JP6734971B2 - がん治療薬 - Google Patents
がん治療薬 Download PDFInfo
- Publication number
- JP6734971B2 JP6734971B2 JP2019114783A JP2019114783A JP6734971B2 JP 6734971 B2 JP6734971 B2 JP 6734971B2 JP 2019114783 A JP2019114783 A JP 2019114783A JP 2019114783 A JP2019114783 A JP 2019114783A JP 6734971 B2 JP6734971 B2 JP 6734971B2
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- JP
- Japan
- Prior art keywords
- cancer
- acid
- jph203
- injection
- cyclodextrin
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Classifications
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- 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
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/42—Oxazoles
- A61K31/423—Oxazoles condensed with carbocyclic rings
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- 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
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Dermatology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Heterocyclic Carbon Compounds Containing A Hetero Ring Having Nitrogen And Oxygen As The Only Ring Hetero Atoms (AREA)
- Medicinal Preparation (AREA)
Description
[2]JPH203又はその薬理学的に許容される塩及び医薬品添加物含む、がん治療用医薬組成物であって、がんが胆道がん、大腸がん、食道がん、乳がん又は膵がんである、がん治療用医薬組成物。
[3]JPH203又はその薬理学的に許容される塩を、それを必要とする患者に投与することを含む、がんを治療する方法であって、がんが胆道がん、大腸がん、食道がん、乳がん又は膵がんである、がん治療方法。
[4]がん治療のためのJPH203又はその薬理学的に許容される塩であって、がんが胆道がん、大腸がん、食道がん、乳がん又は膵がんである、JPH203又はその薬理学的に許容される塩。
[5]がん治療薬の製造のためのJPH203又はその薬理学的に許容される塩の使用であって、がんが胆道がん、大腸がん、食道がん、乳がん又は膵がんである、使用。
[6]JPH203又はその薬理学的に許容される塩が1回1mg/m2〜60mg/m2で投与される、上記[1]〜[5]のがん治療薬、がん治療用医薬組成物、がん治療方法、化合物又は使用。
注射剤は凍結乾燥製剤で、1バイアル中に50mgのJPH203及び1200mgのスルホブチルエーテル−β−シクロデキストリンを含有する。
本臨床試験は、固形がんを有する患者を対象とした。本臨床試験の目的は、JPH203の安全性(用量制限毒性:DLT)及び有効性を評価することにある。
選択基準
・固形がんを有することが確認されていて、標準的治療が無効又は不耐の状態にある進行期の患者
・LAT1抗体染色のための生検又は既存組織の利用が可能な患者
・登録日から90日以上の生存が期待できる患者
除外基準
・重篤又は臨床上問題ある既往症、合併症を有する患者
・治験薬投与前4週間以内に化学療法、放射線療法、免疫療法、その他腫瘍縮小効果を目的とした療法を受けた患者
1)単回投与
1日目に、所定の投与量を単回投与した。投与量は、12mg/m2(4例)、25mg/m2(3例)、40mg/m2(3例)、60mg/m2(6例)又は85mg/m2(1例)である。12mg/m2投与群のうち1例は、病勢進行のため単回投与のみで中止した。
2)サイクル1
単回投与の投与から8日以降にサイクル1を開始し、1日1回、7日間連続投与した。サイクル1の投与開始日から28〜31日目にCT等の検査を行った。
3)サイクル2以降
前サイクルの検査日から28日以内に、次サイクルを開始し、1日1回、7日間連続投与した。投与開始日から28〜31日目に検査を行った。
1)Grade3以上で治験責任(分担)医師が治験薬の継続投与が困難と判断した非血液毒性(ただし、Grade3のざ瘡様皮疹、斑状丘疹状皮疹、蕁麻疹及び対症療法により発生後7日以内にGrade1に回復する悪心、嘔吐、食欲不振、下痢、便秘、疲労を除く)
2)Grade4以上の血液毒性又は輸血を必要とするGrade3以上の血小板減少
3)発熱性好中球減少症
60mg/m2投与群及び85mg/m2投与群において、Grade3のAST/ALT上昇が認められた。
腫瘍の大きさが30%以上減少した例(部分奏効:PR)は12mg/m2投与群に1例あり、腫瘍の大きさが変化しない例(安定:SD)は12mg/m2投与群、25mg/m2投与群、40mg/m2投与群及び60mg/m2投与群に1例ずつあった。また、リンパ節転移病変において顕著な縮小効果が7例中3例にあった(55%、69.4%、80%縮小)。
Claims (2)
- O−(5−アミノ−2−フェニルベンズオキサゾール−7−イル)メチル−3,5−ジクロロ−L−チロシン又はその薬理学的に許容される塩を含む、標準的治療が無効又は不耐の状態にある進行期の胆道がん患者のための胆道がん治療薬。
- 1回12mg/m2〜25mg/m2のO−(5−アミノ−2−フェニルベンズオキサゾール−7−イル)メチル−3,5−ジクロロ−L−チロシン又はその薬理学的に許容される塩が投与される、請求項1に記載の胆道がん治療薬。
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP2017253385 | 2017-12-28 | ||
JP2017253385 | 2017-12-28 |
Related Parent Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2019503591A Division JP6546367B1 (ja) | 2017-12-28 | 2018-08-01 | がん治療薬 |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2020017875A Division JP2020073586A (ja) | 2017-12-28 | 2020-02-05 | がん治療薬 |
Publications (2)
Publication Number | Publication Date |
---|---|
JP2019151672A JP2019151672A (ja) | 2019-09-12 |
JP6734971B2 true JP6734971B2 (ja) | 2020-08-05 |
Family
ID=67066788
Family Applications (4)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2019503591A Active JP6546367B1 (ja) | 2017-12-28 | 2018-08-01 | がん治療薬 |
JP2019114783A Active JP6734971B2 (ja) | 2017-12-28 | 2019-06-20 | がん治療薬 |
JP2020017875A Pending JP2020073586A (ja) | 2017-12-28 | 2020-02-05 | がん治療薬 |
JP2023089646A Pending JP2023101705A (ja) | 2017-12-28 | 2023-05-31 | がん治療薬 |
Family Applications Before (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2019503591A Active JP6546367B1 (ja) | 2017-12-28 | 2018-08-01 | がん治療薬 |
Family Applications After (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2020017875A Pending JP2020073586A (ja) | 2017-12-28 | 2020-02-05 | がん治療薬 |
JP2023089646A Pending JP2023101705A (ja) | 2017-12-28 | 2023-05-31 | がん治療薬 |
Country Status (10)
Country | Link |
---|---|
US (1) | US20200405695A1 (ja) |
EP (1) | EP3733175B1 (ja) |
JP (4) | JP6546367B1 (ja) |
KR (1) | KR102377742B1 (ja) |
CN (1) | CN111491632A (ja) |
BR (1) | BR112020012766A2 (ja) |
CA (1) | CA3083343C (ja) |
ES (1) | ES2960392T3 (ja) |
MX (1) | MX2020006678A (ja) |
WO (1) | WO2019130637A1 (ja) |
Families Citing this family (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US11899019B2 (en) * | 2017-11-07 | 2024-02-13 | J-Pharma Co., Ltd. | Method for predicting efficacy of anti-PD-1 antibody or anti-PD-L1 antibody therapy, method for evaluating cancer grade, and method for enhancing efficacy of anti-PD-1 antibody or anti-PD-L1 antibody therapy |
CA3140042A1 (en) | 2019-05-14 | 2020-11-19 | Tyme, Inc. | Compositions and methods for treating cancer |
CN112336859A (zh) * | 2019-08-06 | 2021-02-09 | 上海绿谷制药有限公司 | 通过抑制t细胞摄取氨基酸治疗阿尔茨海默病的方法 |
CA3167918A1 (en) * | 2020-01-17 | 2021-07-22 | Tyme, Inc. | Compositions and methods for modulating cancer |
US10905698B1 (en) | 2020-05-14 | 2021-02-02 | Tyme, Inc. | Methods of treating SARS-COV-2 infections |
WO2022102687A1 (ja) * | 2020-11-11 | 2022-05-19 | ジェイファーマ株式会社 | がん治療剤 |
Family Cites Families (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPWO2008081537A1 (ja) * | 2006-12-28 | 2010-04-30 | 株式会社ヒューマンセルシステムズ | Lat1阻害活性を有する芳香族アミノ酸誘導体、それを含有するlat1阻害活性剤及びその製造方法 |
KR20170001962A (ko) * | 2014-05-15 | 2017-01-06 | 제이 파마 가부시끼가이샤 | 항 악성 종양제 조성물 |
JP2017155023A (ja) * | 2016-03-04 | 2017-09-07 | ジェイファーマ株式会社 | Lat1阻害活性を有する芳香族アミノ酸誘導体を含有する注射剤 |
US11899019B2 (en) * | 2017-11-07 | 2024-02-13 | J-Pharma Co., Ltd. | Method for predicting efficacy of anti-PD-1 antibody or anti-PD-L1 antibody therapy, method for evaluating cancer grade, and method for enhancing efficacy of anti-PD-1 antibody or anti-PD-L1 antibody therapy |
WO2021040042A1 (ja) * | 2019-08-30 | 2021-03-04 | ジェイファーマ株式会社 | 特定の遺伝子マーカーを有する患者に用いるがん治療用の医薬組成物 |
WO2022102687A1 (ja) * | 2020-11-11 | 2022-05-19 | ジェイファーマ株式会社 | がん治療剤 |
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2018
- 2018-08-01 CA CA3083343A patent/CA3083343C/en active Active
- 2018-08-01 CN CN201880082290.5A patent/CN111491632A/zh active Pending
- 2018-08-01 KR KR1020207021029A patent/KR102377742B1/ko active IP Right Grant
- 2018-08-01 BR BR112020012766-3A patent/BR112020012766A2/pt active Search and Examination
- 2018-08-01 EP EP18894766.7A patent/EP3733175B1/en active Active
- 2018-08-01 US US16/957,293 patent/US20200405695A1/en active Pending
- 2018-08-01 WO PCT/JP2018/028887 patent/WO2019130637A1/ja unknown
- 2018-08-01 ES ES18894766T patent/ES2960392T3/es active Active
- 2018-08-01 JP JP2019503591A patent/JP6546367B1/ja active Active
- 2018-08-01 MX MX2020006678A patent/MX2020006678A/es unknown
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2019
- 2019-06-20 JP JP2019114783A patent/JP6734971B2/ja active Active
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2020
- 2020-02-05 JP JP2020017875A patent/JP2020073586A/ja active Pending
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2023
- 2023-05-31 JP JP2023089646A patent/JP2023101705A/ja active Pending
Also Published As
Publication number | Publication date |
---|---|
JP6546367B1 (ja) | 2019-07-17 |
CN111491632A (zh) | 2020-08-04 |
EP3733175B1 (en) | 2023-10-04 |
CA3083343C (en) | 2022-04-26 |
JP2020073586A (ja) | 2020-05-14 |
JP2019151672A (ja) | 2019-09-12 |
MX2020006678A (es) | 2020-08-31 |
ES2960392T3 (es) | 2024-03-04 |
EP3733175A4 (en) | 2021-08-18 |
KR102377742B1 (ko) | 2022-03-22 |
BR112020012766A2 (pt) | 2020-12-01 |
CA3083343A1 (en) | 2019-07-04 |
US20200405695A1 (en) | 2020-12-31 |
KR20200101960A (ko) | 2020-08-28 |
JP2023101705A (ja) | 2023-07-21 |
WO2019130637A1 (ja) | 2019-07-04 |
EP3733175A1 (en) | 2020-11-04 |
JPWO2019130637A1 (ja) | 2019-12-26 |
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