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Compositions and methods of treating liver cancer

A technology of liver cancer and radiotherapy, applied in the field of compositions and methods for treating liver cancer, capable of solving problems such as inapplicability of surgical resection, deterioration of cases, and complicated treatment of liver cancer

Inactive Publication Date: 2016-05-25
英丘伦股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, surgical resection is sometimes not indicated due to tumor size or location and concurrent liver disease (such as advanced cirrhosis)
Furthermore, even when surgical resection is feasible, tumor recurrence / recurrence at five years after resection makes progression in 70% of cases
HCC treatment is complicated by the fact that chemotherapy tends to be less effective in HCC, possibly due to the enhanced ability of HCC cells to efflux chemotherapeutic agents

Method used

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  • Compositions and methods of treating liver cancer
  • Compositions and methods of treating liver cancer
  • Compositions and methods of treating liver cancer

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0093] Example 1: Study Plan (Description of General Study Design and Plan)

[0094] After signing the informed consent, the patients underwent a screening clinical examination. Compliance with inclusion / exclusion was confirmed prior to study therapy.

[0095] Study subjects were consecutively enrolled into 7 dosing cohorts. The dose was increased with each subsequent cohort. First, patients take a loading dose. During the following weeks of the study (starting at week 2), the dose was reduced and patients were on a maintenance dose until study completion (Table 1). Patients in Cohort 5 took the same dose throughout the 8-week treatment period.

[0096] Table 1. Dosing regimen for quinacrine

[0097]

[0098] At least 3 patients were enrolled in each cohort. If no patients experienced dose-limiting toxicities (DLTs) after 4 weeks of treatment, 3 additional patients were immediately enrolled in the next cohort. If any patient prematurely discontinued study therapy fro...

Embodiment 2

[0145] Example 2: Statistical Methods and Sample Size Determination Specified by the Protocol

[0146] Statistics and Analytical Protocols With regard to illustrative study objectives such as determination of dose-limiting toxicities, assessment of safety, tolerability and pharmacokinetics, the primary means of analysis were descriptive statistics and graphical representations. Summarize and describe numerical data with the following parameters: number of observations, number of missed observations, minimum, maximum, arithmetic mean, standard deviation, median, mode, 25th percentile, and 75th percentile. For the assessment of qualitative data, the number and percentage age of cases are presented. Measurements / exams performed prior to the first dose of study product (at the Day 1 visit) were considered baseline data. The change from baseline was calculated as the difference between the measurement / examination at Visit Х and the measurement / examination at the Day 1 visit. The ...

Embodiment 3

[0149] Example 3: Treatment

[0150] Oral quinacrine (capsule 50mg). The dosing regimen depends on the dose prescribed to the patient according to the study cohort.

[0151] Group 1

[0152] Days 1-7 Loading dose – 100 mg (2 capsules) three times a day.

[0153] Days 8-56 Maintenance dose – 100 mg (2 capsules) once daily in the morning.

[0154] Group 2

[0155] Days 1-7 Loading dose – 100 mg (2 capsules) three times a day.

[0156] Days 8-56 Maintenance dose – 100mg (2 capsules) in the morning and 100mg (2 capsules) within 4 hours.

[0157] If DLT occurs in the first cohort, reduce the dose in the second cohort to 1 / 2: loading dose 150 mg per day and maintenance dose 50 mg per day.

[0158] Group 3

[0159] Days 1-7 Loading dose – 150 mg (3 capsules) in the morning, 100 mg (2 capsules) in the afternoon, and 100 mg (2 capsules) in the evening.

[0160] Days 8-56 Maintenance dose – 150mg (3 capsules) in the morning and 100mg (2 capsules) within 4 hours.

[0161] Group ...

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Abstract

This invention relates to methods and compositions that are useful for the treatment of various cancers, including primary and secondary liver cancers. The cancers can be metastatic cancer in the liver, or cancers that have metastasized from liver. The invention relates to, in part, uses of quinacrine in the manufacture of a medicament for treatment-resistant liver cancer.

Description

[0001] Cross References to Related Applications [0002] This application claims the benefit of US Provisional Patent Application No. 61 / 954,342, filed March 17, 2014, which is hereby incorporated by reference in its entirety. field of invention [0003] The present invention relates to methods and compositions for the treatment of various cancers including liver cancer. Background technique [0004] Liver cancer is the fifth most common cancer and the third most common cause of cancer-related death worldwide. Liver cancer is usually treated via surgical resection or, when surgery is not considered, via chemotherapy, chemoembolization, or radiation therapy. However, surgical resection is sometimes not indicated due to tumor size or location and concurrent liver disease (such as advanced cirrhosis). Furthermore, even when surgical resection is feasible, the tumor recurs / recurs at five years after resection making it worse in 70% of cases. HCC treatment is complicated by th...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A99Z99/00
CPCA61K31/44A61K31/473A61K2300/00
Inventor 安德烈·列昂诺夫罗马·伊万诺夫柏丽娜·希皮格斯卡娅
Owner 英丘伦股份有限公司
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