IL320004A - Methods for treating estrogen receptor-mediated disorders - Google Patents

Methods for treating estrogen receptor-mediated disorders

Info

Publication number
IL320004A
IL320004A IL320004A IL32000425A IL320004A IL 320004 A IL320004 A IL 320004A IL 320004 A IL320004 A IL 320004A IL 32000425 A IL32000425 A IL 32000425A IL 320004 A IL320004 A IL 320004A
Authority
IL
Israel
Prior art keywords
compound
kit
pharmaceutically acceptable
acceptable salt
cancer
Prior art date
Application number
IL320004A
Other languages
Hebrew (he)
Inventor
Pamela M Klein
Original Assignee
Olema Pharmaceuticals Inc
Novartis Ag
Pamela M Klein
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Olema Pharmaceuticals Inc, Novartis Ag, Pamela M Klein filed Critical Olema Pharmaceuticals Inc
Publication of IL320004A publication Critical patent/IL320004A/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/4353Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems
    • A61K31/437Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems the heterocyclic ring system containing a five-membered ring having nitrogen as a ring hetero atom, e.g. indolizine, beta-carboline
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • A61P35/04Antineoplastic agents specific for metastasis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00

Landscapes

  • Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oncology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

Claims (32)

Claims
1. A method of treating an estrogen receptor mediated disease, disorder, or condition in a subject comprising administering a composition comprising Compound or a pharmaceutically acceptable salt thereof, wherein Compound 1 is administered in an amount that is about 15 mg to about 360 mg, in combination with a composition comprising about 200 to about 800 mg of ribociclib, or a pharmaceutically acceptable salt thereof.
2. The method of claim 1, wherein Compound 1 is administered in an amount that is about 30 mg to about 120 mg.
3. The method of claim 1 or 2, wherein Compound 1 is administered in an amount that is about 30 mg.
4. The method of claim 1 or 2, wherein Compound 1 is administered in an amount that is about 60 mg.
5. The method of claim 1 or 2, wherein Compound 1 is administered in an amount that is about 90 mg.
6. The method of claim 1 or 2, wherein Compound 1 is administered in an amount that is about 120 mg.
7. The method of any one of claims 1-6, wherein ribociclib is administered in an amount that is about 500 to about 700 mg.
8. The method of any one of claims 1-7, wherein ribociclib is administered in an amount that is about 600 mg.
9. The method of any one of claims 1-8, wherein Compound 1 is administered once daily.
10. The method of any one of claims 1-8, wherein ribociclib is administered once daily for 21 days, followed by a 7-day dose holiday.
11. The method of any one of claims 1-10, wherein Compound 1 and ribociclib are administered concomitantly.
12. The method of any one of claims 1-11, wherein the composition comprising Compound 1 or a pharmaceutically acceptable salt thereof is a capsule or a tablet.
13. The method of claim 12, wherein the composition comprising ribociclib or a pharmaceutically acceptable salt thereof is a capsule or a tablet.
14. The method of any one of claims 1-13, wherein the estrogen receptor-mediated disease, disorder, or condition is a cancer.
15. The method of claim 14, wherein the cancer is breast cancer.
16. The method of claim 15, wherein the cancer is HR+/HER2- breast cancer.
17. The method of any one of claims 14-16, wherein the cancer has metastasized to another organ.
18. The method of claim 17, wherein the cancer has metastasized to the brain, bone, lungs, or liver.
19. The method of any one of claims 1-18, wherein the subject has previously received at least one of a CDK4/6 inhibitor, an aromatase inhibitor, chemotherapy, fulvestrant, or a combination thereof.
20. In a method of treating a disease, disorder, or condition comprising administering Compound , or a pharmaceutically acceptable salt thereof, and ribociclib in combination, the improvement comprising administering from about 30 mg to about 120 mg Compound 1, or a pharmaceutically acceptable salt thereof, and about 600 mg of ribociclib, or a pharmaceutically acceptable salt thereof.
21. A kit comprising a composition comprising about 30 mg to about 360 mg of Compound 1 or a pharmaceutically acceptable salt thereof, and a composition comprising about 200 to about 800 mg of ribociclib, or a pharmaceutically acceptable salt thereof.
22. The kit of claim 21, wherein the kit comprises about 30 mg of Compound 1, or a pharmaceutically acceptable salt thereof.
23. The kit of claim 21, wherein the kit comprises about 60 mg of Compound 1, or a pharmaceutically acceptable salt thereof.
24. The kit of claim 21, wherein the kit comprises about 90 mg of Compound 1, or a pharmaceutically acceptable salt thereof.
25. The kit of claim 21, wherein the kit comprises about 120 mg of Compound 1, or a pharmaceutically acceptable salt thereof.
26. The kit of any one of claims 21-25, wherein the kit comprises about 600 mg of ribociclib, or a pharmaceutically acceptable salt thereof.
27. The kit of any one of claims 21-26, wherein the kit further comprises packaging material that comprises a label which indicates that Compound 1 and ribociclib can be used for treating an estrogen-receptor mediated disease, disorder, or condition.
28. The kit of claim 27, wherein the estrogen receptor-mediated disease, disorder, or condition is a cancer.
29. The kit of claim 28, wherein the cancer is breast cancer.
30. The kit of claim 29, wherein the cancer is HR+/HER2- breast cancer.
31. The kit of any one of claims 28-30, wherein the cancer has metastasized to another organ.
32. The kit of claim 31, wherein the cancer has metastasized to the brain, bone, lungs, or liver. For the Applicant WOLFF, BREGMAN AND GOLLER By:
IL320004A 2022-10-05 2023-10-04 Methods for treating estrogen receptor-mediated disorders IL320004A (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202263413475P 2022-10-05 2022-10-05
PCT/US2023/034454 WO2024076626A1 (en) 2022-10-05 2023-10-04 Methods of treating estrogen receptor-mediated disorders

Publications (1)

Publication Number Publication Date
IL320004A true IL320004A (en) 2025-06-01

Family

ID=90608897

Family Applications (1)

Application Number Title Priority Date Filing Date
IL320004A IL320004A (en) 2022-10-05 2023-10-04 Methods for treating estrogen receptor-mediated disorders

Country Status (8)

Country Link
EP (1) EP4598520A1 (en)
JP (1) JP2025533900A (en)
KR (1) KR20250095627A (en)
CN (1) CN120187424A (en)
AU (1) AU2023356291A1 (en)
IL (1) IL320004A (en)
MX (1) MX2025004050A (en)
WO (1) WO2024076626A1 (en)

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2010138659A1 (en) * 2009-05-27 2010-12-02 Ptc Therapeutics, Inc. Methods for treating brain tumors
EP2434891B9 (en) * 2009-05-27 2021-05-05 PTC Therapeutics, Inc. Methods for treating cancer and non-neoplastic conditions
EP3355884B1 (en) * 2015-10-01 2021-04-28 Olema Pharmaceuticals, Inc. TETRAHYDRO-1H-PYRIDO[3,4-b]INDOLE ANTI-ESTROGENIC DRUGS
CN113490850B (en) * 2018-08-17 2024-12-06 基因泰克公司 Diagnostic and therapeutic approaches used to treat breast cancer
WO2021178846A1 (en) * 2020-03-06 2021-09-10 Olema Pharmaceuticals, Inc. Methods of treating estrogen receptor-associated diseases

Also Published As

Publication number Publication date
CN120187424A (en) 2025-06-20
MX2025004050A (en) 2025-05-02
EP4598520A1 (en) 2025-08-13
AU2023356291A1 (en) 2025-04-17
JP2025533900A (en) 2025-10-09
KR20250095627A (en) 2025-06-26
WO2024076626A1 (en) 2024-04-11

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