JP2009514870A - mTORインヒビター、ハーセプチン、および/またはHKI−272の抗悪性腫瘍性組み合わせ - Google Patents
mTORインヒビター、ハーセプチン、および/またはHKI−272の抗悪性腫瘍性組み合わせ Download PDFInfo
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Abstract
Description
本発明は、HER2の過剰発現または増幅に関連する新生物の処置のための、mTORインヒビターおよび/またはHKI−272とのハーセプチン(herceptin)の組み合わせの使用に関する。
本発明は、新生物の処置におけるハーセプチン、mTORインヒビターおよび/またはHKI−272を含む組み合わせ(併用)の使用を提供する。従って、本発明は、ハーセプチンとmTORインヒビターとの併用使用、ハーセプチンとHKI−272との併用使用、mTORインヒビターとHKI−272との併用使用、またはハーセプチンとmTORインヒビターおよびHKI−272との併用使用を提供する。本発明はさらに、ハーセプチンを哺乳動物において新生物を処置するのにおける同時、別々または連続的な使用のために処方されたmTORインヒビターおよび/またはHKI−272と組み合わせて含有する生成物を提供する。本発明はまた、乳癌の初期段階のアジュバントおよび/またはネオアジュバント療法として有用である。以下の詳細な説明は、テムシロリムスを例示する。しかし、他のmTORインヒビターが、本明細書に記載される方法、組み合わせおよび生成物においてテムシロリムスについて置き換えられてもよい。
式中、R1はハロゲンであり;
R2はピリジニル、チオフェン、ピリミジン、チアゾールまたはフェニルであって、場合により最大3つまでの置換基で置換され;
R3は−O−または−S−であり;
R4はメチルまたはCH2CH2OCH3であり;
R5はエチルまたはメチルであり;そして
nはOまたは1である。
これらの化合物であって、HKI−272が一種である化合物は、強力なHER−2インヒビターとして作用する能力によって特徴付けられる。例えば、米国特許第6,288,082号および米国特許第6,297,258号を参照のこと。これらの化合物およびそれらの調製は、米国特許出願公開第2005/0059678号に詳細に記載される。簡便のために、HKI−272を本明細書を通じて用いる。しかし、上記で提供される構造の化合物が、下に詳細に記載される、mTORインヒビターおよび/またはハーセプチンと組み合わせて、HKI−272と置換されてもよい。
本発明は、単位剤形中に1つ、1〜4つ、またはそれ以上の単位のmTORインヒビター(例えば、テムシロリムス)を、そして場合により、1つ、1〜4つ、またはそれ以上の単位のハーセプチン、そして場合により別の活性薬剤を有する1つまたはそれ以上の容器を含む、1個体の哺乳動物のための抗悪性腫瘍処置の治療単位を含有する生成物または医薬パックを含む。
投薬は、月1の日1に開始して、下に示される用量で、毎週、静脈内(IV)テムシロリムスおよびハーセプチン(IV)を用いる。
投薬は、月1の日1に開始して、下に示される用量で、毎日HKI−272および毎週、静脈内(IV)テムシロリムスを用いる。
投薬は、月1の日1に開始して、下に示される用量で、毎日HKI−272および毎週、静脈内(IV)テムシロリムスおよびハーセプチン(IV)を用いる。
ハーセプチンを加えたHKI−272の組み合わせの抗悪性腫瘍活性は、インビトロの標準的な薬学的な試験手順で確認される。以下は、用いられる手順および得られる結果を簡略に記載する。
Claims (44)
- 処置の必要な哺乳動物においてHER2の過剰発現または増幅に関連する新生物を処置する方法であって、ハーセプチンおよびmTORインヒビターおよび/またはHKI−272を含む活性成分の組み合わせの有効量を前記哺乳動物に提供することを含む、前記方法。
- 前記組み合わせがHKI−272を含む、請求項1に記載の方法。
- 前記1つまたはそれ以上の活性成分が、治療上有効な量以下で提供される、請求項1または2に記載の方法。
- 処置の必要な哺乳動物においてHER2の過剰発現または増幅に関連する新生物を処置する方法であって、ラパマイシンおよびHKI−272を含む組み合わせの有効量を前記哺乳動物に提供することを含む、前記方法。
- 前記新生物が、細気管支肺胞上皮癌および非小細胞肺癌を含む肺癌、乳癌、骨髄腫、前立腺癌、頭頸部癌、または移行上皮癌;子宮頸部の小細胞および大細胞の神経内分泌癌からなる群より選択される、請求項1から4のいずれか一項に記載の方法。
- 前記組み合わせが、1つまたはそれ以上の抗悪性腫瘍アルキル化剤、1つまたはそれ以上の代謝拮抗性抗悪性腫瘍剤、1つまたはそれ以上の生化学的免疫修飾剤、イマチニブ、1つまたはそれ以上のEGFRインヒビター、腫瘍細胞および腫瘍脈管構造の両方におけるセリン/トレオニンおよびレセプターチロシンキナーゼを標的にするマルチ−キナーゼインヒビター、またはインターフェロンからなる群より選択される別の活性成分をさらに含む、請求項1から5のいずれか一項に記載の方法。
- 前記抗悪性腫瘍剤が、メクロレタミン、シクロホスファミド、イフォスファミド、メルファラン、クロラムブシル、チオテパ、マイトマイシン、ブスルファン、ロムスチン、カルムスチン、プロカルバジン、テモゾロミド、オキサリプラチン、シスプラチンおよびカルボプラチンからなる群より選択される、請求項6に記載の方法。
- 前記代謝拮抗性抗悪性腫瘍剤が、5−フルオロウラシル;フロクスウリジン;チオグアニン;シタラビン;フルダラビン;6−メルカプトプリン;メトトレキサート;ゲムシタビン;カペシタビン;タキサン;ペントスタチン;トリメトレキサテール;およびクラドリビンからなる群より選択される、請求項7に記載の方法。
- 前記生化学的修飾剤が、ロイコボリンおよびレボホリナートからなる群より選択される、請求項7に記載の方法。
- 前記組み合わせがタキサンをさらに含む、請求項9に記載の方法。
- 前記ラパマイシンがラパマイシンである、請求項1から10のいずれか一項に記載の方法。
- 前記ラパマイシンが42−O−(2−ヒドロキシ)エチルラパマイシンである、請求項1から10のいずれか一項に記載の方法。
- 前記新生物が、転移性乳癌である、請求項1から12のいずれか一項に記載の方法。
- ハーセプチンを用いるレジメンで投与可能な抗悪性腫瘍医薬の調製におけるラパマイシンの使用、またはラパマイシンを用いるレジメンで投与可能な医薬の調製におけるハーセプチンの使用であって、前記レジメンが場合によりさらにHKI−272を含む、前記使用。
- HKI−272を用いるレジメンで投与可能な抗悪性腫瘍医薬の調製におけるラパマイシンの使用、またはラパマイシンを用いるレジメンで投与可能な医薬の調製におけるHKI−272の使用であって、前記レジメンが場合によりさらにハーセプチンを含む、前記使用。
- HKI−272を用いるレジメンで投与可能な抗悪性腫瘍医薬の調製におけるハーセプチンの使用、またはHKI−272を用いるレジメンで投与可能な医薬の調製におけるハーセプチンの使用であって、前記レジメンが場合によりさらにmTORインヒビターを含む、前記使用。
- 前記医薬が、細気管支肺胞上皮癌および非小細胞肺癌を含む肺癌、乳癌、骨髄腫、前立腺癌、頭頸部癌、または移行上皮癌;子宮頸部の小細胞および大細胞の神経内分泌癌からなる群より選択される、新生物の処置のためのものである、請求項14から16のいずれか一項に記載の使用。
- 前記ラパマイシンがラパマイシンである、請求項14から17のいずれか一項に記載の使用。
- 前記ラパマイシンが42−O−(2−ヒドロキシ)エチルラパマイシンである、請求項14から17のいずれか一項に記載の使用。
- 前記医薬が、転移性乳癌の処置のためのものである、請求項14から19のいずれか一項に記載の使用。
- HER2の過剰発現または増幅に関連する乳癌の処置のためのレジメンであって、前記方法は、
ハーセプチンのある投薬量を送達することと;
mTORインヒビターおよびHKI−272からなる群より選択される少なくとも1つのさらなる化合物のある用量を送達することとを含む、前記レジメン。 - ラパマイシンmTORインヒビターが静脈内に送達される、請求項21に記載のレジメン。
- 前記ラパマイシンが毎週送達される、請求項21に記載のレジメン。
- 前記ラパマイシンが経口的に送達される、請求項21に記載のレジメン。
- 前記ラパマイシンが毎週送達される、請求項21に記載のレジメン。
- 前記ハーセプチンが静脈内に送達される、請求項21に記載のレジメン。
- 前記ハーセプチンが少なくとも1週間のオフの後に少なくとも2週間送達される、請求項21に記載のレジメン。
- 前記ハーセプチンが4週間送達され、続いて2週間オフにされる、請求項21に記載のレジメン。
- 前記ハーセプチンが3〜4週間ごとに1回送達される、請求項21に記載のレジメン。
- 前記ラパマイシンがラパマイシンである、請求項21に記載のレジメン。
- 前記ラパマイシンがテムシロリムスである、請求項30に記載のレジメン。
- 前記HKI−272が経口的に送達される、請求項21に記載のレジメン。
- 哺乳動物において新生物の処置における同時、別々または連続的な使用のための併用製剤としてテムシロリムスおよびハーセプチンを含有する、生成物。
- 哺乳動物において新生物の処置における同時、別々または連続的な使用のための併用製剤としてラパマイシンおよびHKI−272を含有する、生成物。
- 哺乳動物において新生物の処置における同時、別々または連続的な使用のための併用製剤としてハーセプチンおよびHKI−272を含有する、生成物。
- 1個体の哺乳動物の抗悪性腫瘍処置の治療単位(course)を含有する医薬パックであって、前記パックが(a)少なくとも1単位のテムシロリムス、および(b)少なくとも1単位のハーセプチンを単位剤形に含有する、前記医薬パック。
- 1個体の哺乳動物の抗悪性腫瘍処置の治療単位を含有する医薬パックであって、前記パックが(a)少なくとも1単位のラパマイシン、および(b)少なくとも1単位のHKI−272を単位剤形に含有する、前記医薬パック。
- 1個体の哺乳動物の抗悪性腫瘍処置の治療単位を含有する医薬パックであって、前記パックが(a)少なくとも1単位のハーセプチン、および(b)少なくとも1単位のHKI−272を単位剤形に含有する、前記医薬パック。
- 哺乳動物における新生物を処置するのに有用な医薬組成物であって、前記組成物が(a)少なくとも1単位のテムシロリムス、および(b)少なくとも1単位のハーセプチンを単位剤形に含み、そして少なくとも1つの薬学的に許容可能なキャリアを含む、前記組成物。
- 哺乳動物における新生物を処置するのに有用な医薬組成物であって、前記組成物が(a)少なくとも1単位のラパマイシン、および(b)少なくとも1単位のHKI−272を単位剤形に含み、そして少なくとも1つの薬学的に許容可能なキャリアを含む、前記組成物。
- 哺乳動物における新生物を処置するのに有用な医薬組成物であって、前記組成物が(a)少なくとも1単位のハーセプチン、および(b)少なくとも1単位のHKI−272を単位剤形に含み、そして少なくとも1つの薬学的に許容可能なキャリアを含む、前記組成物。
- 式Aを有する化合物(請求項14に図示されかつ規定される)もしくはその薬学的に許容可能な塩を用いるレジメンで投与可能な抗悪性腫瘍医薬の調製におけるラパマイシンの使用、またはラパマイシンを用いるレジメンで投与可能な医薬の調製における式Aを有する化合物(請求項14に図示されかつ規定される)もしくはその薬学的に許容可能な塩の使用であって、前記レジメンが場合によりさらにハーセプチンを含む、前記使用。
- 式Aを有する化合物(請求項14に図示されかつ規定される)もしくはその薬学的に許容可能な塩を用いるレジメンで投与可能な抗悪性腫瘍医薬の調製におけるハーセプチンの使用、または式Aを有する化合物(請求項14に図示されかつ規定される)もしくはその薬学的に許容可能な塩を用いるレジメンで投与可能な医薬の調製におけるハーセプチンの使用であって、前記レジメンが場合によりさらにmTORインヒビターを含む、前記使用。
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JP2012179873A Active JP5952679B2 (ja) | 2005-11-04 | 2012-08-14 | mTORインヒビター、ハーセプチン、および/またはHKI−272の抗悪性腫瘍性組み合わせ |
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JP2015255873A Active JP6040303B2 (ja) | 2005-11-04 | 2015-12-28 | mTORインヒビター、ハーセプチン、および/またはHKI−272の抗悪性腫瘍性組み合わせ |
JP2016080252A Active JP6232463B2 (ja) | 2005-11-04 | 2016-04-13 | mTORインヒビター、ハーセプチン、および/またはHKI−272の抗悪性腫瘍性組み合わせ |
JP2017134635A Active JP6522056B2 (ja) | 2005-11-04 | 2017-07-10 | mTORインヒビター、ハーセプチン、および/またはHKI−272の抗悪性腫瘍性組み合わせ |
JP2018188726A Pending JP2018203783A (ja) | 2005-11-04 | 2018-10-04 | mTORインヒビター、ハーセプチン、および/またはHKI−272の抗悪性腫瘍性組み合わせ |
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