US20070104721A1 - Antineoplastic combinations with mTOR inhibitor,herceptin, and/or hki-272 - Google Patents
Antineoplastic combinations with mTOR inhibitor,herceptin, and/or hki-272 Download PDFInfo
- Publication number
- US20070104721A1 US20070104721A1 US11/592,066 US59206606A US2007104721A1 US 20070104721 A1 US20070104721 A1 US 20070104721A1 US 59206606 A US59206606 A US 59206606A US 2007104721 A1 US2007104721 A1 US 2007104721A1
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- United States
- Prior art keywords
- herceptin
- hki
- rapamycin
- mammal
- unit
- Prior art date
- Legal status (The legal status 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 status listed.)
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- JWNPDZNEKVCWMY-VQHVLOKHSA-N CCOC1=C(NC(=O)/C=C/CN(C)C)C=C2C(=C1)N=CC(C#N)=C2NC1=CC=C(OCC2=CC=CC=N2)C(Cl)=C1 Chemical compound CCOC1=C(NC(=O)/C=C/CN(C)C)C=C2C(=C1)N=CC(C#N)=C2NC1=CC=C(OCC2=CC=CC=N2)C(Cl)=C1 JWNPDZNEKVCWMY-VQHVLOKHSA-N 0.000 description 1
- QFJCIRLUMZQUOT-HPLJOQBZSA-N CO[C@H]1C[C@@H]2CC[C@@H](C)[C@@](O)(O2)C(=O)C(=O)N2CCCC[C@H]2C(=O)O[C@H]([C@H](C)C[C@@H]2CC[C@@H](O)[C@H](OC)C2)CC(=O)[C@H](C)/C=C(\C)[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)/C=C/C=C/C=C/1C Chemical compound CO[C@H]1C[C@@H]2CC[C@@H](C)[C@@](O)(O2)C(=O)C(=O)N2CCCC[C@H]2C(=O)O[C@H]([C@H](C)C[C@@H]2CC[C@@H](O)[C@H](OC)C2)CC(=O)[C@H](C)/C=C(\C)[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)/C=C/C=C/C=C/1C QFJCIRLUMZQUOT-HPLJOQBZSA-N 0.000 description 1
- 0 [1*]C.[2*]C[3*]C1=CC=C(NC2=C(C#N)C=NC3=CC(OC[5*])=C(NC(=O)/C=C/CN([4*])C)C=C32)C=C1 Chemical compound [1*]C.[2*]C[3*]C1=CC=C(NC2=C(C#N)C=NC3=CC(OC[5*])=C(NC(=O)/C=C/CN([4*])C)C=C32)C=C1 0.000 description 1
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
-
- 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
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- 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
- A61K31/4353—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 ortho- or peri-condensed with heterocyclic ring systems
- A61K31/436—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 ortho- or peri-condensed with heterocyclic ring systems the heterocyclic ring system containing a six-membered ring having oxygen as a ring hetero atom, e.g. rapamycin
-
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- 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
- A61K31/4709—Non-condensed quinolines and containing further heterocyclic rings
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- 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
- A61K31/4738—Quinolines; Isoquinolines ortho- or peri-condensed with heterocyclic ring systems
- A61K31/4745—Quinolines; Isoquinolines ortho- or peri-condensed with heterocyclic ring systems condensed with ring systems having nitrogen as a ring hetero atom, e.g. phenantrolines
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- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
- A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
- A61K39/39558—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against tumor tissues, cells, antigens
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
- A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
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- A—HUMAN NECESSITIES
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- A61P35/02—Antineoplastic agents specific for leukemia
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- A—HUMAN NECESSITIES
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
- A61P35/04—Antineoplastic agents specific for metastasis
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- A—HUMAN NECESSITIES
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P5/00—Drugs for disorders of the endocrine system
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
Definitions
- FIG. 3 is a 3-dimensional contour plot with the plane at 0% representing additive interaction, and peaks and valleys representing areas of synergy or antagonism between the herceptin and HKI-272 in MDA-MB-361 [HER-2 + (non-amplified); adenocarcinoma; ATCC HTB 27] cells.
- an HKI-272 refers to a compound having the following core, or a derivative or pharmaceutically acceptable salt thereof. Suitable derivatives may include, e.g., an ester, ether, or carbamate.
- the core structure, HKI-272 has the chemical name (E)-N- ⁇ 4-[3-chloro-4-(2-pyridinylmethoxy) anilino]-3-cyano-7-ethoxy-6-quinolinyl ⁇ -4-(dimethylam ino)-2-butenamide.
- a pharmaceutical pack contains a course of treatment of a neoplasm for one individual mammal, wherein the pack contains units of an mTOR inhibitor in unit dosage form and units of herceptin in unit dosage form, optionally further in combination with units of an HKI-272 in unit dosage form.
- a pharmaceutical pack contains a course of treatment of a neoplasm for one individual mammal, wherein the pack contains units of an mTOR inhibitor in unit dosage form and units of HKI-272 in unit dosage form, optionally further in combination with units of herceptin in unit dosage form.
- herceptin single doses and multiple doses are contemplated.
- a single loading dose of herceptin is administered as a 90-minute intravenous infusion in a range of about 4-5 mg/kg on day 1, followed by about 2 mg/kg per week starting on day 8.
- 3 weeks is 1 cycle. From 1, to 2 to 3, weeks may be provided between cycles.
- Herceptin may also be given at a dose of 6 mg/kg once every 3-4 weeks.
- herceptin may also be given after completion of chemotherapy as maintenance therapy.
- a compound of the invention is in the form of a unit dose.
- Suitable unit dose forms include tablets, capsules and powders in sachets or vials.
- Such unit dose forms may contain from 0.1 to 300 mg of a compound of the invention and preferably from 2 to 100 mg.
- Still further preferred unit dosage forms contain 5 to 50 mg of a compound of the present invention.
- the compounds of the present invention can be administered at a dose range of about 0.01 to 100 mg/kg or preferably at a dose range of 0.1 to 10 mg/kg.
- the compounds are administered orally from 1 to 6 times a day, more usually from I to 4 times a day.
- the compounds may be administered through another suitable route, e.g., intravenous.
- Fludarabine (9-H-Purin-6-amine,2-fluoro-9-(5-O-phosphono-(beta)-D-a-rabinofuranosyl) is commercially available as a liquid injectable containing 50 mg/vial (FLUDARA).
- 6-Mercaptopurine (1,7-dihydro-6H-purine-6-thione) is commercially available in 50 mg oral tablets (PURINETHOL).
- the invention includes a product or pharmaceutical pack containing a course of an anti-neoplastic treatment for one individual mammal comprising one or more container(s) having one, one to four, or more unit(s) of an mTOR inhibitor (e.g., temsirolimus) in unit dosage form and, optionally, one, one to four, or more unit(s) of herceptin, and optionally, another active agent.
- an mTOR inhibitor e.g., temsirolimus
- Temsirolimus is administered IV weekly over a 30-minute period using an in-line filter and an automatic dispensing pump.
- antihistamine diphenhydramine, 25 to 50 mg IV or the equivalent
- temsirolimus infusion is administered.
- the Pritchard and Shipman method was modified to allow determination of the combination effects at different levels of statistical significance (p-values 0.05, 0.01, 0.001). A p-value of 0.05 is considered significant.
- the method of estimating statistical variability within each experiment was also modified. Variability was determined across all compound combinations, whereas in the original version, variability was estimated separately for each compound combination. It is believed that better estimates of the variability are obtained with the modified approach. In general, single points of synergy or antagonism are not considered representative of either synergistic or antagonistic activity. Thus, single point peaks or valleys are disregarded in the analysis.
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Epidemiology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Mycology (AREA)
- Oncology (AREA)
- Microbiology (AREA)
- Immunology (AREA)
- Biomedical Technology (AREA)
- Hematology (AREA)
- Diabetes (AREA)
- Endocrinology (AREA)
- Urology & Nephrology (AREA)
- Physical Education & Sports Medicine (AREA)
- Pulmonology (AREA)
- Neurology (AREA)
- Neurosurgery (AREA)
- Reproductive Health (AREA)
- Obesity (AREA)
- Dermatology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicinal Preparation (AREA)
Priority Applications (6)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US11/592,066 US20070104721A1 (en) | 2005-11-04 | 2006-11-02 | Antineoplastic combinations with mTOR inhibitor,herceptin, and/or hki-272 |
US12/539,914 US20090297519A1 (en) | 2005-11-04 | 2009-08-12 | ANTINEOPLASTIC COMBINATIONS WITH mTOR INHIBITOR, TRASTUZUMAB, AND/OR HKI-272 |
US13/454,768 US20120308560A1 (en) | 2005-11-04 | 2012-04-24 | Antineoplastic Combinations with mTOR Inhibitor, Trastuzumab and/or HKI-272 |
US13/874,147 US10729672B2 (en) | 2005-11-04 | 2013-04-30 | Antineoplastic combinations with mTOR inhibitor, trastuzumab and/or HKI-272 |
US17/548,340 US20220354820A1 (en) | 2005-11-04 | 2021-12-10 | Antineoplastic Combinations with m-TOR Inhibitor, Trastuzumab and/or HKI-272 |
US17/871,397 US20230201155A1 (en) | 2005-11-04 | 2022-07-22 | Antineoplastic Combinations with m-TOR Inhibitor, Trastuzumab and/or HKI-272 |
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US73356205P | 2005-11-04 | 2005-11-04 | |
US83750906P | 2006-08-14 | 2006-08-14 | |
US11/592,066 US20070104721A1 (en) | 2005-11-04 | 2006-11-02 | Antineoplastic combinations with mTOR inhibitor,herceptin, and/or hki-272 |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US12/539,914 Division US20090297519A1 (en) | 2005-11-04 | 2009-08-12 | ANTINEOPLASTIC COMBINATIONS WITH mTOR INHIBITOR, TRASTUZUMAB, AND/OR HKI-272 |
Publications (1)
Publication Number | Publication Date |
---|---|
US20070104721A1 true US20070104721A1 (en) | 2007-05-10 |
Family
ID=37845244
Family Applications (6)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US11/592,066 Abandoned US20070104721A1 (en) | 2005-11-04 | 2006-11-02 | Antineoplastic combinations with mTOR inhibitor,herceptin, and/or hki-272 |
US12/539,914 Abandoned US20090297519A1 (en) | 2005-11-04 | 2009-08-12 | ANTINEOPLASTIC COMBINATIONS WITH mTOR INHIBITOR, TRASTUZUMAB, AND/OR HKI-272 |
US13/454,768 Abandoned US20120308560A1 (en) | 2005-11-04 | 2012-04-24 | Antineoplastic Combinations with mTOR Inhibitor, Trastuzumab and/or HKI-272 |
US13/874,147 Active 2027-02-14 US10729672B2 (en) | 2005-11-04 | 2013-04-30 | Antineoplastic combinations with mTOR inhibitor, trastuzumab and/or HKI-272 |
US17/548,340 Pending US20220354820A1 (en) | 2005-11-04 | 2021-12-10 | Antineoplastic Combinations with m-TOR Inhibitor, Trastuzumab and/or HKI-272 |
US17/871,397 Pending US20230201155A1 (en) | 2005-11-04 | 2022-07-22 | Antineoplastic Combinations with m-TOR Inhibitor, Trastuzumab and/or HKI-272 |
Family Applications After (5)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US12/539,914 Abandoned US20090297519A1 (en) | 2005-11-04 | 2009-08-12 | ANTINEOPLASTIC COMBINATIONS WITH mTOR INHIBITOR, TRASTUZUMAB, AND/OR HKI-272 |
US13/454,768 Abandoned US20120308560A1 (en) | 2005-11-04 | 2012-04-24 | Antineoplastic Combinations with mTOR Inhibitor, Trastuzumab and/or HKI-272 |
US13/874,147 Active 2027-02-14 US10729672B2 (en) | 2005-11-04 | 2013-04-30 | Antineoplastic combinations with mTOR inhibitor, trastuzumab and/or HKI-272 |
US17/548,340 Pending US20220354820A1 (en) | 2005-11-04 | 2021-12-10 | Antineoplastic Combinations with m-TOR Inhibitor, Trastuzumab and/or HKI-272 |
US17/871,397 Pending US20230201155A1 (en) | 2005-11-04 | 2022-07-22 | Antineoplastic Combinations with m-TOR Inhibitor, Trastuzumab and/or HKI-272 |
Country Status (17)
Country | Link |
---|---|
US (6) | US20070104721A1 (fr) |
EP (2) | EP3488866A1 (fr) |
JP (7) | JP2009514870A (fr) |
KR (1) | KR101354828B1 (fr) |
CN (1) | CN103110948A (fr) |
AR (1) | AR057854A1 (fr) |
AU (1) | AU2006311877A1 (fr) |
BR (1) | BRPI0618042A2 (fr) |
CA (1) | CA2626326C (fr) |
CR (1) | CR9901A (fr) |
EC (1) | ECSP088423A (fr) |
IL (1) | IL190805A (fr) |
NO (1) | NO20081837L (fr) |
PE (1) | PE20070763A1 (fr) |
RU (2) | RU2451524C2 (fr) |
TW (1) | TW200803892A (fr) |
WO (1) | WO2007056118A1 (fr) |
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WO2009054001A1 (fr) * | 2007-10-22 | 2009-04-30 | Biocon Limited | Composition pharmaceutique et procédé correspondant |
US20090312360A1 (en) * | 2008-06-17 | 2009-12-17 | Wyeth | Antineoplastic Combinations Containing HKI-272 and Vinorelbine |
US20100081681A1 (en) * | 2006-08-16 | 2010-04-01 | Blagosklonny Mikhail V | Methods and compositions for preventing or treating age-related diseases |
US20100087482A1 (en) * | 2005-02-03 | 2010-04-08 | Haber Daniel A | Method for Treating Gefitinib Resistant Cancer |
US20100113474A1 (en) * | 2008-08-04 | 2010-05-06 | Wyeth | Antineoplastic Combinations of 4-Anilino-3-Cyanoquinolines and Capecitabine |
US20100260733A1 (en) * | 2009-04-10 | 2010-10-14 | Haiyan Qi | Novel anti aging agents and methods to identify them |
WO2010117633A1 (fr) | 2009-04-06 | 2010-10-14 | Wyeth Llc | Régime de traitement à l'aide de nératinib pour un cancer du sein |
US20110111059A1 (en) * | 2008-05-21 | 2011-05-12 | Jianhui Guo | Compositions Comprising Quinazoline Derivatives, Preparation Methods and Uses Thereof |
WO2011070499A1 (fr) | 2009-12-11 | 2011-06-16 | Wyeth Llc | Biomarqueurs de la voie de la phosphatidylinotisol-3-kinase |
US20110165257A1 (en) * | 2009-11-09 | 2011-07-07 | Wyeth Llc | Coated drug spheroids and uses thereof for eliminating or reducing conditions such as emesis and diarrhea |
WO2011087926A1 (fr) | 2010-01-13 | 2011-07-21 | Wyeth Llc | Point de découpage dans l'expression de la protéine pten qui identifie avec précision les tumeurs et qui permet de prédire la réponse médicamenteuse à un inhibiteur de pan-erbb |
US9139558B2 (en) | 2007-10-17 | 2015-09-22 | Wyeth Llc | Maleate salts of (E)-N-{4-[3-Chloro-4-(2-pyridinylmethoxy)anilino]-3-cyano-7-ethoxy-6-quinolinyl}-4-(dimethylamino)-2-butenamide and crystalline forms thereof |
WO2018133838A1 (fr) * | 2017-01-22 | 2018-07-26 | 江苏恒瑞医药股份有限公司 | Utilisations d'un inhibiteur de egfr/her2 combiné à un médicament anti-métabolique de type pyrimidine |
US10729672B2 (en) | 2005-11-04 | 2020-08-04 | Wyeth Llc | Antineoplastic combinations with mTOR inhibitor, trastuzumab and/or HKI-272 |
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