JP5465005B2 - マントル細胞リンパ腫治療のための3−(4−アミノ−1−オキソ−1,3−ジヒドロ−イソインドール−2−イル)−ピペリジン−2,6−ジオンの使用 - Google Patents
マントル細胞リンパ腫治療のための3−(4−アミノ−1−オキソ−1,3−ジヒドロ−イソインドール−2−イル)−ピペリジン−2,6−ジオンの使用 Download PDFInfo
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- JP5465005B2 JP5465005B2 JP2009522882A JP2009522882A JP5465005B2 JP 5465005 B2 JP5465005 B2 JP 5465005B2 JP 2009522882 A JP2009522882 A JP 2009522882A JP 2009522882 A JP2009522882 A JP 2009522882A JP 5465005 B2 JP5465005 B2 JP 5465005B2
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Description
本発明は、レナリドマイド、レブリミド(Revlimid)(登録商標)又はレビミド(Revimid)(登録商標)としても公知である化学名3-(4-アミノ-1-オキソ-1,3-ジヒドロ-イソインドール-2-イル)-ピペリジン-2,6-ジオンを有する免疫調節化合物を用いて、特定の種類のリンパ腫を治療、予防、又は管理する方法に関する。特に、本発明は、治療薬として化合物を単独で用いて、限定されないがマントル細胞リンパ腫(MCL)、中分化型のリンパ球性リンパ腫、中間型リンパ球性リンパ腫、ILL、びまん性低分化リンパ球性リンパ腫(diffuse poorly differentiated lymphocytic lymphoma)、PDL、中心細胞性リンパ腫、びまん性核切れ込み小細胞型リンパ腫、DSCCL、及びメントルゾーンリンパ腫などの非ホジキンリンパ腫を、治療、予防、又は管理する方法を包含する。
癌は、主に、特定の正常組織から誘導される異常細胞の数の増加、これらの異常細胞による隣接組織の浸潤、又は所属リンパ節及び遠隔部位への悪性細胞のリンパ性又は血行性伝播(転移)の増加によって特徴付けられる。臨床データ及び分子生物学的研究は、癌が、少数の新生物発生前の変化から始まる多段階過程であり、これが特定の条件下で新形成に進行し得ることを示している。新生物病変は、クローンとして進化し、特に新生細胞が宿主免疫監視を逃れる条件下において、浸潤、増殖、転移及び異種性のための能力の増加を生じ得る。Roitt, I.、Brostoff, J.及びKale, D.の文献、Immunology、17.1-17.12(第3版、Mosby, St. Louis, Mo., 1993)。
本発明は、原発性癌及び転移性癌、並びに再発性、難治性、又は従来の化学療法に抵抗性である癌を含めた、特定の種類のリンパ腫を治療、予防、又は管理する方法を包含する。特に、本発明の方法は、再発性、難治性、又は抵抗性のリンパ腫を含めた、マントル細胞リンパ腫、MCL、中分化型のリンパ球性リンパ腫、中間型リンパ球性リンパ腫、ILL、びまん性低分化リンパ球性リンパ腫、PDL、中心細胞リンパ腫、びまん性核切れ込み小細胞型リンパ腫、DSCCL、濾胞性リンパ腫及びメントルゾーンリンパ腫などの様々な形態のリンパ腫を治療、予防、又は管理する方法を包含する。
本発明の第1の実施態様は、特定の種類のリンパ腫を治療、管理、又は予防する方法であって、前記治療、管理、又は予防を必要とする患者に、治療的又は予防的有効量の本発明の免疫調節化合物又はその医薬として許容し得る塩、溶媒和物(例えば、水和物)、立体異性体、クラスレート又はプロドラッグを投与することを含む、前記方法を包含する。特に、本発明の方法は、限定されないが、マントル細胞リンパ腫、MCL、中分化型のリンパ球性リンパ腫、中間型リンパ球性リンパ腫、ILL、びまん性低分化リンパ球性リンパ腫、PDL、中心細胞性リンパ腫、びまん性核切れ込み小細胞型リンパ腫、DSCCL、濾胞性リンパ腫、及び顕微鏡で見ることができる任意の種類のマントル細胞リンパ腫(結節性、拡散性、芽細胞性、及びメントルゾーンリンパ腫)を含めた、リンパ腫の様々な形態を治療、予防、又は管理する方法を包含する。一実施態様において、リンパ腫は、難治性、再発性、又は本発明の免疫調節化合物以外の化学療法に抵抗性である。
本発明で使用される化合物は、ラセミ体、立体異性的に濃縮又は立体異性的に純粋である化合物を含む。いくつかの実施態様では、それらの医薬として許容し得る塩、溶媒和物(例えば、水和物)、クラスレート及びプロドラッグを含む。本発明に使用される好ましい化合物は、約1,000g/mol未満の分子量を有する小有機分子であり、タンパク質、ペプチド、オリゴヌクレオチド、オリゴ糖又は他の巨大分子ではない。
本発明の免疫調節化合物は、本発明の方法及び組成物において、他の薬理活性化合物(「第2の活性薬剤又は成分」)とともに用いる、又はそれらと組み合わせることができる。特定の組合せが、特定の種類のリンパ腫の治療において相乗的に働くと考えられる。本発明の免疫調節化合物は、特定の第2の活性薬剤に付随する有害作用を軽減するように働くことができ、いくつかの第2の活性薬剤は、本発明の免疫調節化合物に付随する有害作用を軽減するために使用することができる。
本発明の方法は、様々な種類のリンパ腫を治療、予防、又は管理する方法を包含する。好ましい実施態様において、本発明の方法は、限定されないがマントル細胞リンパ腫、MCL、中分化型のリンパ球性リンパ腫、中間型リンパ球性リンパ腫、ILL、びまん性低分化リンパ球性リンパ腫、PDL、中心細胞性リンパ腫、びまん性核切れ込み小細胞型リンパ腫、DSCCL、濾胞性リンパ腫、及び顕微鏡で見ることができる任意の種類のマントル細胞リンパ腫(結節性、拡散性、芽細胞性、及びメントルゾーンリンパ腫)を含めた、様々な種類のリンパ腫を治療、予防、又は管理する方法を包含する。
本発明の特定の方法は、一種以上の第2の活性薬剤と組み合わせて、及び/又は放射線療法、輸血又は手術と組み合わせて、本発明の免疫調節化合物又はその医薬として許容し得る塩、溶媒和物(例えば、水和物)、立体異性体、クラスレート又はプロドラッグを投与することを含む。本発明の免疫調節化合物の例は、本明細書中に開示されている(例えば、第4.1節を参照)。第2の活性薬剤の例も、本明細書中に開示されている(例えば、第4.2節を参照)。
本発明の化合物は、移植片対宿主病(GVHD)のリスクを減少させるために使用することができる。従って、本発明は、癌の治療、予防、及び/又は管理方法であって、移植療法と併用して、本発明の免疫調節化合物又はその医薬として許容し得る塩、溶媒和物(例えば、水和物)、立体異性体、クラスレート又はプロドラッグを投与することを含む方法を包含する。
ある実施態様において、本発明の予防薬又は治療薬は、患者に周期的に投与される。サイクリング療法は一時期の活性薬剤の投与、続いて一時期の休薬、及びこの経時的な投与の反復を含む。サイクリング療法により、1種以上の療法に対する耐性の発症を減少させること、療法の1つの副作用を回避し、若しくは減少させること、及び/又は治療の有効性を改善することができる。
医薬組成物は、個々の単回単位剤形の製剤で使用することができる。本発明の医薬組成物及び剤形は、本発明の免疫調節化合物又はその医薬として許容し得る塩、溶媒和物(例えば、水和物)、立体異性体、クラスレート又はプロドラッグを含む。本発明の医薬組成物及び剤形には、1種以上の賦形剤を更に含むことができる。
経口投与に適した本発明の医薬組成物は、錠剤(例えば、咀嚼錠)、カプレット、カプセル及び液体(例えば、風味をつけたシロップ)などの(しかし、限定されない)別々の剤形として提示することができる。この種の剤形は、予め定められた量の活性成分を含み、当業者に周知の薬学の方法によって製造することができる。一般的に、「レミントンの医科学(Remington 's Pharmaceutical Sciences)」, 第18版, Mack Publishing, Easton PA (1990)を参照されたい。
本発明の活性成分は、徐放手段によって、又は当業者に周知である送達装置によって投与することができる。例を挙げると、下記米国特許に記載されているものがあるが、これら限定されない:第3,845,770号;第3,916,899号;第3,536,809号;第3,598,123号;及び第4,008,719号、第5,674,533号、第5,059,595号、第5,591,767号、第5,120,548号、第5,073,543号、第5,639,476号、第5,354,556号、及び第5,733,566号である。その各々は引用により本明細書中に組み込まれている。例えば、比率を変化させて所望の放出プロフィールを提供するために、ハイドロプロピルメチルセルロース、その他のポリマーマトリクス、ゲル、浸透膜、浸透圧系、多層膜コーティング、微小粒子、リポソーム、微粒子、又はそれらの組合せなどを用いて、1種以上の活性成分の緩徐放出又は徐放を提供するように、前記剤形を使用することができる。本明細書中に記述したものを含む当業者に公知の適切な徐放性製剤は、本発明の活性成分の用途にあわせて容易に選択することができる。従って、本発明は、限定されないが、徐放性に適合された錠剤、カプセル、ジェルキャップ及びカプレットなどの経口投与用の単回単位剤形を包含する。
非経口剤形は、患者に対して皮下、静脈内(大量瞬時投与を含む)、筋肉内及び動脈内などの限定されない種々の経路によって投与することができる。これらの投与は、典型的には混入物に対する患者の天然の防御を迂回するので、非経口剤形は、好ましくは無菌であるか、又は患者に対して投与の前に滅菌することができる。非経口剤形の例には、注射用に準備された溶液、注射用の医薬として許容し得る媒体に溶解若しくは懸濁する準備済乾燥製品、注射用に準備された懸濁液、及び乳剤を含むが、これらに限定されない。
本発明の特定の実施態様は、以下の非制限的実施例によって例示される。
(5.1.1 マントル細胞リンパ腫の治療)
最大耐量(MTD)を測定し、かつ再発性又は難治性マントル細胞リンパ腫(MCL)に対する、リツキシマブと組み合わせた3-(4-アミノ-1-オキソ-1,3-ジヒドロ-イソインドール-2-イル)-ピペリジン-2,6-ジオン(レナリドマイド又はレブリミド(登録商標))の有効性を評価するために、単一施設(非盲検)第1相/第2相研究を行った。従来の1〜4ライン治療中の患者が適格であった。抵抗性に関係なく、従来のサリドマイド又はリツキシマブを用いて治療中の患者が適格であった。治療の各サイクル(28日)は、21日間毎日経口的に与えられる3-(4-アミノ-1-オキソ-1,3-ジヒドロ-イソインドール-2-イル)-ピペリジン-2,6-ジオン(レブリミド(登録商標))の投与、続いて7日間の休薬、及び4週間毎週の静脈注射による375mg/m2のリツキシマブの投与により構成した。レブリミド(登録商標)10mg、15mg、20mg及び25mgの用量レベルでMTDを測定するために、標準的な第一相の段階的用量増加を使用した。用量規定毒性(DLT)は、第1サイクル期間中の、グレード3又は4の非血液毒性、又はグレード4の血液毒性として定義した。
再発性又は難治性の侵襲性非ホジキンリンパ腫(NHL)患者において、多施設(非盲検)第2相研究を行った。試験は、再発性及び難治性の侵襲性NHL患者40人において、測定可能な疾患(measurable disease)の1つ以上の事前治療計画の後に、3-(4-アミノ-1-オキソ-1,3-ジヒドロ-イソインドール-2-イル)-ピペリジン-2,6-ジオン(レブリミド(登録商標)又はレナリドマイド)を用いた経口単独療法の治療可能性及び安全性を評価するように計画した。28日のサイクルにおいて、1日〜21日の間で、該研究の患者に25mgの量のレナリドマイドを1日1回経口投与し、52週間、再発又は疾患が進行するまで療法を継続した。
Claims (15)
- 3-(4-アミノ-1-オキソ-1,3-ジヒドロ-イソインドール-2-イル)-ピペリジン-2,6-ジオン又はその医薬として許容し得る塩若しくは溶媒和物を含む、マントル細胞リンパ腫を治療するための医薬組成物であって、3-(4-アミノ-1-オキソ-1,3-ジヒドロ-イソインドール-2-イル)-ピペリジン-2,6-ジオンが、1〜50mg/日の量で投与され、かつ一サイクルにおいて、一時期投与され、その後一時期休薬されるように用いられることを特徴とする、前記医薬組成物。
- 前記マントル細胞リンパ腫が、再発性、難治性、又は従来の療法に抵抗性である、請求項1記載の医薬組成物。
- 3-(4-アミノ-1-オキソ-1,3-ジヒドロ-イソインドール-2-イル)-ピペリジン-2,6-ジオンが、5〜25mg/日の量で投与されるように用いられることを特徴とする、請求項1又は2記載の医薬組成物。
- 3-(4-アミノ-1-オキソ-1,3-ジヒドロ-イソインドール-2-イル)-ピペリジン-2,6-ジオンが、5、10、15、20及び25mg/日から選択される量で投与されるように用いられることを特徴とする、請求項3記載の医薬組成物。
- 3-(4-アミノ-1-オキソ-1,3-ジヒドロ-イソインドール-2-イル)-ピペリジン-2,6-ジオンが、25mg/日の量で投与されるように用いられることを特徴とする、請求項4記載の医薬組成物。
- 経口投与用に製剤されている、請求項1記載の医薬組成物。
- カプセル又は錠剤の形態である、請求項6記載の医薬組成物。
- 3-(4-アミノ-1-オキソ-1,3-ジヒドロ-イソインドール-2-イル)-ピペリジン-2,6-ジオンが、28日のサイクルにおいて、21日間投与され、続いて7日間休薬されるように用いられることを特徴とする、請求項1記載の医薬組成物。
- 3-(4-アミノ-1-オキソ-1,3-ジヒドロ-イソインドール-2-イル)-ピペリジン-2,6-ジオンが、28日のサイクルにおいて、25mg/日の量で21日間投与され、続いて7日間休薬されるように用いられることを特徴とする、請求項8記載の医薬組成物。
- 3-(4-アミノ-1-オキソ-1,3-ジヒドロ-イソインドール-2-イル)-ピペリジン-2,6-ジオンとともに又は別々に、リツキシマブが毎週静脈内注射によって375mg/m2の量で投与されるように用いられることを特徴とする、請求項9記載の医薬組成物。
- 1〜50mgの量の3-(4-アミノ-1-オキソ-1,3-ジヒドロ-イソインドール-2-イル)-ピペリジン-2,6-ジオン又はその医薬として許容し得る塩若しくは溶媒和物を含む、マントル細胞リンパ腫を治療するための医薬組成物であって、3-(4-アミノ-1-オキソ-1,3-ジヒドロ-イソインドール-2-イル)-ピペリジン-2,6-ジオンとともに又は別々に、第2の活性薬剤が投与されるように用いられることを特徴とする、前記医薬組成物。
- 5〜25mgの量の3-(4-アミノ-1-オキソ-1,3-ジヒドロ-イソインドール-2-イル)-ピペリジン-2,6-ジオン又はその医薬として許容し得る塩若しくは溶媒和物を含む、請求項11記載の医薬組成物。
- 3-(4-アミノ-1-オキソ-1,3-ジヒドロ-イソインドール-2-イル)-ピペリジン-2,6-ジオンが、一サイクルにおいて、一時期投与され、その後一時期休薬されるように用いられることを特徴とする、請求項11記載の医薬組成物。
- 前記第2の活性薬剤が、抗体、造血成長因子、サイトカイン、抗癌剤、抗生物質、cox-2阻害剤、免疫調節剤、免疫抑制剤、コルチコステロイド又は薬理活性変異体、或いはそれらの誘導体である、請求項11記載の医薬組成物。
- 前記第2の活性薬剤が、リツキシマブである、請求項11記載の医薬組成物。
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CL2004001004A1 (es) * | 2003-05-19 | 2005-03-18 | Upjohn Co | Combinacion farmaceutica que comprende irinotecan y revimid para tratar el mieloma multiple. |
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Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
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JP2013256514A (ja) * | 2006-08-03 | 2013-12-26 | Celgene Corp | マントル細胞リンパ腫治療のための3−(4−アミノ−1−オキソ−1,3−ジヒドロ−イソインドール−2−イル)−ピペリジン−2,6−ジオンの使用 |
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