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Methods of treating cancer

A cancer, optional technology, applied in the directions of pharmaceutical formulations, medical preparations without active ingredients, and medical preparations containing active ingredients, etc., can solve the problems of unmet medical needs of patients with advanced cancer

Pending Publication Date: 2020-12-01
NEUPHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Despite significant advances in early detection and multimodal therapy for cancer treatment, there remains an unmet medical need for treating patients with advanced cancer

Method used

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  • Methods of treating cancer
  • Methods of treating cancer
  • Methods of treating cancer

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0223] Example 1. Phase I Study of Exemplary Compounds

[0224] A Phase I study of an exemplary compound of Formula I (such as any one of the compounds listed in Table 1 ) or a pharmaceutically acceptable salt thereof is conducted in locally advanced or metastatic solid tumors.

[0225] The primary objective of the study is to evaluate patients with locally advanced or metastatic solid tumors by intravenous (IV) infusion 3 times a week (Day 1, Day 2, and Day 3 for three weeks, followed by a week off ) safety and tolerability of administered exemplary compounds of formula I, and determining the maximum tolerated dose (MTD) of exemplary compounds of formula I. If the MTD is not reached, the optimal biological dose (OBD) is determined after the Safety Review Committee (SRC) and the investigator discuss the optimal balance of toxicity, pharmacokinetics (PK), pharmacodynamics (PD), and clinical response signals ).

[0226] A secondary objective of this study was to characterize t...

Embodiment 2

[0236] Example 2. Continuous Administration of Exemplary Compounds

[0237] In this proposed study, a similar clinical trial was performed with the exemplary compound of formula I discussed in Example 1, except that the compound was administered continuously for 24 hours on days 1-14, followed by a one week rest. The safety and efficacy of this compound were evaluated as discussed in Example 1.

Embodiment 3

[0238] Example 3. Clinical Trials of Exemplary Compounds

[0239] This example provides results from clinical trials investigating the efficacy of exemplary compounds of Formula I, or pharmaceutically acceptable salts thereof, against various tumor types. Exemplary compounds of Formula I were administered to patients via 2-hour intravenous (IV) infusion once a week for three consecutive weeks. The treatment cycle was defined as 28 days, consisting of 21 days of treatment and 7 days of rest. The number of treatment cycles completed ranged from 1 to 4. Dosages of exemplary compounds of formula I range from 0.08 to 1.0 mg / m 2 . Patients in the study included both men and women. The tumor types studied in this clinical study included colorectal cancer, breast cancer, liver cancer, gastric cancer and non-small cell lung cancer. Efficacy assessments were determined at the last patient visit of the study. The results are shown in Table 2 below.

[0240] Table 2

[0241]

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Abstract

The present invention relates to methods of treating cancer comprising administering a bufalin derivative compound of Formula I, wherein the compound is administered at least once a week for at leasttwo weeks.

Description

[0001] Cross References to Related Applications [0002] This application claims the benefit of priority to U.S. Provisional Patent Application No. 62 / 599,643, filed December 15, 2017. The entire content of this application is hereby incorporated by reference. technical field [0003] The present invention relates to methods and compositions for treating cancer by administering bufalin derivative compounds. Background technique [0004] Despite significant advances in early detection and multimodal therapy for cancer treatment, there remains an unmet medical need for treating patients with advanced cancer. [0005] The traditional Chinese medicine cinobufacini (an injectable form of bufobufacin) is used in China to treat a variety of cancers, including liver, lung, pancreas, and colorectal cancers. Its anticancer activity is attributed to three main steroidal cardiac glycosides: bufalin, resibufogenin and cinobufagin. When tested, bufalin showed potent activity in cancer ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/585A61P31/00
CPCA61K31/585A61P35/00A61P31/00A61K47/12A61K9/0019
Inventor X·钱
Owner NEUPHARMA
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