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Methods of treating CNS tumors with tesetaxel

A technology of tesostatin and tumor, which is applied in the field of treating CNS tumors with tesostatel, which can solve the problems of bad results and so on.

Pending Publication Date: 2021-08-17
DRAGONFLY THERAPEUTICS INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Presence and / or development of CNS metastases generally worsen outcomes in cancer patients including LA / MBC

Method used

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  • Methods of treating CNS tumors with tesetaxel
  • Methods of treating CNS tumors with tesetaxel
  • Methods of treating CNS tumors with tesetaxel

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0097] Example 1: Clinical Research

[0098] Patients with HER2-negative, HR-positive LA / MBC previously treated with taxanes in the neoadjuvant or adjuvant setting were recruited and randomized into one of two treatment groups. Known transfers to CNS are permitted but not required. Additional analyzes of CNS tumor efficacy were performed on patients with CNS tumor metastases.

[0099] Patients in treatment group 1 received 27 mg / m orally on day 1 of a 21-day cycle 2 Tesetaxel, and started on day 1 of a 21-day cycle and ended on day 15, 14 doses of 1,650 mg / m orally 2 The daily dose of capecitabine (825mg / m 2 , twice daily at intervals), beginning with an evening dose on Day 1 of each 21-day cycle and ending with a morning dose on Day 15. Treatment continued in 21-day cycles until a patient's disease progression or unacceptable toxicity was observed.

[0100] Beginning on day 1 of a 21-day cycle and ending on day 15, with 14 doses of 2,500 mg / m 2 Daily dose of capecitab...

Embodiment 2

[0102] Embodiment 2: clinical research

[0103] Elderly patients (≥65 years) with HER2-negative LA / MBC not previously treated with chemotherapy for LA / MBC were assigned to one treatment group without randomization. Inclusion criteria included prior endocrine therapy with or without a CDK 4 / 6 inhibitor, unless endocrine therapy was not specified. Known CNS transfers are allowed but not required.

[0104] On day 1 of each 21-day cycle, use 27 mg / m 2 Tesetaxel monotherapy was administered orally to patients once. Treatment continued in 21-day cycles until documented progressive disease (PD), unacceptable toxicity observed in the patient, or other decision to discontinue treatment.

[0105] The primary endpoint of the study was the investigator-assessed objective response rate using RECIST 1.1 criteria. Secondary endpoints included investigator-assessed progression-free survival and overall survival using RECIST 1.1 criteria. Efficacy on CNS metastasis is measured by CNS ob...

Embodiment 3

[0106] Embodiment 3: clinical research

[0107] Adult patients (≥18 years) with triple-negative LA / MBC who had not received prior chemotherapy for LA or metastatic disease were recruited and randomized into three treatment groups. The patient's most recent biopsy must be negative for HR. Known transfers to CNS are permitted but not required.

[0108] Administer 27 mg / m orally on day 1 of each 21-day cycle to treated patients 2 Tesetaxel, plus one of the following: (A1) Nivolumab (360 mg) IV infusion over 30 minutes on Day 1 of each 21-day cycle; (A2) Nivolumab (360 mg) on ​​Day 1 of each 21-day cycle pembrolizumab (200 mg) intravenously for 30 minutes every day; or (A3) atezolizumab (1200 mg) intravenously for 60 minutes on day 1 of each 21-day cycle (if the first infusion is allowed, all Subsequent infusions can be infused for 30 minutes). Treatment continued in 21-day cycles until documented progressive disease, unacceptable toxicity observed in the patient, or other d...

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Abstract

The present disclosure provides methods for treating a patient with a cancer in the central nervous system, such as a cancer that is a metastasis of a primary cancer, comprising administering tesetaxel and capecitabine to the patient.

Description

[0001] Related Application Cross Reference [0002] This patent application claims the benefit of priority to U.S. Provisional Patent Application No. 62 / 746,926, filed October 17, 2018, and U.S. Provisional Patent Application No. 62 / 811,181, filed February 27, 2019, each of which is incorporated by reference in its entirety This article 。 [0003] Background of the invention [0004] People with cancerous central nervous system (CNS) tumors had a 5-year survival rate of 34 percent for men and 36 percent for women. CNS tumors often arise through the spread of other cancers elsewhere in the body or through metastases to the brain. In adults, secondary (metastatic) CNS tumors are much more common than primary CNS tumors (originating in the CNS itself or tissues close to it). Although any cancer can spread to the brain, the two most common types of spread are breast and lung. [0005] Breast cancer is the most common cancer in women worldwide, with an estimated 2.1 million new ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/357A61K31/7068A61P35/00A61K39/00A61K39/395
CPCA61K31/7068A61P35/04C07K16/2818C07K16/2827A61K39/39558A61K39/39541A61K31/337A61K2300/00A61K31/443A61K9/0053A61K45/06A61K35/00A61K2039/505A61P35/00A61K39/3955
Inventor J·詹姆斯K·唐S·克罗尔J·G·莱姆基S·普菲菲尔J·瓦奇尔卡T·韦
Owner DRAGONFLY THERAPEUTICS INC
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