DK2650012T3 - Behandling af prostatacancer i metastasestadium med degarelix. - Google Patents
Behandling af prostatacancer i metastasestadium med degarelix. Download PDFInfo
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- DK2650012T3 DK2650012T3 DK13168404.5T DK13168404T DK2650012T3 DK 2650012 T3 DK2650012 T3 DK 2650012T3 DK 13168404 T DK13168404 T DK 13168404T DK 2650012 T3 DK2650012 T3 DK 2650012T3
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Links
- 108010052004 acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide Proteins 0.000 title claims description 11
- MEUCPCLKGZSHTA-XYAYPHGZSA-N degarelix Chemical compound C([C@H](C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCCNC(C)C)C(=O)N1[C@@H](CCC1)C(=O)N[C@H](C)C(N)=O)NC(=O)[C@H](CC=1C=CC(NC(=O)[C@H]2NC(=O)NC(=O)C2)=CC=1)NC(=O)[C@H](CO)NC(=O)[C@@H](CC=1C=NC=CC=1)NC(=O)[C@@H](CC=1C=CC(Cl)=CC=1)NC(=O)[C@@H](CC=1C=C2C=CC=CC2=CC=1)NC(C)=O)C1=CC=C(NC(N)=O)C=C1 MEUCPCLKGZSHTA-XYAYPHGZSA-N 0.000 title claims description 11
- 229960002272 degarelix Drugs 0.000 title claims description 11
- 206010060862 Prostate cancer Diseases 0.000 title claims description 5
- 208000000236 Prostatic Neoplasms Diseases 0.000 title claims description 5
- 230000001394 metastastic effect Effects 0.000 title 1
- 206010061289 metastatic neoplasm Diseases 0.000 title 1
- 206010027476 Metastases Diseases 0.000 claims description 28
- 230000009401 metastasis Effects 0.000 claims description 28
- 210000000988 bone and bone Anatomy 0.000 claims description 14
- 102000004160 Phosphoric Monoester Hydrolases Human genes 0.000 claims description 10
- 108090000608 Phosphoric Monoester Hydrolases Proteins 0.000 claims description 10
- 210000002966 serum Anatomy 0.000 claims description 10
- 102000007066 Prostate-Specific Antigen Human genes 0.000 claims description 6
- 108010072866 Prostate-Specific Antigen Proteins 0.000 claims description 6
- 102000001554 Hemoglobins Human genes 0.000 claims description 4
- 108010054147 Hemoglobins Proteins 0.000 claims description 4
- 238000012423 maintenance Methods 0.000 claims description 4
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
- A61K38/08—Peptides having 5 to 11 amino acids
- A61K38/09—Luteinising hormone-releasing hormone [LHRH], i.e. Gonadotropin-releasing hormone [GnRH]; Related peptides
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
- A61K38/08—Peptides having 5 to 11 amino acids
-
- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
- A61P35/04—Antineoplastic agents specific for metastasis
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Epidemiology (AREA)
- Immunology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Gastroenterology & Hepatology (AREA)
- Reproductive Health (AREA)
- Endocrinology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Dermatology (AREA)
- Oncology (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Peptides Or Proteins (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Steroid Compounds (AREA)
- Medicines Containing Plant Substances (AREA)
- Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
Description
PATENTKRAV 1. Sammensætning omfattende degarelix til anvendelse i behandling af skeletal metastase eller knoglemetastase, hvor skeletmetastasen eller knoglemetastasen kommer fra prostatacancer. 2. Sammensætning til anvendelse ifølge krav 1, hvor behandlingen reducerer niveauet af skeletmetastase eller knoglemetastase eller vedligeholder det samme niveau af skeletmetastase eller knoglemetastase uden stigning. 3. Sammensætning omfattende degarelix til anvendelse til reducering af niveauet af skeletmetastase eller knoglemetastase eller vedligeholde det samme niveau af skeletmetastase eller knoglemetastase uden stigning, hvor skeletmetastase eller knoglemetastase kommer fra prostatacancer. 4. Sammensætning til anvendelse ifølge et hvilket som helst foregående krav, hvor behandlingen er behandling af et subjekt med et alkalisk serumphosphatase-(S-ALP)-basislinieniveau på omkring 150 IU/L eller højere forud for behandling. 5. Sammensætning til anvendelse ifølge et hvilket som helst foregående krav, hvor behandlingen er behandling af et subjekt med et alkalisk serumphosphatase-(S-ALP)-basislinieniveau på omkring 160 IU/L eller højere forud for behandling. 6. Sammensætning til anvendelse ifølge et hvilket som helst foregående krav, hvor behandlingen er behandling af et subjekt med et alkalisk serumphosphatase-(S-ALP)-basislinieniveau på omkring 200 IU/L eller højere forud for behandling. 7. Sammensætning til anvendelse ifølge et hvilket som helst foregående krav, hvor behandlingen er behandling af et subjekt med et alkalisk serumphosphatase-(S-ALP)-basislinieniveau på omkring 300 IU/L eller højere forud for behandling. 8. Sammensætning til anvendelse ifølge et hvilket som helst foregående krav, hvor behandlingen er behandling af et subjekt med hemoglobin-(Hb)-niveau på 130g/L eller mindre. 9. Sammensætning til anvendelse ifølge et hvilket som helst foregående krav til indgivelse ved en startdosis af degarelix på 160 til 320 mg; og ved en vedligeholdelsesdosis på 60 til 160 mg, én gang hver 20 til 36 dage derefter. 10. Sammensætning til anvendelse ifølge et hvilket som helst foregående krav til indgivelse ved en startdosis af degarelix på omkring 240 mg; og ved en vedligeholdelsesdosis på omkring 80 mg degarelix, én gang hver omtrent 28 dage af behandling. 11. Sammensætning til anvendelse ifølge et hvilket som helst af krav 1 til 8, hvor subjektet, som skal behandles, er identificeret ved et trin at teste det alkaliske se-rumphosphatase-(S-ALP)-niveauet hos et potentielt subjekt og så vælge subjektet til behandling, hvis subjektets S-ALP-basislinieniveau er 150 IU/L eller højere, f.eks. 160 IU/L eller højere, f.eks. 200 IU/L eller højere, f.eks. 300 IU/L eller højere. 12. Sammensætning til anvendelse ifølge et hvilket som helst af krav 1 til 8 hvor subjektet, som skal behandles, er identificeret ved et trin at teste hemoglobin-(Hb)-niveauet hos et potentielt subjekt og så vælge subjektet til behandling, hvis subjektets Hb- niveau er 130 g/L eller mindre. 13. Sammensætning til anvendelse ifølge et hvilket som helst af krav 1 til 8 hvor hos subjektet, som skal behandles, er identificeret ved et trin at teste det prostata-specifikke antigen-(PSA)-niveau hos et potentielt subjekt og så at vælge subjektet til behandling, hvis subjektets PSA-niveau er større end eller lig med 50 ng/mL.
Claims (13)
1. Sammensætning omfattende degarelix til anvendelse i behandling af skeletal metastase eller knoglemetastase, hvor skeletmetastasen eller knoglemetastasen kommer fra prostatacancer.
2. Sammensætning til anvendelse ifølge krav 1, hvor behandlingen reducerer niveauet af skeletmetastase eller knoglemetastase eller vedligeholder det samme niveau af skeletmetastase eller knoglemetastase uden stigning.
3. Sammensætning omfattende degarelix til anvendelse til reducering af niveauet af skeletmetastase eller knoglemetastase eller vedligeholde det samme niveau af skeletmetastase eller knoglemetastase uden stigning, hvor skeletmetastase eller knoglemetastase kommer fra prostatacancer.
4. Sammensætning til anvendelse ifølge et hvilket som helst foregående krav, hvor behandlingen er behandling af et subjekt med et alkalisk serumphosphatase-(S-ALP)-basislinieniveau på omkring 150 IU/L eller højere forud for behandling.
5. Sammensætning til anvendelse ifølge et hvilket som helst foregående krav, hvor behandlingen er behandling af et subjekt med et alkalisk serumphosphatase-(S-ALP)-basislinieniveau på omkring 160 IU/L eller højere forud for behandling.
6. Sammensætning til anvendelse ifølge et hvilket som helst foregående krav, hvor behandlingen er behandling af et subjekt med et alkalisk serumphosphatase-(S-ALP)-basislinieniveau på omkring 200 IU/L eller højere forud for behandling.
7. Sammensætning til anvendelse ifølge et hvilket som helst foregående krav, hvor behandlingen er behandling af et subjekt med et alkalisk serumphosphatase-(S-ALP)-basislinieniveau på omkring 300 IU/L eller højere forud for behandling.
8. Sammensætning til anvendelse ifølge et hvilket som helst foregående krav, hvor behandlingen er behandling af et subjekt med hemoglobin-(Hb)-niveau på 130g/L eller mindre.
9. Sammensætning til anvendelse ifølge et hvilket som helst foregående krav til indgivelse ved en startdosis af degarelix på 160 til 320 mg; og ved en vedligeholdelsesdosis på 60 til 160 mg, én gang hver 20 til 36 dage derefter.
10. Sammensætning til anvendelse ifølge et hvilket som helst foregående krav til indgivelse ved en startdosis af degarelix på omkring 240 mg; og ved en vedligeholdelsesdosis på omkring 80 mg degarelix, én gang hver omtrent 28 dage af behandling.
11. Sammensætning til anvendelse ifølge et hvilket som helst af krav 1 til 8, hvor subjektet, som skal behandles, er identificeret ved et trin at teste det alkaliske se-rumphosphatase-(S-ALP)-niveauet hos et potentielt subjekt og så vælge subjektet til behandling, hvis subjektets S-ALP-basislinieniveau er 150 IU/L eller højere, f.eks. 160 IU/L eller højere, f.eks. 200 IU/L eller højere, f.eks. 300 IU/L eller højere.
12. Sammensætning til anvendelse ifølge et hvilket som helst af krav 1 til 8 hvor subjektet, som skal behandles, er identificeret ved et trin at teste hemoglobin-(Hb)-niveauet hos et potentielt subjekt og så vælge subjektet til behandling, hvis subjektets Hb- niveau er 130 g/L eller mindre.
13. Sammensætning til anvendelse ifølge et hvilket som helst af krav 1 til 8 hvor hos subjektet, som skal behandles, er identificeret ved et trin at teste det prostata-specifikke antigen-(PSA)-niveau hos et potentielt subjekt og så at vælge subjektet til behandling, hvis subjektets PSA-niveau er større end eller lig med 50 ng/mL.
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US2774108P | 2008-02-11 | 2008-02-11 | |
| EP08250703 | 2008-02-29 | ||
| US14795609P | 2009-01-28 | 2009-01-28 | |
| EP09711390.6A EP2249859B1 (en) | 2008-02-11 | 2009-02-10 | Treatment of metastatic stage prostate cancer with degarelix |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DK2650012T3 true DK2650012T3 (da) | 2015-06-15 |
Family
ID=39718285
Family Applications (3)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK09711390.6T DK2249859T3 (da) | 2008-02-11 | 2009-02-10 | Behandling af metastatisk prostatacancer med degarelix |
| DK12165896T DK2505204T3 (da) | 2008-02-11 | 2009-02-10 | Fremgangsmåde til behandling af prostatakræft med GnRH-antagonisten degarelix |
| DK13168404.5T DK2650012T3 (da) | 2008-02-11 | 2009-02-10 | Behandling af prostatacancer i metastasestadium med degarelix. |
Family Applications Before (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK09711390.6T DK2249859T3 (da) | 2008-02-11 | 2009-02-10 | Behandling af metastatisk prostatacancer med degarelix |
| DK12165896T DK2505204T3 (da) | 2008-02-11 | 2009-02-10 | Fremgangsmåde til behandling af prostatakræft med GnRH-antagonisten degarelix |
Country Status (25)
| Country | Link |
|---|---|
| US (17) | US8841081B2 (da) |
| EP (7) | EP2650012B1 (da) |
| JP (12) | JP5876652B2 (da) |
| KR (8) | KR101542480B1 (da) |
| CN (4) | CN103990107A (da) |
| AU (2) | AU2009213751B2 (da) |
| BR (2) | BRPI0908127A2 (da) |
| CA (3) | CA2714445C (da) |
| CY (3) | CY1115561T1 (da) |
| DK (3) | DK2249859T3 (da) |
| EA (4) | EA036695B1 (da) |
| ES (3) | ES2532709T3 (da) |
| HK (1) | HK1198243A1 (da) |
| HR (3) | HRP20140665T1 (da) |
| IL (3) | IL207295A (da) |
| JO (1) | JOP20090061B1 (da) |
| MX (2) | MX2010008816A (da) |
| NZ (4) | NZ587057A (da) |
| PL (3) | PL2249859T3 (da) |
| PT (3) | PT2249859E (da) |
| RU (2) | RU2504394C2 (da) |
| SI (3) | SI2249859T1 (da) |
| TW (2) | TWI442932B (da) |
| WO (2) | WO2009101530A1 (da) |
| ZA (1) | ZA201005697B (da) |
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| GB0117057D0 (en) * | 2001-07-12 | 2001-09-05 | Ferring Bv | Pharmaceutical composition |
| JO3525B1 (ar) * | 2008-02-11 | 2020-07-05 | Ferring Int Center Sa | علاج سرطان البروستاتا في المرحلة النقيلية بدواء ديجاريليكس |
| TWI442932B (zh) * | 2008-02-11 | 2014-07-01 | Ferring Int Ct Sa | 以ＧｎＲＨ拮抗劑治療攝護腺癌的方法 |
| EP2424503B1 (en) * | 2009-05-01 | 2017-07-05 | Ferring BV | Composition for the treatment of prostate cancer |
| TW201043221A (en) * | 2009-05-06 | 2010-12-16 | Ferring Int Ct Sa | Kit and method for preparation of a Degarelix solution |
| US20110039787A1 (en) * | 2009-07-06 | 2011-02-17 | Ferring International Center S.A. | Compositions, kits and methods for treating benign prostate hyperplasia |
| FR2964323B1 (fr) * | 2010-09-08 | 2012-11-09 | Jean Pierre Raynaud | Utilisation de la testosterone chez un patient en deficit androgenique et atteint d'un cancer de la prostate |
| PT2632934T (pt) | 2010-10-27 | 2017-01-06 | Ferring Bv | Processo para o fabrico de degarelix e seus intermediários |
| EP2447276A1 (en) | 2010-10-27 | 2012-05-02 | Ferring B.V. | Process for the manufacture of Degarelix and its intermediates |
| JO3755B1 (ar) | 2011-01-26 | 2021-01-31 | Ferring Bv | تركيبات تستوستيرون |
| BR112013023050A8 (pt) * | 2011-03-09 | 2018-09-25 | G Pestell Richard | antagonista de ccr5, método para determinar se um indivíduo humano tendo câncer de próstata está sofrendo de ou sob o risco de desenvolver metástase, para identificar um antagonista de ccr5, método para determinar se um indivíduo humano tendo câncer de próstata está sofrendo de ou sob o risco de desenvolver metástase, para identificar um composto candidato, para produzir in vitro células epiteliais primárias, para diagnosticar câncer de próstata, para selecionar um tratamento para um indivíduo tendo um câncer/tumor de próstata, linhagem de célula, e, modelo animal |
| CN102204889B (zh) * | 2011-05-23 | 2013-09-18 | 蚌埠丰原涂山制药有限公司 | 一种醋酸地加瑞克冻干粉针剂及其制备方法 |
| WO2013104745A1 (en) * | 2012-01-13 | 2013-07-18 | Ferring Bv | Pharmaceutical composition |
| AU2013262977A1 (en) | 2012-05-14 | 2015-01-22 | Prostagene, Llc | Using modulators of CCR5 for treating cancer |
| SG11201407679PA (en) | 2012-06-01 | 2014-12-30 | Ferring Bv | Manufacture of degarelix |
| SG11201501870RA (en) | 2012-09-26 | 2015-04-29 | Aragon Pharmaceuticals Inc | Anti-androgens for the treatment of non-metastatic castrate-resistant prostate cancer |
| AR092707A1 (es) | 2012-09-28 | 2015-04-29 | Takeda Pharmaceuticals Co | Metodo de produccion de derivado de tienopirimidina |
| US10881659B2 (en) | 2013-03-15 | 2021-01-05 | Abbvie Inc. | Methods of treating heavy menstrual bleeding |
| WO2014186608A1 (en) * | 2013-05-15 | 2014-11-20 | Adverse Events, Inc. | System and method for surveillance and evaluation of safety risks associated with medical interventions |
| EP3185881B1 (en) * | 2014-08-26 | 2022-03-09 | Betanien Hospital | Methods, agents and compositions for treatment of inflammatory conditions |
| JP6941565B2 (ja) * | 2015-05-12 | 2021-09-29 | ドレクセル ユニバーシティ | がん転移を処置または防止するのに有用な化合物および組成物、ならびにこれらの使用法 |
| MA46361A (fr) | 2016-09-30 | 2021-03-31 | Myovant Sciences Gmbh | Traitement du cancer de la prostate |
| JP6990717B2 (ja) * | 2017-01-30 | 2022-02-03 | アンテヴ リミテッド | 少なくとも１種のｇｎｒｈアンタゴニストを含む組成物 |
| AU2018351714A1 (en) | 2017-10-16 | 2020-04-30 | Aragon Pharmaceuticals, Inc. | Anti-androgens for the treatment of non-metastatic castration-resistant prostate cancer |
| CN112261942A (zh) | 2018-04-19 | 2021-01-22 | 艾伯维公司 | 治疗重度月经出血的方法 |
| JP2021532160A (ja) * | 2018-08-01 | 2021-11-25 | アッヴィ・インコーポレイテッド | エラゴリックスに関する投与計画 |
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