Formulations of milciclib and therapeutic combinations of the same for use in the treatment of cancer
Inventors
Assignees
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Publication Number
US-10758541-B2
Publication Date
2020-09-01
Expiration Date
Abstract
This application relates to methods of treating and/or preventing cancer (e.g., non-small cell lung cancer, renal cell carcinoma, hepatocellular carcinoma, thyroid carcinoma, colorectal cancer, gastrointestinal stromal tumors, breast cancer, prostate cancer, pancreatic cancer, or thymoma) in patients in need thereof comprising administering to the patient a therapeutically effective amount of a CDK inhibitor (e.g., milciclib) in combination with a therapeutically effective amount of another anticancer drug (e.g., sorafenib, lenvatinib, regorafenib, sunitinib, nivolumab, gemcitabine, and palbociclib).
Core Innovation
The invention is directed to a method of treating liver cancer in a patient in need thereof by administering milciclib, or a pharmaceutically acceptable salt, isomer, or tautomer thereof, together with a therapeutically effective amount of another anticancer drug. In particular, the other anticancer drug is selected from sorafenib, lenvatinib, regorafenib, or pharmaceutically acceptable salts thereof. The approach addresses treatment of liver cancer through combination therapy using milciclib with an additional anticancer agent.
The problem described is the need for improved therapeutic approaches for liver cancer, including hepatocellular carcinoma, by using combinations of anticancer drugs rather than a single agent. The combination includes milciclib with specified kinase-targeted and anticancer agents such as sorafenib, lenvatinib, or regorafenib as therapeutically effective components of the treatment.
In hepatocellular carcinoma, the invention further specifies combination administration of milciclib with sorafenib and provides a defined dosing structure for milciclib and, in some embodiments, dosing alternatives for sorafenib. The disclosed treatment can include formulation options and administration timing concepts such as simultaneous and sequential dosing, including temporal proximity, and may be implemented with unit dosage forms such as oral tablets or capsules, including controlled release.
Claims Coverage
The provided material includes three independent claims, focused on combination treatment of liver cancer and hepatocellular carcinoma using milciclib with selected anticancer drugs. Across the independent claims, the inventive features concentrate on selecting the companion drug(s) and defining therapeutically effective combination administration for the specified cancer indication(s).
Milciclib combination treatment of liver cancer with sorafenib, lenvatinib, or regorafenib
A method of treating liver cancer in a patient in need thereof, comprising administering a therapeutically effective amount of milciclib (or a pharmaceutically acceptable salt, isomer, or tautomer thereof) in combination with a therapeutically effective amount of another anticancer drug, wherein the other anticancer drug is sorafenib, lenvatinib, regorafenib, or a pharmaceutically acceptable salt thereof.
Milciclib plus sorafenib for hepatocellular carcinoma
A method of treating hepatocellular carcinoma in a patient in need thereof comprising administering a therapeutically effective amount of milciclib (or a pharmaceutically acceptable salt, isomer, or tautomer thereof), in combination with a therapeutically effective amount of sorafenib (or a pharmaceutically acceptable salt, isomer, or tautomer thereof).
Defined daily sorafenib and daily milciclib dosing for hepatocellular carcinoma
A method of treating hepatocellular carcinoma in a patient in need thereof, comprising administering to the patient sorafenib at 200, 400, or 800 mg/day and milciclib at 50, 75, 100, 125, or 150 mg/day.
Across the independent claims, the core claim coverage is combination therapy in which milciclib is administered with specified anticancer agents (sorafenib, lenvatinib, and/or regorafenib) for liver cancer, including hepatocellular carcinoma. Additional independent-claim coverage in the provided set includes a specific pairing of milciclib with sorafenib for hepatocellular carcinoma and a defined daily dosing range relationship between sorafenib and milciclib.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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