JP2007511499A - コンビネーション - Google Patents
コンビネーション Download PDFInfo
- Publication number
- JP2007511499A JP2007511499A JP2006538970A JP2006538970A JP2007511499A JP 2007511499 A JP2007511499 A JP 2007511499A JP 2006538970 A JP2006538970 A JP 2006538970A JP 2006538970 A JP2006538970 A JP 2006538970A JP 2007511499 A JP2007511499 A JP 2007511499A
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- JP
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- Prior art keywords
- cancer
- capecitabine
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- day
- dose
- 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.)
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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
- A61K31/495—Heterocyclic 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
- A61K31/498—Pyrazines or piperazines ortho- and peri-condensed with carbocyclic ring systems, e.g. quinoxaline, phenazine
-
- 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
- A61K31/495—Heterocyclic 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
-
- 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
- A61K31/495—Heterocyclic 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
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
- A61K31/513—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim having oxo groups directly attached to the heterocyclic ring, e.g. cytosine
-
- 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
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
- A61K31/7052—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
- A61K31/706—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom
- A61K31/7064—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines
- A61K31/7068—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines having oxo groups directly attached to the pyrimidine ring, e.g. cytidine, cytidylic acid
-
- 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
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Chemical & Material Sciences (AREA)
- Epidemiology (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Molecular Biology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
Description
多くの抗ガン剤が様々な作用機序に基づいて開発されてきた。
この研究の目的は、第1日目に3時間にわたって静脈内注入により投与するET−743と、第2日目から第15日目まで1日に2回経口で投与するカペシタビンとの併用療法の最大耐量(MTD)を求めることである。本研究のさらなる目的は、この処方計画の安全プロファイルを評価することである。
−適正な対症療法がされなかった悪心および嘔吐(N/V)を除いたグレード3〜4の非血液毒性、7日間未満のグレード3のトランスアミナイティス、および手足症候群。
−5日間のグレード4の好中球減少、または熱/敗血症を伴うグレード4の好中球減少。
−21日間を超える治療の延期。
−血小板数が25,000未満。
Claims (21)
- 治療に有効な量のET−743を治療に有効な量の5−フルオロウラシルまたはそのプロドラッグとの併用で投与する工程を含む、ガンを有するヒトの体の治療方法。
- ET−743を5−フルオロウラシルのプロドラッグとの併用で投与する、請求項1に記載の方法。
- ET−743をカペシタビンとの併用で投与する、請求項2に記載の方法。
- カペシタビンとET−743とを、異なる時刻に投与するための別個の薬剤として提供する、請求項3に記載の方法。
- カペシタビンを1500〜2500mg/m2/日の用量範囲で投与する、請求項4に記載の方法。
- ET−743を、0.75〜1.4mg/m2の用量範囲で投与する、請求項4に記載の方法。
- カペシタビンを最大で2000mg/m2/日の投与量で投与し、かつ、ET−743を最大で1.2mg/m2の投与量で投与する、請求項5または6に記載の方法。
- カペシタビンを約1600mg/m2/日の投与量で投与し、かつ、ET−743を約0.9mg/m2の投与量で投与する、請求項7に記載の方法。
- カペシタビンを経口で投与する、請求項5または6に記載の方法。
- ET−743を静脈注射で投与する、請求項9に記載の方法。
- ET−743の静脈注射の前記注入時間が最大で24時間である、請求項10に記載の方法。
- ET−743の静脈注射の前記注入時間が約3時間である、請求項11に記載の方法。
- ET−743の前記注入を1週間から6週間の間隔を置いて行う、請求項10に記載の方法。
- 前記ET−743の前記注入を21日ごとに1回行う、請求項13に記載の方法。
- 21日ごとに、ET−743の前記注入を第1日目に行い、カペシタビンの前記投与を第2日目から第15日目まで行う、請求項14に記載の方法。
- カペシタビンを1日に2回投与する、請求項15に記載の方法。
- 患者が、肉腫、骨肉腫、卵巣癌、乳癌、黒色腫、膣癌、結腸直腸癌、胃癌、腺癌、中皮腫、腎臓癌、子宮内膜癌、および肺癌から選ばれるガンを有する、請求項1〜16のいずれか一項に記載の方法。
- 前記患者が、肉腫、乳癌、胃癌、膣癌、および腺癌から選ばれるガンを有する、請求項17に記載の方法。
- 請求項1〜18のいずれか一項に記載の方法のための薬剤の調製における、ET−743の使用。
- 請求項1〜18のいずれか一項に記載の方法のための薬剤の調製における、5−フルオロウラシルまたはそのプロドラッグの使用。
- ET−743をカペシタビンとの併用で投与するためのメディカルキットであって、少なくとも1サイクル分の投与量単位のET−743の供給源と、投薬スケジュールに従ってET−743を投与するための印刷された取扱説明書とを含み、各投与量単位が治療のための有効量のET−743と製薬品として許容できる担体とを含む、メディカルキット。
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US51969003P | 2003-11-13 | 2003-11-13 | |
PCT/GB2004/050026 WO2005049031A1 (en) | 2003-11-13 | 2004-11-15 | Combination |
Publications (1)
Publication Number | Publication Date |
---|---|
JP2007511499A true JP2007511499A (ja) | 2007-05-10 |
Family
ID=34619369
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2006538970A Pending JP2007511499A (ja) | 2003-11-13 | 2004-11-15 | コンビネーション |
Country Status (15)
Country | Link |
---|---|
US (1) | US7622458B2 (ja) |
EP (1) | EP1689404B9 (ja) |
JP (1) | JP2007511499A (ja) |
AT (1) | ATE406897T1 (ja) |
CA (1) | CA2544320A1 (ja) |
CY (1) | CY1108629T1 (ja) |
DE (1) | DE602004016376D1 (ja) |
DK (1) | DK1689404T3 (ja) |
ES (1) | ES2314470T3 (ja) |
HR (1) | HRP20080598T3 (ja) |
PL (1) | PL1689404T3 (ja) |
PT (1) | PT1689404E (ja) |
RS (1) | RS50692B (ja) |
SI (1) | SI1689404T1 (ja) |
WO (1) | WO2005049031A1 (ja) |
Families Citing this family (16)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
MY164077A (en) * | 1999-05-13 | 2017-11-30 | Pharma Mar Sa | Compositions and uses of et743 for treating cancer |
MXPA02011319A (es) | 2000-05-15 | 2003-06-06 | Pharma Mar Sa | Analogos antitumorales de ecteinascidina 743. |
CZ20031327A3 (cs) * | 2000-11-06 | 2003-11-12 | Pharma Mar, S. A. | Užití ET-743 k výrobě léků pro účinnou protinádorovou léčbu |
GB0117402D0 (en) * | 2001-07-17 | 2001-09-05 | Pharma Mar Sa | New antitumoral derivatives of et-743 |
GB0202544D0 (en) | 2002-02-04 | 2002-03-20 | Pharma Mar Sa | The synthesis of naturally occuring ecteinascidins and related compounds |
GB0312407D0 (en) * | 2003-05-29 | 2003-07-02 | Pharma Mar Sau | Treatment |
CA2544320A1 (en) | 2003-11-13 | 2005-06-02 | Pharma Mar, S.A.U. | Method of treating cancer using a combination comprising et-743 and 5-fluorouracil |
CN1897949A (zh) * | 2003-11-14 | 2007-01-17 | 马尔药品公司 | 包含使用et-743和紫杉醇来治疗癌症的联合疗法 |
SI1827500T1 (sl) * | 2004-10-26 | 2009-10-31 | Pharma Mar Sa | Pegiliran liposomski doksorubicin v kombinaciji s ekteinescidinom 743 |
SI1658848T1 (sl) | 2004-10-29 | 2007-12-31 | Pharma Mar Sa | Formulacije vsebujoäśe ekteinascidin in disaharid |
JP2009501734A (ja) * | 2005-07-21 | 2009-01-22 | ヌボ・リサーチ・インコーポレイテッド | 癌の治療方法 |
GB0522082D0 (en) * | 2005-10-31 | 2005-12-07 | Pharma Mar Sa | Formulations |
AU2008313634A1 (en) * | 2007-10-19 | 2009-04-23 | Pharma Mar, S.A. | Prognostic molecular markers for ET-743 treatment |
RS54648B1 (en) * | 2010-11-12 | 2016-08-31 | Pharma Mar S.A. | COMBINED THERAPY WITH ANTITUMOR ALKALOID |
JOP20190254A1 (ar) | 2017-04-27 | 2019-10-27 | Pharma Mar Sa | مركبات مضادة للأورام |
KR20200110452A (ko) * | 2018-02-12 | 2020-09-23 | 어레이 바이오파마 인크. | 담도암을 치료하기 위한 방법 및 조합 요법 |
Citations (3)
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WO2002036135A2 (en) * | 2000-11-06 | 2002-05-10 | Pharma Mar, S.A. | Compositions for antitumour treatment containing ecteinascidin 743 |
WO2003039571A1 (en) * | 2001-10-19 | 2003-05-15 | Pharmamar S.A. | Improved use of antitumoral compound in cancer therapy |
JP2003523980A (ja) * | 2000-02-28 | 2003-08-12 | アベンテイス・フアルマ・ソシエテ・アノニム | カンプトテシンおよびピリミジン誘導体を含んでなる癌の処置のための組成物 |
Family Cites Families (28)
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US5149804A (en) | 1990-11-30 | 1992-09-22 | The Board Of Trustees Of The University Of Illinois | Ecteinascidins 736 and 722 |
US5256663A (en) | 1986-06-09 | 1993-10-26 | The Board Of Trustees Of The University Of Illinois | Compositions comprising ecteinascidins and a method of treating herpes simplex virus infections therewith |
US5089273A (en) | 1986-06-09 | 1992-02-18 | Board Of Trustees Of The University Of Illinois | Ecteinascidins 729, 743, 745, 759A, 759B and 770 |
DE3635711A1 (de) | 1986-10-21 | 1988-04-28 | Knoll Ag | 5-nitrobenzo(de)isochinolin-1,3-dione, ihre herstellung und verwendung |
FR2697752B1 (fr) | 1992-11-10 | 1995-04-14 | Rhone Poulenc Rorer Sa | Compositions antitumorales contenant des dérivés du taxane. |
AU671491B2 (en) | 1992-12-18 | 1996-08-29 | F. Hoffmann-La Roche Ag | N-oxycarbonyl substituted 5'-deoxy-5-fluorcytidines |
US5478932A (en) | 1993-12-02 | 1995-12-26 | The Board Of Trustees Of The University Of Illinois | Ecteinascidins |
US20040059112A1 (en) | 1994-02-18 | 2004-03-25 | Rinehart Kenneth L. | Ecteinascidins |
GB9508195D0 (en) | 1995-04-20 | 1995-06-07 | Univ British Columbia | Novel biologically active compounds and compositions,their use and derivation |
US5721362A (en) | 1996-09-18 | 1998-02-24 | President And Fellows Of Harvard College | Process for producing ecteinascidin compounds |
US5985876A (en) | 1997-04-15 | 1999-11-16 | Univ Illinois | Nucleophile substituted ecteinascidins and N-oxide ecteinascidins |
US6124293A (en) | 1998-04-06 | 2000-09-26 | The Board Of Trustees Of The University Of Illinois | Semi-synthetic ecteinascidins |
ES2239442T3 (es) | 1998-05-11 | 2005-09-16 | Pharma Mar, S.A. | Metabolitos de ecteinascidina 743. |
MY164077A (en) * | 1999-05-13 | 2017-11-30 | Pharma Mar Sa | Compositions and uses of et743 for treating cancer |
MY130271A (en) | 1999-05-14 | 2007-06-29 | Pharma Mar Sa | Hemisynthetic method and new compounds |
PT1280809E (pt) | 2000-04-12 | 2005-11-30 | Pharma Mar Sa | Derivados antitumorais de ecteinascidina |
EP1356097A2 (en) | 2000-08-11 | 2003-10-29 | City of Hope | The anti-neoplastic agent et-743 inhibits trans activation by sxr |
EP1360337A1 (en) | 2001-02-09 | 2003-11-12 | The Regents Of The University Of California | Ecteinascidin family compounds: compositions and methods |
GB0121285D0 (en) | 2001-09-03 | 2001-10-24 | Cancer Res Ventures Ltd | Anti-cancer combinations |
US20040019027A1 (en) | 2002-04-12 | 2004-01-29 | Barry Forman | Method of treating cerebrotendinous xanthomatosis |
GB0312407D0 (en) | 2003-05-29 | 2003-07-02 | Pharma Mar Sau | Treatment |
GB0324201D0 (en) | 2003-10-15 | 2003-11-19 | Pharma Mar Sau | Improved antitumoral combinations |
CA2544320A1 (en) | 2003-11-13 | 2005-06-02 | Pharma Mar, S.A.U. | Method of treating cancer using a combination comprising et-743 and 5-fluorouracil |
CN1897949A (zh) | 2003-11-14 | 2007-01-17 | 马尔药品公司 | 包含使用et-743和紫杉醇来治疗癌症的联合疗法 |
GB0326486D0 (en) | 2003-11-14 | 2003-12-17 | Pharma Mar Sau | Combination treatment |
CN101068596A (zh) | 2004-09-29 | 2007-11-07 | 法马马私人股份有限公司 | 艾可特耐思地作抗炎药 |
SI1827500T1 (sl) | 2004-10-26 | 2009-10-31 | Pharma Mar Sa | Pegiliran liposomski doksorubicin v kombinaciji s ekteinescidinom 743 |
SI1658848T1 (sl) | 2004-10-29 | 2007-12-31 | Pharma Mar Sa | Formulacije vsebujoäśe ekteinascidin in disaharid |
-
2004
- 2004-11-15 CA CA002544320A patent/CA2544320A1/en not_active Abandoned
- 2004-11-15 EP EP04798717A patent/EP1689404B9/en active Active
- 2004-11-15 JP JP2006538970A patent/JP2007511499A/ja active Pending
- 2004-11-15 PL PL04798717T patent/PL1689404T3/pl unknown
- 2004-11-15 PT PT04798717T patent/PT1689404E/pt unknown
- 2004-11-15 US US10/579,160 patent/US7622458B2/en not_active Expired - Fee Related
- 2004-11-15 RS RSP-2008/0567A patent/RS50692B/sr unknown
- 2004-11-15 DE DE602004016376T patent/DE602004016376D1/de active Active
- 2004-11-15 AT AT04798717T patent/ATE406897T1/de active
- 2004-11-15 DK DK04798717T patent/DK1689404T3/da active
- 2004-11-15 ES ES04798717T patent/ES2314470T3/es active Active
- 2004-11-15 WO PCT/GB2004/050026 patent/WO2005049031A1/en active Application Filing
- 2004-11-15 SI SI200430928T patent/SI1689404T1/sl unknown
-
2008
- 2008-12-02 CY CY20081101393T patent/CY1108629T1/el unknown
- 2008-12-02 HR HR20080598T patent/HRP20080598T3/xx unknown
Patent Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2003523980A (ja) * | 2000-02-28 | 2003-08-12 | アベンテイス・フアルマ・ソシエテ・アノニム | カンプトテシンおよびピリミジン誘導体を含んでなる癌の処置のための組成物 |
WO2002036135A2 (en) * | 2000-11-06 | 2002-05-10 | Pharma Mar, S.A. | Compositions for antitumour treatment containing ecteinascidin 743 |
WO2003039571A1 (en) * | 2001-10-19 | 2003-05-15 | Pharmamar S.A. | Improved use of antitumoral compound in cancer therapy |
Also Published As
Publication number | Publication date |
---|---|
RS50692B (sr) | 2010-06-30 |
DE602004016376D1 (de) | 2008-10-16 |
US7622458B2 (en) | 2009-11-24 |
DK1689404T3 (da) | 2009-01-26 |
SI1689404T1 (sl) | 2009-02-28 |
WO2005049031A1 (en) | 2005-06-02 |
US20070190164A1 (en) | 2007-08-16 |
PT1689404E (pt) | 2008-12-15 |
CA2544320A1 (en) | 2005-06-02 |
CY1108629T1 (el) | 2014-04-09 |
ES2314470T3 (es) | 2009-03-16 |
EP1689404B1 (en) | 2008-09-03 |
ATE406897T1 (de) | 2008-09-15 |
EP1689404A1 (en) | 2006-08-16 |
HRP20080598T3 (en) | 2009-01-31 |
EP1689404B9 (en) | 2009-04-22 |
PL1689404T3 (pl) | 2009-02-27 |
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Free format text: JAPANESE INTERMEDIATE CODE: A02 Effective date: 20120214 |