US20140329786A1 - Combination treatment of cancer - Google Patents

Combination treatment of cancer Download PDF

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Publication number
US20140329786A1
US20140329786A1 US14/361,718 US201214361718A US2014329786A1 US 20140329786 A1 US20140329786 A1 US 20140329786A1 US 201214361718 A US201214361718 A US 201214361718A US 2014329786 A1 US2014329786 A1 US 2014329786A1
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Prior art keywords
combination
pharmaceutically acceptable
cancer
treatment
azd5363
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US14/361,718
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English (en)
Inventor
Barry Robert Davies
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AstraZeneca AB
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AstraZeneca AB
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Application filed by AstraZeneca AB filed Critical AstraZeneca AB
Priority to US14/361,718 priority Critical patent/US20140329786A1/en
Assigned to ASTRAZENECA UK LIMITED reassignment ASTRAZENECA UK LIMITED ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: DAVIES, BARRY ROBERT
Assigned to ASTRAZENECA AB reassignment ASTRAZENECA AB ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: ASTRAZENECA UK LIMITED
Publication of US20140329786A1 publication Critical patent/US20140329786A1/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
    • 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
    • A61K31/495—Heterocyclic 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
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with 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
    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/138—Aryloxyalkylamines, e.g. propranolol, tamoxifen, phenoxybenzamine
    • 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
    • A61K31/275—Nitriles; Isonitriles
    • A61K31/277—Nitriles; Isonitriles having a ring, e.g. verapamil
    • 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
    • A61K31/4164—1,3-Diazoles
    • A61K31/4166—1,3-Diazoles having oxo groups directly attached to the heterocyclic ring, e.g. phenytoin
    • 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
    • A61K31/495—Heterocyclic 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
    • A61K31/50—Pyridazines; Hydrogenated pyridazines
    • A61K31/5025—Pyridazines; Hydrogenated pyridazines ortho- or peri-condensed with heterocyclic ring systems
    • 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
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/58—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
    • 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
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/08—Drugs for disorders of the urinary system of the prostate

Definitions

  • Cancer is also a major cause of morbidity in the UK with nearly 260,000 new cases (excluding non-melanoma skin cancer) registered in 1997. Cancer is a disease that affects mainly older people, with 65% of cases occurring in those over 65. Since the average life expectancy in the UK has almost doubled since the mid nineteenth century, the population at risk of cancer has grown. Death rates from other causes of death, such as heart disease, have fallen in recent years while deaths from cancer have remained relatively stable. The result is that 1 in 3 people will be diagnosed with cancer during their lifetime and 1 in 4 people will die from cancer. In people under the age of 75, deaths from cancer outnumber deaths from diseases of the circulatory system, including ischaemic heart disease and stroke. In 2000, there were 151,200 deaths from cancer. Over one fifth (22%) of these were from lung cancer, and a quarter (26%) from cancers of the large bowel, breast and prostate.
  • this period is within 8 days.
  • this period is within 4 days.
  • this period is within 3 days.
  • this period is within 24 hours.
  • the other combination partner refers to MDV-3100; AZD3514; abiraterone, or an ester prodrug thereof; or bicalutamide; in order to provide a range of further embodiments of the invention.
  • a combination comprising AZD5363 with MDV-3100.
  • the cancer is in a non-metastatic state.
  • a pharmaceutical composition which comprises AZD5363, or a pharmaceutically acceptable salt thereof; and abiraterone, or a pharmaceutically acceptable salt thereof; in association with a pharmaceutically acceptable diluent or carrier.
  • the combination of the present invention might be used to treat a patient who has no metastases to stop them occurring, or to lengthen the time period before they occur, and to a patient who already has metastases to treat the metastases themselves.
  • the treatment of cancer may refer to treatment of an established primary tumour or tumours and developing primary tumour or tumours.
  • a pharmaceutical composition which comprises AZD5363, or a pharmaceutically acceptable salt thereof, in association with a pharmaceutically acceptable diluent or carrier; in combination with a pharmaceutical composition which comprises ‘the other combination partner’ (as defined above), or a pharmaceutically acceptable salt thereof, in association with a pharmaceutically acceptable diluent or carrier, for use in the treatment of cancer.
  • kits comprising AZD5363, or a pharmaceutically acceptable salt thereof; and ‘the other combination partner’ (as defined above) or a pharmaceutically acceptable salt thereof; optionally with instructions for use; for use in the treatment of cancer.
  • the AZD5363 is dosed to a patient at 300-1100 mg per day on the days when it is dosed, and it is dosed for two consecutive days and then not dosed for five consecutive days thereafter within a seven day dosage cycle.
  • the ‘other combination partner’ (as defined above) will normally be administered (i.e. dosed) to a warm-blooded animal at a unit dose, of an amount known to the skilled practitioner as a therapeutically effective dose.
  • the active ingredients may be compounded with an appropriate and convenient amount of excipients which may vary from about 5 to about 98 percent by weight of the total composition.
  • Dosage unit forms will generally contain about 20 mg to about 500 mg of each active ingredient.
  • the daily dose will necessarily be varied depending upon the host treated, the particular route of administration, and the severity of the illness being treated. Accordingly the optimum dosage may be determined by the practitioner who is treating any particular patient.
  • the dosage of each of the drugs and their proportions have to be composed so that the best possible treatment effects, as defined by national and international guidelines (which are periodically reviewed and re-defined), will be met.
  • the abiraterone acetate is dosed orally to a patient at 750-1250 mg per day on the days when it is dosed, and it is dosed every day of the week. (i.e. continuous dosing).
  • the abiraterone acetate is dosed orally to a patient at 800-1200 mg per day on the days when it is dosed, and it is dosed every day of the week. (i.e. continuous dosing).
  • the abiraterone acetate is dosed orally to a patient at 900-1100 mg per day on the days when it is dosed.
  • the abiraterone acetate is dosed orally to a patient at 900-1100 mg per day on the days when it is dosed, and it is dosed every day of the week. (i.e. continuous dosing).
  • the MDV-3100 is dosed orally to a patient at 150-170 mg per day on the days when it is dosed.
  • FIG. 2 Inhibition of cell growth and enhanced cell death in VCAP cells from combination use of AZD5363 with MDV3100.
  • ‘Tz’ represents the number of live cells at time zero
  • ‘C’ represents the control growth
  • ‘Ti’ represents the number of live cells in the presence of each drug regimen. This formula gives a growth percentage from ⁇ 100% to +100%. Negative scores are for cell killing and positive scores are for anti-proliferation. The data are presented in FIG. 1 and FIG. 2 . Synergism of the drug combination was evaluated using a unified approach described by C. Harbron (Stat. Med. 2010 Jul. 20; 29(16): 1746-56).

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Urology & Nephrology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
US14/361,718 2011-11-30 2012-11-30 Combination treatment of cancer Abandoned US20140329786A1 (en)

Priority Applications (1)

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US14/361,718 US20140329786A1 (en) 2011-11-30 2012-11-30 Combination treatment of cancer

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201161564975P 2011-11-30 2011-11-30
US14/361,718 US20140329786A1 (en) 2011-11-30 2012-11-30 Combination treatment of cancer
PCT/GB2012/052969 WO2013079964A1 (en) 2011-11-30 2012-11-30 Combination treatment of cancer

Related Parent Applications (1)

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PCT/GB2012/052969 A-371-Of-International WO2013079964A1 (en) 2011-11-30 2012-11-30 Combination treatment of cancer

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US15/018,157 Continuation US9737540B2 (en) 2011-11-30 2016-02-08 Combination treatment of cancer

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US20140329786A1 true US20140329786A1 (en) 2014-11-06

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US14/361,718 Abandoned US20140329786A1 (en) 2011-11-30 2012-11-30 Combination treatment of cancer
US15/018,157 Active US9737540B2 (en) 2011-11-30 2016-02-08 Combination treatment of cancer

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EP (1) EP2785349B2 (enExample)
JP (1) JP6309454B2 (enExample)
KR (1) KR102035361B1 (enExample)
CN (1) CN103945849B (enExample)
AU (2) AU2012321110B2 (enExample)
CA (1) CA2856646C (enExample)
CY (1) CY1122624T1 (enExample)
DK (1) DK2785349T4 (enExample)
ES (1) ES2762250T5 (enExample)
FI (1) FI2785349T4 (enExample)
HR (1) HRP20191982T4 (enExample)
HU (1) HUE046667T2 (enExample)
IL (1) IL232530B (enExample)
LT (1) LT2785349T (enExample)
MX (1) MX367640B (enExample)
MY (1) MY175800A (enExample)
PH (1) PH12014500943A1 (enExample)
PL (1) PL2785349T5 (enExample)
PT (1) PT2785349T (enExample)
RS (1) RS59493B2 (enExample)
RU (1) RU2640485C2 (enExample)
SG (1) SG11201401471PA (enExample)
SI (1) SI2785349T2 (enExample)
SM (1) SMT201900708T1 (enExample)
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