US20070104721A1 - Antineoplastic combinations with mTOR inhibitor,herceptin, and/or hki-272 - Google Patents

Antineoplastic combinations with mTOR inhibitor,herceptin, and/or hki-272 Download PDF

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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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Prior art keywords
herceptin
hki
rapamycin
mammal
unit
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Abandoned
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US11/592,066
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English (en)
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Laurence Moore
Charles Zacharchuk
Sridhar Rabindran
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Wyeth LLC
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Wyeth LLC
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=37845244&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=US20070104721(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Wyeth LLC filed Critical Wyeth LLC
Priority to US11/592,066 priority Critical patent/US20070104721A1/en
Assigned to WYETH reassignment WYETH ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: RABINDRAN, SRIDHAR K., MOORE, LAURENCE, ZACHARCHUK, CHARLES
Publication of US20070104721A1 publication Critical patent/US20070104721A1/en
Priority to US12/539,914 priority patent/US20090297519A1/en
Priority to US13/454,768 priority patent/US20120308560A1/en
Priority to US13/874,147 priority patent/US10729672B2/en
Priority to US17/548,340 priority patent/US20220354820A1/en
Priority to US17/871,397 priority patent/US20230201155A1/en
Abandoned legal-status Critical Current

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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
    • 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
    • A61K31/4353—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
    • 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
    • A61K31/4709—Non-condensed quinolines and containing further heterocyclic rings
    • 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
    • A61K31/4738—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
    • 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
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A—HUMAN NECESSITIES
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/08—Drugs for disorders of the urinary system of the prostate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A—HUMAN NECESSITIES
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    • A—HUMAN NECESSITIES
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    • A61P19/00—Drugs for skeletal disorders
    • A—HUMAN NECESSITIES
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A61P35/02—Antineoplastic agents specific for leukemia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A61P35/04—Antineoplastic agents specific for metastasis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • 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
    • 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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  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
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US11/592,066 2005-11-04 2006-11-02 Antineoplastic combinations with mTOR inhibitor,herceptin, and/or hki-272 Abandoned US20070104721A1 (en)

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)

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US12/539,914 Division US20090297519A1 (en) 2005-11-04 2009-08-12 ANTINEOPLASTIC COMBINATIONS WITH mTOR INHIBITOR, TRASTUZUMAB, AND/OR HKI-272

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US20070104721A1 true US20070104721A1 (en) 2007-05-10

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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)

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US (6) US20070104721A1 (no)
EP (2) EP3488866A1 (no)
JP (7) JP2009514870A (no)
KR (1) KR101354828B1 (no)
CN (1) CN103110948A (no)
AR (1) AR057854A1 (no)
AU (1) AU2006311877A1 (no)
BR (1) BRPI0618042A2 (no)
CA (1) CA2626326C (no)
CR (1) CR9901A (no)
EC (1) ECSP088423A (no)
IL (1) IL190805A (no)
NO (1) NO20081837L (no)
PE (1) PE20070763A1 (no)
RU (2) RU2451524C2 (no)
TW (1) TW200803892A (no)
WO (1) WO2007056118A1 (no)

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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 (en) 2009-04-06 2010-10-14 Wyeth Llc Treatment regimen utilizing neratinib for breast cancer
US20110111059A1 (en) * 2008-05-21 2011-05-12 Jianhui Guo Compositions Comprising Quinazoline Derivatives, Preparation Methods and Uses Thereof
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WO2011087926A1 (en) 2010-01-13 2011-07-21 Wyeth Llc A CUT-POINT IN PTEN PROTEIN EXPRESSION THAT ACCURATELY IDENTIFIES TUMORS AND IS PREDICTIVE OF DRUG RESPONSE TO A PAN-ErbB INHIBITOR
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 (zh) * 2017-01-22 2018-07-26 江苏恒瑞医药股份有限公司 Egfr/her2抑制剂联合嘧啶类抗代谢药物的用途
US10729672B2 (en) 2005-11-04 2020-08-04 Wyeth Llc Antineoplastic combinations with mTOR inhibitor, trastuzumab and/or HKI-272

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