model Methods 0.000 description 1
- 230000000118 anti-neoplastic effect Effects 0.000 description 1
- 230000006907 apoptotic process Effects 0.000 description 1
- 230000008901 benefit Effects 0.000 description 1
- 230000033228 biological regulation Effects 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 238000002591 computed tomography Methods 0.000 description 1
- 230000034994 death Effects 0.000 description 1
- 230000003111 delayed effect Effects 0.000 description 1
- LOKCTEFSRHRXRJ-UHFFFAOYSA-I dipotassium trisodium dihydrogen phosphate hydrogen phosphate dichloride Chemical compound P(=O)(O)(O)[O-].[K+].P(=O)(O)([O-])[O-].[Na+].[Na+].[Cl-].[K+].[Cl-].[Na+] LOKCTEFSRHRXRJ-UHFFFAOYSA-I 0.000 description 1
- 239000002552 dosage form Substances 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 229940088679 drug related substance Drugs 0.000 description 1
- 238000003304 gavage Methods 0.000 description 1
- 230000012010 growth Effects 0.000 description 1
- 239000007943 implant Substances 0.000 description 1
- 238000005462 in vivo assay Methods 0.000 description 1
- 230000002401 inhibitory effect Effects 0.000 description 1
- 230000003902 lesion Effects 0.000 description 1
- 238000001325 log-rank test Methods 0.000 description 1
- 210000004072 lung Anatomy 0.000 description 1
- 238000002595 magnetic resonance imaging Methods 0.000 description 1
- 108010082117 matrigel Proteins 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- 238000011275 oncology therapy Methods 0.000 description 1
- 238000009520 phase I clinical trial Methods 0.000 description 1
- 239000002953 phosphate buffered saline Substances 0.000 description 1
- 229920000136 polysorbate Polymers 0.000 description 1
- 239000000843 powder Substances 0.000 description 1
- 239000002244 precipitate Substances 0.000 description 1
- 238000011084 recovery Methods 0.000 description 1
- 238000009097 single-agent therapy Methods 0.000 description 1
- 239000007962 solid dispersion Substances 0.000 description 1
- 238000007619 statistical method Methods 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 208000024891 symptom Diseases 0.000 description 1
- 238000012353 t test Methods 0.000 description 1
- 239000003826 tablet Substances 0.000 description 1
- 230000003442 weekly effect Effects 0.000 description 1
Classifications
-
- 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
- A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
-
- 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
- A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
- A61K31/401—Proline; Derivatives thereof, e.g. captopril
-
- 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
- A61K9/146—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 organic macromolecular compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2121/00—Preparations for use in therapy
Landscapes
- Health & Medical Sciences (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
- Heterocyclic Carbon Compounds Containing A Hetero Ring Having Oxygen Or Sulfur (AREA)
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201261612429P | 2012-03-19 | 2012-03-19 | |
| PCT/EP2013/055324 WO2013139687A1 (en) | 2012-03-19 | 2013-03-15 | Method for administration of an anti tumor agent |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DK2827858T3 true DK2827858T3 (en) | 2016-08-22 |
Family
ID=47913395
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK13711004.5T DK2827858T3 (en) | 2012-03-19 | 2013-03-15 | ADMINISTRATION OF ANTI-TUMOR AGENT |
Country Status (21)
| Country | Link |
|---|---|
| US (4) | US20130245089A1 (https=) |
| EP (1) | EP2827858B1 (https=) |
| JP (2) | JP6224690B2 (https=) |
| KR (4) | KR102438597B1 (https=) |
| CN (2) | CN104203232A (https=) |
| BR (1) | BR112014018135A8 (https=) |
| CA (1) | CA2859940C (https=) |
| CY (1) | CY1118070T1 (https=) |
| DK (1) | DK2827858T3 (https=) |
| ES (1) | ES2593066T3 (https=) |
| HK (1) | HK1204934A1 (https=) |
| HR (1) | HRP20161295T1 (https=) |
| HU (1) | HUE029933T2 (https=) |
| LT (1) | LT2827858T (https=) |
| MX (1) | MX356948B (https=) |
| PL (1) | PL2827858T3 (https=) |
| PT (1) | PT2827858T (https=) |
| RS (1) | RS55250B1 (https=) |
| RU (1) | RU2638795C2 (https=) |
| SI (1) | SI2827858T1 (https=) |
| WO (1) | WO2013139687A1 (https=) |
Families Citing this family (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112353762A (zh) * | 2013-01-22 | 2021-02-12 | 霍夫曼-拉罗奇有限公司 | 具有改善的生物利用度的药物组合物 |
| EP3459933B1 (en) | 2014-04-15 | 2022-08-24 | F. Hoffmann-La Roche AG | Solid forms of a pharmaceutically active compound |
| TW201613576A (en) | 2014-06-26 | 2016-04-16 | Novartis Ag | Intermittent dosing of MDM2 inhibitor |
| EP3204776B1 (en) * | 2014-10-10 | 2019-09-04 | F.Hoffmann-La Roche Ag | Methods for personalizing patient cancer therapy with an mdm2 antagonist |
| AU2017246452C1 (en) | 2016-04-06 | 2021-06-03 | The Regents Of The University Of Michigan | MDM2 protein degraders |
| MX388093B (es) | 2016-11-15 | 2025-03-19 | Novartis Ag | Dosis y regimen para inhibidores de la interaccion hdm2-p53. |
| US20210122831A1 (en) | 2017-03-27 | 2021-04-29 | Noile-Immune Biotech, Inc. | Chimeric antigen receptor |
| CA3052543A1 (en) | 2017-03-31 | 2018-10-04 | Novartis Ag | Dose and regimen for an hdm2-p53 interaction inhibitor in hematological tumors |
| TWI791794B (zh) | 2018-03-20 | 2023-02-11 | 瑞士商諾華公司 | 藥物組合 |
| MX2021007391A (es) | 2018-12-20 | 2021-09-23 | Novartis Ag | Regimenes de baja dosis extendida para inhibidores de mdm2. |
Family Cites Families (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101595107A (zh) * | 2006-06-30 | 2009-12-02 | 先灵公司 | 能提高p53活性的有取代哌啶及其用途 |
| WO2008076415A1 (en) | 2006-12-14 | 2008-06-26 | Exelixis, Inc. | Methods of using mek inhibitors |
| US8354444B2 (en) * | 2008-09-18 | 2013-01-15 | Hoffmann-La Roche Inc. | Substituted pyrrolidine-2-carboxamides |
| US20120010235A1 (en) * | 2010-07-12 | 2012-01-12 | Xin-Jie Chu | N-substituted pyrrolidines |
| US9216170B2 (en) | 2012-03-19 | 2015-12-22 | Hoffmann-La Roche Inc. | Combination therapy for proliferative disorders |
-
2013
- 2013-02-05 US US13/759,647 patent/US20130245089A1/en not_active Abandoned
- 2013-03-15 EP EP13711004.5A patent/EP2827858B1/en active Active
- 2013-03-15 KR KR1020217003250A patent/KR102438597B1/ko active Active
- 2013-03-15 RU RU2014141365A patent/RU2638795C2/ru active
- 2013-03-15 WO PCT/EP2013/055324 patent/WO2013139687A1/en not_active Ceased
- 2013-03-15 CA CA2859940A patent/CA2859940C/en active Active
- 2013-03-15 CN CN201380015189.5A patent/CN104203232A/zh active Pending
- 2013-03-15 DK DK13711004.5T patent/DK2827858T3/en active
- 2013-03-15 RS RS20160860A patent/RS55250B1/sr unknown
- 2013-03-15 PT PT137110045T patent/PT2827858T/pt unknown
- 2013-03-15 MX MX2014010586A patent/MX356948B/es active IP Right Grant
- 2013-03-15 PL PL13711004T patent/PL2827858T3/pl unknown
- 2013-03-15 KR KR1020147026019A patent/KR20140133583A/ko not_active Ceased
- 2013-03-15 HR HRP20161295TT patent/HRP20161295T1/hr unknown
- 2013-03-15 JP JP2015500851A patent/JP6224690B2/ja active Active
- 2013-03-15 ES ES13711004.5T patent/ES2593066T3/es active Active
- 2013-03-15 LT LTEP13711004.5T patent/LT2827858T/lt unknown
- 2013-03-15 HK HK15105538.1A patent/HK1204934A1/xx unknown
- 2013-03-15 KR KR1020197008801A patent/KR20190035957A/ko not_active Ceased
- 2013-03-15 KR KR1020167019798A patent/KR20160089549A/ko not_active Ceased
- 2013-03-15 BR BR112014018135A patent/BR112014018135A8/pt not_active Application Discontinuation
- 2013-03-15 SI SI201330310A patent/SI2827858T1/sl unknown
- 2013-03-15 CN CN201910030832.0A patent/CN110013478A/zh active Pending
- 2013-03-15 HU HUE13711004A patent/HUE029933T2/en unknown
-
2015
- 2015-01-14 US US14/596,747 patent/US20150126575A1/en not_active Abandoned
-
2016
- 2016-10-05 CY CY20161100996T patent/CY1118070T1/el unknown
- 2016-10-06 JP JP2016197838A patent/JP2017061461A/ja active Pending
-
2019
- 2019-07-12 US US16/510,256 patent/US20190328708A1/en not_active Abandoned
-
2020
- 2020-11-18 US US16/951,153 patent/US11738003B2/en active Active
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