JP2010209081A5 - - Google Patents
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- JP2010209081A5 JP2010209081A5 JP2010088515A JP2010088515A JP2010209081A5 JP 2010209081 A5 JP2010209081 A5 JP 2010209081A5 JP 2010088515 A JP2010088515 A JP 2010088515A JP 2010088515 A JP2010088515 A JP 2010088515A JP 2010209081 A5 JP2010209081 A5 JP 2010209081A5
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- cancer
- erbb2
- antibody
- medicament
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Description
「治療的有効量」という用語は、増殖抑制効果を有する量を指すために使用される。好ましくは、治療的有効量はアポトーシス活性を有するか、又は細胞死、好ましくは良性又は悪性の腫瘍細胞、特に癌細胞の死を誘発可能なものである。効力は、治療される状態に応じて、通常の方法で測定することができる。癌治療に対しては、効力は、例えば疾患の無増悪期間(TTP)の評価、又は奏効(RR)の決定により測定され得る(以下の実施例を参照)。
完全奏効
最小4週間で、放射線撮影及び/又は視覚的に明らかな腫瘍が全て消失。皮膚及び胸壁の完全反応がバイオプシーにより確認されなければならない。
最小4週間で、放射線撮影及び/又は視覚的に明らかな腫瘍が全て消失。皮膚及び胸壁の完全反応がバイオプシーにより確認されなければならない。
部分奏効
最小4週間で、全ての測定可能な病変の直交直径の生成物の合計が少なくとも50%低減。新しい病変は現れないか、又はいずれの病変も大きくならない。
やや奏効
全ての測定可能な病変の直交直径の生成物の合計が25%ないしは49%低減。新しい病変は現れないか、又はいずれの病変も大きくならない。
最小4週間で、全ての測定可能な病変の直交直径の生成物の合計が少なくとも50%低減。新しい病変は現れないか、又はいずれの病変も大きくならない。
やや奏効
全ての測定可能な病変の直交直径の生成物の合計が25%ないしは49%低減。新しい病変は現れないか、又はいずれの病変も大きくならない。
安定
測定可能な病変の大きさが25%を越えて変化しない。病変は現れなかった。
腫瘍の無増悪期間(TTP)を治療の開始から進行まで算出した。奏効の信頼限界は単一割合に対する厳密な方法を使用して算出した(Fleiss, JL, Statistical Methods for Rates and Proportions (2版), New York, Wiley, 1981, pp13-17)。
測定可能な病変の大きさが25%を越えて変化しない。病変は現れなかった。
腫瘍の無増悪期間(TTP)を治療の開始から進行まで算出した。奏効の信頼限界は単一割合に対する厳密な方法を使用して算出した(Fleiss, JL, Statistical Methods for Rates and Proportions (2版), New York, Wiley, 1981, pp13-17)。
Claims (19)
- アントラサイクリン誘導体を含まず、抗ErbB2抗体とアントラサイクリン誘導体以外の化学療法剤との組合せの有効量を含んでなる、ErbB2レセプターの過剰発現により特徴付けられる疾患になりやすいヒト又は該疾患と診断されたヒトの患者を治療するための医薬。
- 前記疾患が良性又は悪性腫瘍である請求項1の医薬。
- 前記疾患が癌である請求項1の医薬。
- 前記癌が乳癌、扁平上皮細胞癌、小細胞肺癌、非小細胞肺癌、胃腸癌、膵臓癌、神経膠芽細胞腫、子宮頸癌、卵巣癌、肝臓癌、膀胱癌、肝細胞腫、大腸癌、結腸直腸癌、子宮内膜癌、唾液腺癌、腎臓癌、前立腺癌、陰門癌、甲状腺癌、肝癌腫及び様々な種類の頭部及び頸部の癌からなる群から選択される請求項3の医薬。
- 前記癌が乳癌である請求項4の医薬。
- 前記癌が転移性乳癌である請求項5の医薬。
- 前記抗体がErbB2レセプターの細胞外ドメインに結合する請求項1の医薬。
- 前記抗体がErbB2細胞外ドメイン配列のエピトープ4D5に結合する請求項7の医薬。
- 前記抗体がヒト化4D5抗ErbB2抗体である請求項8の医薬。
- 前記化学療法剤がタキソイドである請求項1の医薬。
- 前記タキソイドがパクリタキセル又はドセタキセルである請求項10の医薬。
- 前記組合せの有効量が、単一の薬剤として個々に投与した場合の、前記抗ErbB2抗体と前記化学療法剤の有効量の合計よりも少ない請求項1の医薬。
- 効力が疾患の無増悪期間及び奏効を決定することにより測定されるものである請求項1の医薬。
- 容器と、抗ErbB2抗体を含有する該容器内の組成物と、該組成物と組合せてのアントラサイクリン型化学療法剤の使用を避ける旨のインストラクションを含むパッケージ挿入物とを含んでなる製造品。
- 前記組成物がErbB2レセプターの過剰発現により特徴付けられる病状を治療するために使用できることを示すラベルを容器上に又は容器に伴って更に具備している請求項14の製造品。
- 前記ラベルが、前記組成物が乳癌の治療に使用できることを示したものである請求項15の製造品。
- 前記抗ErbB2抗体がレセプターの細胞外ドメインに結合している請求項15の製造品。
- 前記抗ErbB2抗体がErbB2細胞外ドメイン配列のエピトープ4D5に結合している請求項17の製造品。
- 前記抗体がヒト化4D5抗ErbB2抗体である請求項18の製造品。
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US6934697P | 1997-12-12 | 1997-12-12 |
Related Parent Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2000539062A Division JP2002508397A (ja) | 1997-12-12 | 1998-12-10 | 抗ErbB2抗体を用いた治療方法 |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2012222108A Division JP2013056887A (ja) | 1997-12-12 | 2012-10-04 | 抗ErbB2抗体を用いた治療方法 |
Publications (2)
Publication Number | Publication Date |
---|---|
JP2010209081A JP2010209081A (ja) | 2010-09-24 |
JP2010209081A5 true JP2010209081A5 (ja) | 2011-10-06 |
Family
ID=22088358
Family Applications (7)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2000539062A Withdrawn JP2002508397A (ja) | 1997-12-12 | 1998-12-10 | 抗ErbB2抗体を用いた治療方法 |
JP2010088515A Pending JP2010209081A (ja) | 1997-12-12 | 2010-04-07 | 抗ErbB2抗体を用いた治療方法 |
JP2012222108A Withdrawn JP2013056887A (ja) | 1997-12-12 | 2012-10-04 | 抗ErbB2抗体を用いた治療方法 |
JP2015116874A Withdrawn JP2016006046A (ja) | 1997-12-12 | 2015-06-09 | 抗ErbB2抗体を用いた治療方法 |
JP2016185281A Pending JP2017039737A (ja) | 1997-12-12 | 2016-09-23 | 抗ErbB2抗体を用いた治療方法 |
JP2017075241A Withdrawn JP2017165737A (ja) | 1997-12-12 | 2017-04-05 | 抗ErbB2抗体を用いた治療方法 |
JP2018227941A Pending JP2019055979A (ja) | 1997-12-12 | 2018-12-05 | 抗ErbB2抗体を用いた治療方法 |
Family Applications Before (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2000539062A Withdrawn JP2002508397A (ja) | 1997-12-12 | 1998-12-10 | 抗ErbB2抗体を用いた治療方法 |
Family Applications After (5)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2012222108A Withdrawn JP2013056887A (ja) | 1997-12-12 | 2012-10-04 | 抗ErbB2抗体を用いた治療方法 |
JP2015116874A Withdrawn JP2016006046A (ja) | 1997-12-12 | 2015-06-09 | 抗ErbB2抗体を用いた治療方法 |
JP2016185281A Pending JP2017039737A (ja) | 1997-12-12 | 2016-09-23 | 抗ErbB2抗体を用いた治療方法 |
JP2017075241A Withdrawn JP2017165737A (ja) | 1997-12-12 | 2017-04-05 | 抗ErbB2抗体を用いた治療方法 |
JP2018227941A Pending JP2019055979A (ja) | 1997-12-12 | 2018-12-05 | 抗ErbB2抗体を用いた治療方法 |
Country Status (18)
Country | Link |
---|---|
US (11) | US7846441B1 (ja) |
EP (3) | EP2277919A1 (ja) |
JP (7) | JP2002508397A (ja) |
KR (7) | KR20080075042A (ja) |
CN (2) | CN1820734B (ja) |
AR (1) | AR020051A1 (ja) |
AU (1) | AU1908199A (ja) |
BR (1) | BR9815363A (ja) |
CA (2) | CA2730373A1 (ja) |
DK (1) | DK1037926T3 (ja) |
ES (1) | ES2450922T3 (ja) |
HK (2) | HK1030784A1 (ja) |
IL (4) | IL136201A0 (ja) |
NO (2) | NO20002957L (ja) |
NZ (1) | NZ504597A (ja) |
TR (1) | TR200001689T2 (ja) |
WO (1) | WO1999031140A1 (ja) |
ZA (1) | ZA9811162B (ja) |
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2011
- 2011-05-09 US US13/103,799 patent/US8309087B2/en not_active Expired - Fee Related
- 2011-07-14 IL IL214084A patent/IL214084A/en not_active IP Right Cessation
- 2011-07-18 US US13/185,329 patent/US8425908B2/en not_active Expired - Fee Related
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2012
- 2012-10-04 JP JP2012222108A patent/JP2013056887A/ja not_active Withdrawn
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2013
- 2013-03-15 US US13/841,146 patent/US20130209459A1/en not_active Abandoned
- 2013-12-26 US US14/141,232 patent/US20140341886A1/en not_active Abandoned
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2014
- 2014-09-17 IL IL234696A patent/IL234696A/en not_active IP Right Cessation
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2015
- 2015-06-09 JP JP2015116874A patent/JP2016006046A/ja not_active Withdrawn
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2016
- 2016-09-23 JP JP2016185281A patent/JP2017039737A/ja active Pending
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2017
- 2017-04-05 JP JP2017075241A patent/JP2017165737A/ja not_active Withdrawn
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2018
- 2018-12-05 JP JP2018227941A patent/JP2019055979A/ja active Pending
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2019
- 2019-04-23 US US16/392,300 patent/US20190240185A1/en not_active Abandoned
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