NZ739270B2 - Therapeutic combinations of orally administered paclitaxel and a p-gp inhibitor for the treatment of cancer - Google Patents
Therapeutic combinations of orally administered paclitaxel and a p-gp inhibitor for the treatment of cancer Download PDFInfo
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- NZ739270B2 NZ739270B2 NZ739270A NZ73927016A NZ739270B2 NZ 739270 B2 NZ739270 B2 NZ 739270B2 NZ 739270 A NZ739270 A NZ 739270A NZ 73927016 A NZ73927016 A NZ 73927016A NZ 739270 B2 NZ739270 B2 NZ 739270B2
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- New Zealand
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- paclitaxel
- cancer
- auc
- administered
- amount
- Prior art date
Links
- 229930012538 Paclitaxel Natural products 0.000 title claims abstract 71
- 229960001592 paclitaxel Drugs 0.000 title claims abstract 71
- RCINICONZNJXQF-MZXODVADSA-N taxol Chemical compound O([C@@H]1[C@@]2(C[C@@H](C(C)=C(C2(C)C)[C@H](C([C@]2(C)[C@@H](O)C[C@H]3OC[C@]3([C@H]21)OC(C)=O)=O)OC(=O)C)OC(=O)[C@H](O)[C@@H](NC(=O)C=1C=CC=CC=1)C=1C=CC=CC=1)O)C(=O)C1=CC=CC=C1 RCINICONZNJXQF-MZXODVADSA-N 0.000 title claims abstract 71
- 206010028980 Neoplasm Diseases 0.000 title claims abstract 15
- 201000011510 cancer Diseases 0.000 title claims abstract 14
- 230000001225 therapeutic effect Effects 0.000 title claims 2
- 239000003112 inhibitor Substances 0.000 title abstract 2
- 238000002560 therapeutic procedure Methods 0.000 claims abstract 3
- 206010020751 Hypersensitivity Diseases 0.000 claims abstract 2
- 208000026935 allergic disease Diseases 0.000 claims abstract 2
- 238000006243 chemical reaction Methods 0.000 claims abstract 2
- 238000001802 infusion Methods 0.000 claims abstract 2
- 239000008389 polyethoxylated castor oil Substances 0.000 claims abstract 2
- 229940126062 Compound A Drugs 0.000 claims 12
- NLDMNSXOCDLTTB-UHFFFAOYSA-N Heterophylliin A Natural products O1C2COC(=O)C3=CC(O)=C(O)C(O)=C3C3=C(O)C(O)=C(O)C=C3C(=O)OC2C(OC(=O)C=2C=C(O)C(O)=C(O)C=2)C(O)C1OC(=O)C1=CC(O)=C(O)C(O)=C1 NLDMNSXOCDLTTB-UHFFFAOYSA-N 0.000 claims 12
- 239000003814 drug Substances 0.000 claims 7
- 150000001875 compounds Chemical class 0.000 claims 6
- 208000030507 AIDS Diseases 0.000 claims 5
- 208000007766 Kaposi sarcoma Diseases 0.000 claims 5
- 206010006187 Breast cancer Diseases 0.000 claims 4
- 208000026310 Breast neoplasm Diseases 0.000 claims 4
- 206010033128 Ovarian cancer Diseases 0.000 claims 4
- 208000002154 non-small cell lung carcinoma Diseases 0.000 claims 4
- 208000000461 Esophageal Neoplasms Diseases 0.000 claims 3
- 206010030155 Oesophageal carcinoma Diseases 0.000 claims 3
- 206010061535 Ovarian neoplasm Diseases 0.000 claims 3
- 201000004101 esophageal cancer Diseases 0.000 claims 3
- 208000029729 tumor suppressor gene on chromosome 11 Diseases 0.000 claims 3
- 206010005003 Bladder cancer Diseases 0.000 claims 2
- 206010008342 Cervix carcinoma Diseases 0.000 claims 2
- 206010023825 Laryngeal cancer Diseases 0.000 claims 2
- 206010058467 Lung neoplasm malignant Diseases 0.000 claims 2
- 206010025323 Lymphomas Diseases 0.000 claims 2
- 208000034176 Neoplasms, Germ Cell and Embryonal Diseases 0.000 claims 2
- 206010057444 Oropharyngeal neoplasm Diseases 0.000 claims 2
- 206010060862 Prostate cancer Diseases 0.000 claims 2
- 208000000236 Prostatic Neoplasms Diseases 0.000 claims 2
- 208000005718 Stomach Neoplasms Diseases 0.000 claims 2
- 208000024770 Thyroid neoplasm Diseases 0.000 claims 2
- 208000007097 Urinary Bladder Neoplasms Diseases 0.000 claims 2
- 208000006105 Uterine Cervical Neoplasms Diseases 0.000 claims 2
- 208000002495 Uterine Neoplasms Diseases 0.000 claims 2
- 210000004027 cell Anatomy 0.000 claims 2
- 201000010881 cervical cancer Diseases 0.000 claims 2
- 210000003236 esophagogastric junction Anatomy 0.000 claims 2
- 206010017758 gastric cancer Diseases 0.000 claims 2
- 201000010536 head and neck cancer Diseases 0.000 claims 2
- 208000014829 head and neck neoplasm Diseases 0.000 claims 2
- 201000006866 hypopharynx cancer Diseases 0.000 claims 2
- 206010023841 laryngeal neoplasm Diseases 0.000 claims 2
- 201000004962 larynx cancer Diseases 0.000 claims 2
- 201000005202 lung cancer Diseases 0.000 claims 2
- 208000020816 lung neoplasm Diseases 0.000 claims 2
- 238000004519 manufacturing process Methods 0.000 claims 2
- 201000001441 melanoma Diseases 0.000 claims 2
- 201000006958 oropharynx cancer Diseases 0.000 claims 2
- 201000002628 peritoneum cancer Diseases 0.000 claims 2
- 201000011549 stomach cancer Diseases 0.000 claims 2
- 201000002510 thyroid cancer Diseases 0.000 claims 2
- 206010044412 transitional cell carcinoma Diseases 0.000 claims 2
- 201000005112 urinary bladder cancer Diseases 0.000 claims 2
- 206010046766 uterine cancer Diseases 0.000 claims 2
- 108010012934 Albumin-Bound Paclitaxel Proteins 0.000 claims 1
- 206010055113 Breast cancer metastatic Diseases 0.000 claims 1
- 206010009944 Colon cancer Diseases 0.000 claims 1
- 206010014733 Endometrial cancer Diseases 0.000 claims 1
- 206010014759 Endometrial neoplasm Diseases 0.000 claims 1
- 201000001342 Fallopian tube cancer Diseases 0.000 claims 1
- 208000013452 Fallopian tube neoplasm Diseases 0.000 claims 1
- 208000008839 Kidney Neoplasms Diseases 0.000 claims 1
- 206010029350 Neurotoxicity Diseases 0.000 claims 1
- 208000015914 Non-Hodgkin lymphomas Diseases 0.000 claims 1
- 206010061902 Pancreatic neoplasm Diseases 0.000 claims 1
- 208000015634 Rectal Neoplasms Diseases 0.000 claims 1
- 206010038389 Renal cancer Diseases 0.000 claims 1
- 206010044221 Toxic encephalopathy Diseases 0.000 claims 1
- 208000009956 adenocarcinoma Diseases 0.000 claims 1
- 239000008280 blood Substances 0.000 claims 1
- 210000004369 blood Anatomy 0.000 claims 1
- 230000036765 blood level Effects 0.000 claims 1
- 201000008275 breast carcinoma Diseases 0.000 claims 1
- 208000029742 colonic neoplasm Diseases 0.000 claims 1
- 230000002357 endometrial effect Effects 0.000 claims 1
- 210000004602 germ cell Anatomy 0.000 claims 1
- 201000003115 germ cell cancer Diseases 0.000 claims 1
- 231100000226 haematotoxicity Toxicity 0.000 claims 1
- 201000010982 kidney cancer Diseases 0.000 claims 1
- 208000032839 leukemia Diseases 0.000 claims 1
- 208000015486 malignant pancreatic neoplasm Diseases 0.000 claims 1
- 231100000228 neurotoxicity Toxicity 0.000 claims 1
- 230000007135 neurotoxicity Effects 0.000 claims 1
- 210000003101 oviduct Anatomy 0.000 claims 1
- 210000000496 pancreas Anatomy 0.000 claims 1
- 201000002528 pancreatic cancer Diseases 0.000 claims 1
- 208000008443 pancreatic carcinoma Diseases 0.000 claims 1
- 230000036470 plasma concentration Effects 0.000 claims 1
- 206010038038 rectal cancer Diseases 0.000 claims 1
- 201000001275 rectum cancer Diseases 0.000 claims 1
- 102100033350 ATP-dependent translocase ABCB1 Human genes 0.000 abstract 1
- 101001017818 Homo sapiens ATP-dependent translocase ABCB1 Proteins 0.000 abstract 1
- 230000009610 hypersensitivity Effects 0.000 abstract 1
- RCINICONZNJXQF-XAZOAEDWSA-N taxol® Chemical compound O([C@@H]1[C@@]2(CC(C(C)=C(C2(C)C)[C@H](C([C@]2(C)[C@@H](O)C[C@H]3OC[C@]3(C21)OC(C)=O)=O)OC(=O)C)OC(=O)[C@H](O)[C@@H](NC(=O)C=1C=CC=CC=1)C=1C=CC=CC=1)O)C(=O)C1=CC=CC=C1 RCINICONZNJXQF-XAZOAEDWSA-N 0.000 abstract 1
- 230000001988 toxicity Effects 0.000 abstract 1
- 231100000419 toxicity Toxicity 0.000 abstract 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
-
- 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
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/337—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having four-membered rings, e.g. taxol
-
- 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
- A61K31/435—Heterocyclic 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
- A61K31/47—Quinolines; Isoquinolines
- A61K31/472—Non-condensed isoquinolines, e.g. papaverine
- A61K31/4725—Non-condensed isoquinolines, e.g. papaverine containing further heterocyclic rings
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
- A61P35/02—Antineoplastic agents specific for leukemia
Abstract
The application pertains to pharmaceutical combinations of orally administered paclitaxel and a P-gp inhibitor. The pharmaceutical combinations are suitable for the treatment of cancer in a subject and for reducing or preventing toxicity, hypersensitivity -type infusion reactions, and other negative outcomes resulting from or associated with intravenously administered paclitaxel (e.g., Taxol® or paclitaxel formulated with Cremophor®) therapy in a subject suffering from cancer.
Claims (49)
1. Use of a compound in the cture of a medicament for treatment of cancer in a subject in need thereof, wherein the subject is to be administered paclitaxel orally at an amount of about 100 mg/m2 to about 250 mg/m2 once a day and for 1-7 times a week; wherein the compound is Compound A: , wherein the medicament is ated to be administered to the subject at an amount of Compound A of about 15 mg, about 20 mg, about 25 mg, or about 30 mg once a day and for 1-7 times a week; and wherein Compound A is to be orally stered simultaneously with or prior to the paclitaxel.
2. Use of a compound in the manufacture of a medicament for reducing hematologic toxicity and/or neurotoxicity in a subject ing from cancer and undergoing paclitaxel therapy, wherein the subject is to be administered paclitaxel orally at an amount of about 100 mg/m2 to about 250 mg/m2 once a day and for 1-7 times a week; n the compound is Compound A: , wherein the medicament is formulated to administer Compound A to the subject at an amount of about 15 mg, about 20 mg, about 25 mg, or about 30 mg once a day and for 1-7 times a week; and wherein the plasma exposure of the orally administered paclitaxel, as measured by AUC(0?8), is equal to or greater than the plasma exposure, as measured by AUC(0?8), of enously administered paclitaxel at an amount of about 135 mg/m2 to 175 mg/m2 over a period of about 3 to about 24 hours once every 3 weeks, and wherein Compound A is to be orally administered simultaneously with or prior to the paclitaxel.
3. The use of claim 2, wherein the plasma re of the orally administered paclitaxel, as measured by AUC(0?8), is equal to or greater than the plasma re, as measured by AUC(0?8), of intravenously administered paclitaxel over a period of about 3 hours.
4. The use of claim 2, wherein the plasma exposure of the orally stered paclitaxel, as measured by AUC(0?8), is equal to or greater than the plasma exposure, as measured by AUC(0?8), of intravenously administered paclitaxel over a period of about 24 hours.
5. Use of a compound in the manufacture of a medicament for reducing or ting hypersensitivity-type infusion reactions associated with intravenously administered paclitaxel therapy in a subject suffering from cancer, wherein the subject is to be administered axel orally at an amount of about 100 mg/m2 to about 250 mg/m2 once a day and for 1-7 times a week; wherein the compound is Compound A: , wherein the medicament is to be administered to the subject at an amount of Compound A of about 15 mg, about 20 mg, about 25 mg, or about 30 mg once a day and for 1-7 times a week; and wherein the orally administered paclitaxel reac hes therapeutic blood or plasma levels in the subject, and n Compound A is to be orally administered simultaneously with or prior to the paclitaxel.
6. The use of any one of the preceding , wherein the paclitaxel is to be stered at an amount of about 150 mg/m2 to about 250 mg/m2.
7. The use of any one of claims 1 to 6, wherein the paclitaxel is to be administered at an amount of about 125 mg/m2 to about 250 mg/m2.
8. The use of any one of claims 1 to 6, wherein the paclitaxel is to be stered at an amount of about 125 mg/m2 to about 200 mg/m2.
9. The use of any one of claims 1 to 6, wherein the paclitaxel is to be stered at an amount of about 100 mg/m2 to about 250 mg/m2.
10. The use of any one of claims 1 to 6, wherein the paclitaxel is to be administered at an amount of about 100 mg/m2 to about 200 mg/m2.
11. The use of any one of the preceding claims, wherein the paclitaxel is to be administered at an amount of about 150 mg/m2.
12. The use of any one of the preceding claims, wherein the paclitaxel is to be administered at an amount of about 200 mg/m2.
13. The use of any one of claims 1 to 6, wherein the paclitaxel is to be administered at an amount of about 250 mg/m2.
14. The use of any one of the preceding claims, wherein the paclitaxel is to be administered 2-6 times per week.
15. The use of any one of the preceding claims, wherein the paclitaxel is to be administered 2-5 times per week.
16. The use of any one of the preceding claims, wherein the paclitaxel is to be stered at least twice per week.
17. The use of any one of the preceding , wherein the paclitaxel is to be administered at least 3 times per week.
18. The use of any one of the preceding claims, wherein the paclitaxel is to be administered at least 4 times per week.
19. The use of any one of the preceding claims, n the paclitaxel is to be administered 5 times per week.
20. The use of any one of the preceding claims, wherein the plasma exposure of the orally administered axel, as measured by AUC(0?8), is equal to or greater than the plasma re of intravenously administered paclitaxel at an amount of about 80 mg/m2 over a period of about 60 minutes, as measured by AUC(0?8).
21. The use of any one of the preceding claims, wherein the AUC(0?8) of the orally administered paclitaxel is greater than the 8) of intravenously administered paclitaxel at an amount of about 80 mg/m2 over a period of about 60 minutes.
22. The use of any one of the preceding claims, wherein the AUC(0?8) of the orally administered axel is at least about 10% greater than the AUC(0?8) of intravenously administered paclitaxel at an amount of about 80 mg/m2 over a period of about 60 minutes.
23. The use of any one of the preceding claims, wherein the AUC(0?8) of the orally administered paclitaxel is at least about 20% greater than the AUC(0?8) of intravenously administered paclitaxel at an amount of about 80 mg/m2 over a period of about 60 minutes.
24. The use of any one of the preceding claims, wherein the AUC(0?8) of the orally administered paclitaxel is at least about 30% greater than the AUC(0?8) of intravenously administered paclitaxel at an amount of about 80 mg/m2 over a period of about 60 minutes.
25. The use of any one of the preceding claims, wherein the AUC(0?8) of the orally administered paclitaxel is at least about 40% r than the AUC(0?8) of paclitaxel intravenously administered paclitaxel at an amount of about 80 mg/m2 over a period of about 60 minutes.
26. The use of any one of the preceding claims, wherein the AUC(0?8) of the orally administered paclitaxel is at least about 50% r than the AUC(0?8) of paclitaxel enously stered paclitaxel at an amount of about 80 mg/m2 over a period of about 60 minutes.
27. The use of any one of the preceding claims, wherein the AUC(0?8) of the orally administered paclitaxel is at least about 80% greater than the AUC(0?8) of axel intravenously administered paclitaxel at an amount of about 80 mg/m2 over a period of about 60 minutes.
28. The use of any one of the preceding , wherein the AUC(0?8) of the orally administered paclitaxel is at least about 100% greater than the AUC(0?8) of paclitaxel intravenously administered axel at an amount of about 80 mg/m2 over a period of about 60 minutes.
29. The use of any one of the preceding claims, wherein the AUC(0?8) of the orally administered paclitaxel is about 2,000 ng•h/mL to about 10,000 L.
30. The use of any one of the preceding claims, wherein the AUC(0?8) of the orally administered paclitaxel is about 3,000 ng•h/mL to about 7,000 ng•h/mL.
31. The use of any one of the preceding claims, wherein the AUC(0?8) of the orally administered paclitaxel is about 5,000 ng•h/mL to about 7,000 ng•h/mL.
32. The use of any one of the preceding claims, wherein the total amount of the axel to be orally administered per week is about 300 mg/m2 to about 1,500 mg/m2.
33. The use of any one of the preceding claims, wherein the medicament is formulated for Compound A and the paclitaxel to be administered on the same day.
34. The use of any one of the preceding claims, wherein the AUC(0?8) of the orally administered paclitaxel is equal to or r than the AUC(0?8) of intravenously administered paclitaxel at an amount of about 80 mg/m2 over a period of about 60 minutes in treating cancer.
35. The use of any one of the preceding claims, wherein the subject is suffering from metastatic breast cancer, and wherein the plasma exposure of the orally stered axel, as measured by 8), is equal to or greater than the plasma exposure, as measured by AUC(0?8), of enously administered paclitaxel at an amount of about 260 mg/m2 over a period of about 30 minutes once every 3 weeks.
36. The use of any one of the ing claims, wherein the subject is suffering from ll cell lung cancer, and n the plasma exposure of the orally administered paclitaxel, as measured by AUC(0?8), is equal to or greater than the plasma exposure, as measured by AUC(0?8), of intravenously administered paclitaxel at an amount of about 100 mg/m2 over a period of about 30 minutes once per week for 3 weeks.
37. The use of any one of the preceding claims, wherein the subject is suffering from adenocarcinoma of the pancreas, and wherein the plasma exposure of the orally administered paclitaxel, as measured by AUC(0?8), is equal to or greater than the plasma exposure, as measured by AUC(0?8), of intravenously administered paclitaxel at an amount of about 125 mg/m2 over a period of about 30 minutes to about 40 minutes once per week for 3 weeks.
38. The use of any one of the ing claims, wherein the subject is suffering from carcinoma of the ovary, and wherein the plasma exposure of the orally administered axel, as ed by AUC(0?8), is equal to or greater than the plasma exposure, as measured by AUC(0?8), of intravenously administered paclitaxel at an amount of about 135 mg/m2 to about 175 mg/m2 over a period of about 3 hours once every 3 weeks.
39. The use of any one of the preceding claims, wherein the subject is suffering from carcinoma of the breast, and wherein the plasma re of the orally administered paclitaxel, as measured by AUC(0?8), is equal to or greater than the plasma exposure, as ed by AUC(0?8), of intravenously administered paclitaxel at an amount of about 175 mg/m2 once every 3 weeks.
40. The use of any one of the preceding claims, wherein the subject is suffering from nonsmall cell lung carcinoma, and wherein the plasma exposure of the orally administered paclitaxel, as measured by AUC(0?8), is equal to or greater than the plasma exposure, as measured by 8), of intravenously administered axel at an amount of about 135 mg/m2 over a period of about 24 hours once every 3 weeks.
41. The use of any one of the preceding claims, wherein the subject is suffering from AIDS- related Kaposi's Sarcoma, and wherein the plasma exposure of the orally administered paclitaxel, as measured by AUC(0?8), is equal to or r than the plasma exposure, as measured by AUC(0?8), of enously administered paclitaxel at an amount of about 135 mg/m2 over a period of about 3 hours once every 3 weeks, or at an amount of about 100 mg/m2 over a period of about 3 hours once every 2 weeks.
42. The use of any one of the preceding claims, wherein the cancer is ed from the group consisting of breast cancer, pancreatic cancer, non-small cell lung cancer, ovarian cancer, AIDS- related Kaposi sarcoma, esophageal cancer, ma, lymphoma, uterine cancer, peritoneal cancer, fallopian tube cancer, endometrial cancer, cervical cancer, thyroid cancer, gastric cancer, gastroesophageal junction cancer, urothelial cancer, bladder cancer, oropharynx cancer, hypopharynx cancer, larynx cancer, head and neck cancer, germ cell /tumors, prostate cancer, colon cancer, rectal cancer, kidney cancer, leukemia, and non-Hodgkin lymphoma.
43. The use of any one of the preceding claims, wherein the cancer is selected from the group consisting of breast cancer, pancreatic , non-small cell lung cancer, n cancer, AIDS- related Kaposi sarcoma, esophageal cancer, melanoma, lymphoma, uterine cancer, peritoneal cancer, fallopian tube , endometrial , cervical cancer, thyroid cancer, gastric cancer, gastroesophageal junction cancer, urothelial cancer, bladder , oropharynx cancer, hypopharynx cancer, larynx cancer, head and neck cancer, and germ cell cancer/tumors.
44. The use of any one of the ing claims, wherein the cancer is selected from the group consisting of breast cancer, all cell lung cancer, ovarian cancer, AIDS-related Kaposi sarcoma, esophageal cancer, bladder cancer, prostate cancer, and melanoma.
45. The use of any one of the preceding claims, wherein the cancer is selected from the group consisting of breast cancer, non-small cell lung cancer, ovarian cancer, and AIDS-related Kaposi sarcoma.
46. The use of any one of the preceding claims, wherein the ment is formulated for Compound A to be orally administered at an amount of about 15 mg.
47. The use of any one of the preceding , wherein Compound A is to be administered before the paclitaxel is to be administered.
48. The use of any one of the preceding claims, wherein the intravenously administered paclitaxel is paclitaxel in polyethoxylated castor oil.
49. The use of any one of claims 1 to 47, wherein the intravenously administered paclitaxel is protein-bound paclitaxel.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201562195243P | 2015-07-21 | 2015-07-21 | |
| PCT/IB2016/001132 WO2017013490A2 (en) | 2015-07-21 | 2016-07-21 | Therapeutic combinations of orally administered paclitaxel and a p-gp inhibitor for the treatment of cancer |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| NZ739270A NZ739270A (en) | 2024-10-25 |
| NZ739270B2 true NZ739270B2 (en) | 2025-01-28 |
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