JP2022527702A - 小細胞肺がんの治療におけるキアウラニブの使用 - Google Patents
小細胞肺がんの治療におけるキアウラニブの使用 Download PDFInfo
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- JP2022527702A JP2022527702A JP2021556944A JP2021556944A JP2022527702A JP 2022527702 A JP2022527702 A JP 2022527702A JP 2021556944 A JP2021556944 A JP 2021556944A JP 2021556944 A JP2021556944 A JP 2021556944A JP 2022527702 A JP2022527702 A JP 2022527702A
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- chiauranib
- small cell
- lung cancer
- cell lung
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Abstract
Description
本願は、発明の名称が「小細胞肺がんの治療におけるキアウラニブの使用」である、2019年3月25日に中国特許庁へ提出された中国特許出願201910229379.6に基づく優先権を主張し、その全内容は、全体として援用により本明細書に組み込まれる。
1.非小細胞肺がん、結腸・直腸癌、卵巣癌、腎細胞がん、消化管間質腫瘍、胃癌などを含む、組織学や細胞学によって明確に診断された進行固形悪性腫瘍の患者;
2.標準レジメン治療が失敗した、或いは、標準治療レジメンが欠如した患者;
3.ボディマス指数が18~28の範囲にあること;
4.年齢:18~65歳、性別制限なし;
5.ECOGスコア:0または1ポイント;
6.主要臓器の機能は以下の基準を満たすこと:
a)血液一般検査:ヘモグロビン(Hb)≧100g/L(14日以内に輸血なし);好中球絶対数(ANC)≧1.5×109/L;血小板(PLT)≧100×109/L;
b)生化学検査:血清クレアチニンCr≦正常値上限(ULN);ビリルビンBIL≦1.25×ULN;アラニンアミノトランスフェラーゼ(ALT)、アスパラギン酸アミノトランスフェラーゼ(AST)≦1.5×ULN;空腹時トリグリセリド(TG)≦3.0mmol/L,空腹時総コレステロール(TC)≦7.75mmol/L;
c)血液凝固機能:国際標準化比(INR)<1.5。
7.女性は、研究期間中および研究終了後からの6か月以内に避妊手段を使用する必要があり、グループに参加した前の7日以内に血清や尿による妊娠検査が陰性であり、非授乳期の患者であること、男性は、研究期間中及び終了後からの6か月以内避妊手段を使用する必要があること;
8.書面によるインフォームド・コンセントに自発的に署名すること。
毎日1回、空腹時に、所定用量のキアウラニブカプセルを経口服用させ、28日を1治療サイクルとした。グループに参加したすべての患者が、治療サイクル中に休薬期間がなく、疾患が進行したか耐えられない毒性が現れたまで試験薬治療を受けた。
試験グループに参加した患者が合計18名であり、すべてFAS、SS及びPPSの分析セットに含まれていた。18名の患者は、7名が(38.9%)結腸・直腸癌であり、5名(27.8%)が非小細胞肺がんであり、また、胃癌、卵巣癌、甲状腺乳頭癌、びまん性大細胞型B細胞リンパ腫、線維肉腫、低分化型腎癌がそれぞれ1名であった。
実施例2:再発・難治性小細胞肺がんのキアウラニブ単独治療の第Ib相の臨床試験
1.18歳以上75歳以下、性別制限なし;
2.組織学や細胞学によって確認された小細胞肺がん;
3.過去に少なくとも2つの異なる全身化学療法レジメン(プラチナ含有化学療法レジメンを含んだ)を受けたことがあり、その後、疾患が進行または再発したこと;
4.RECIST1.1標準によると、少なくとも1つの測定可能な標的病変があり、ただし、放射線療法または局所領域治療によって治療された病変は、標的病変と見なされる前に、疾患進行の画像検査による証拠を持つ必要があること;
5.ECOGフィットネススコアが0-1ポイントにあること;
6.主要臓器の機能は以下の基準を満たすこと:
a)血液一般検査:好中球絶対数≧1.5×109/L、血小板≧75×109/L、ヘモグロビン≧80g/L
b)血液生化学検査:総ビリルビン≦正常値上限の1.5倍、AST/ALT≦正常値上限の2.5倍(肝転移の場合、正常値上限の5倍以下)、血清クレアチニン≦正常値上限の1.5倍;
血液凝固機能:プロトロンビン時間-国際標準化比(PT-INR)<1.5。
7.予想生存期間≧3ヶ月;
8.書面によるインフォームド・コンセントに自発的に署名すること。
試験対象に毎日1回、空腹時に、キアウラニブカプセル50mgを経口服用させ、28日を1治療サイクルとし、また、治療サイクル中に休薬期間がない。試験期間にわたって、すべての被験者は、疾患の進行、耐えられない毒性反応、死亡、インフォームド・コンセントの撤回、またはフォローアップの喪失のいずれか(最初に発生したほう)が発生するまで、治療を続けた。
段階的にグループに参加した小細胞肺がん患者が25名であり、ただし、治療効果評価した患者が20名であった。その結果、4名の患者は、最良の治療効果の評価がPRであり、客観的奏効率(ORR)が20%であった。これらの結果は、キアウラニブが小細胞肺がんを効果的に治療することができることを示している。
実施例3:他の腫瘍および小細胞肺がんに対するキアウラニブ治療の効果の比較
Claims (4)
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CN201910229379.6 | 2019-03-25 | ||
PCT/CN2020/079822 WO2020192506A1 (zh) | 2019-03-25 | 2020-03-18 | 西奥罗尼用于小细胞肺癌的治疗 |
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