# US 10,117,872 B2 · Tyrosine kinase inhibitors for use in a method of treating cancer in association with a reduced caloric intake

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- Number: US 10,117,872 B2
- Document ID: US10117872B2
- Status: Granted
- Kind: B2
- Application number: 15/129,569
- Filed: 2015-03-30
- Published: 2017-06-22
- Granted: 2018-11-06
- Earliest claimed: 2014-03-28
- Assignees: Universita' Degli Studi Di Genova; L-Nutra Inc.
- Applicants: UNIVERSITÀ{grave over ( )} DEGLI STUDI DI GENOVA; L-Nutra Inc.
- Inventors: Alberto Ballestrero; Irene Caffa; Valter Longo; Alessio Nencioni; Patrizio Odetti; Franco Patrone
- Web page: https://patentgrep.com/patent/US10117872B2

## CPC

- A61K 31/517: ortho- or peri-condensed with carbocyclic ring systems, e.g. quinazoline, perimidine
- A61K 31/403: condensed with carbocyclic rings, e.g. carbazole
- A61K 31/437: the heterocyclic ring system containing a five-membered ring having nitrogen as a ring hetero atom, e.g. indolizine, beta-carboline
- A61K 31/44: Non condensed pyridines; Hydrogenated derivatives thereof
- A61K 31/4439: containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole (nicotine A61K31/465)
- A61K 31/4545: containing a six-membered ring with nitrogen as a ring hetero atom, e.g. pipamperone, anabasine
- A61K 31/47: Quinolines; Isoquinolines
- A61K 31/496: Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
- A61K 31/506: not condensed and containing further heterocyclic rings
- A61K 31/519: ortho- or peri-condensed with heterocyclic rings
- A61K 31/5355: Non-condensed oxazines and containing further heterocyclic rings
- A61K 31/5365: ortho- or peri-condensed with heterocyclic ring systems
- A61P 35/00: Antineoplastic agents
- A61P 35/02: specific for leukemia
- A61P 35/04: specific for metastasis
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

A tyrosine kinase inhibitor (TKI) for use in a method for the treatment of cancer in a patient, wherein the method comprises subjecting the patient to reduced caloric intake, i.e a daily caloric intake reduced by 10-100%, including starvation, for a period of 24-190 hours and administering the tyrosine kinase inhibitorto the patient during such period; the tyrosine kinase inhibitor is preferably selected among Lapatinib, Crizotinib, Gefitinib, Erlotinib, Afatinib and Regorafenib.

## Claims

### Claim 1

A method for treating a human patient affected by non-small cell lung cancer or breast cancer, said method comprising subjecting the patient to reduced caloric intake for a period of 24-190 hours while the patient is being treated with a tyrosine kinase inhibitor (TKI),
wherein:
when the patient is affected by non-small cell lung cancer, the TKI is Crizotinib,
when the patient is affected by breast cancer, the TKI is Lapatinib, and
the reduced caloric intake corresponds to less than 300 kcal/day.

### Claim 2 (depends on 1)

The method according to claim 1, wherein said period of reduced caloric intake is 48 to 150 hours.

### Claim 3 (depends on 1)

The method according to claim 1, wherein said period of reduced caloric intake is about 120 hours.

### Claim 4 (depends on 1)

The method according to claim 1, wherein said period of reduced caloric intake with concurrent administration of the tyrosine kinase inhibitor to the patient is repeated one or more times after respective periods of 5-60 days, during which said patient is given the tyrosine kinase inhibitor while following a diet involving a regular caloric intake.

### Claim 5 (depends on 1)

The method according to claim 1, wherein said reduced caloric intake corresponds to 100-200 Kcal/day.

### Claim 6 (depends on 1)

The method according to claim 1, wherein said reduced caloric intake is obtained by fasting or by means of dietetic food with reduced caloric and/or protein content but containing all necessary micronutrients to prevent malnutrition.