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Methods of diagnosing and treating abiraterone acetate- glucocorticoid -resistant or -sensitive metastatic castration resistant prostate cancer

A technology of abiraterone acetate and glucocorticoids, applied in the field of biomarkers, can solve problems such as complex clinical decision-making

Pending Publication Date: 2019-05-21
JANSSEN PHARMA NV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Thus, clinicians and patients are challenged with multiple treatment options and the possible sequence of administration of these agents, which further complicates clinical decision-making

Method used

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  • Methods of diagnosing and treating abiraterone acetate- glucocorticoid -resistant or -sensitive metastatic castration resistant prostate cancer
  • Methods of diagnosing and treating abiraterone acetate- glucocorticoid -resistant or -sensitive metastatic castration resistant prostate cancer
  • Methods of diagnosing and treating abiraterone acetate- glucocorticoid -resistant or -sensitive metastatic castration resistant prostate cancer

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Embodiment

[0080] The following examples are provided to further describe some of the embodiments disclosed herein. These examples are intended to illustrate, not limit, the disclosed embodiments of the invention.

[0081] Study Design and Treatment

[0082] Two Phase 2 studies, called JPN-201 and JPN-202, were conducted in Japan. JPN-201 and JPN-202 are daily doses of 1000 mg abiraterone acetate plus 10 mg prednisone (AA) in chemotherapy-naïve (JPN-201) and chemotherapy-pretreated (JPN-202) Japanese patients with mCRPC An open-label, multicenter, single-arm Phase 2 study. Patients took orally abiraterone acetate (1000 mg, once a day) at least 1 hour before meals and 2 hours after meals at any time before 10 pm every day. In addition, prednisolone 5 mg was administered orally twice a day at the same time. The 28-day dosing cycle continued until disease progression or unacceptable toxicity was observed.

[0083] The primary endpoint was the proportion of patients achieving a PSA re...

Embodiment approach 1

[0173] Embodiment 1. A method of diagnosing and treating abiraterone acetate-glucocorticoid resistant metastatic castration-resistant prostate cancer in a patient comprising:

[0174] In a patient who has been treated with abiraterone acetate and glucocorticoids, a patient is diagnosed with abiraterone acetate when the level of PSMA, ACADL, NPY, UBE2C, or any combination thereof is elevated in said patient's biological sample Abiraterone-glucocorticoid-resistant metastatic castration-resistant prostate cancer; and

[0175] The diagnosed patient is treated with a therapeutically effective amount of a therapeutic agent other than abiraterone acetate and a glucocorticoid or with abiraterone acetate and a glucocorticoid plus a therapeutically effective amount of an additional therapeutic agent.

Embodiment approach 2

[0176]Embodiment 2. A method of diagnosing and treating abiraterone acetate-glucocorticoid sensitive metastatic castration-resistant prostate cancer in a patient comprising:

[0177] In a patient who has been treated with abiraterone acetate and glucocorticoids, the patient is diagnosed as having Abiraterone acetate-glucocorticoid-sensitive metastatic castration-resistant prostate cancer; and

[0178] The confirmed patient is treated with a therapeutically effective amount of abiraterone acetate and a glucocorticoid.

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Abstract

Disclosed herein are novel biomarkers for detecting resistance and sensitivity to abiraterone acetate-glucocorticoid treatment in a patient having metastatic castration resistant prostate cancer. Alsoprovided are methods of diagnosing and treating abiraterone acetate-glucocorticoid resistant and abiraterone acetate-glucocorticoid sensitive metastatic castration resistant prostate cancer.

Description

[0001] Cross References to Related Applications [0002] This application claims priority to US Provisional Application 62 / 402,196, filed September 30, 2016, the disclosure of which is incorporated herein by reference in its entirety. technical field [0003] This article provides methods for the diagnosis and treatment of abiraterone acetate-glucocorticoid therapy-resistant and abiraterone acetate-glucocorticoid therapy-sensitive metastatic castration-resistant prostate cancer in patients, as well as methods for diagnosing whether a patient has Biomarkers of acquired resistance to abiraterone acetate-glucocorticoid therapy. Background technique [0004] Prostate cancer is the second most common cancer among American men. It is also one of the leading causes of cancer death in men of all races and Hispanics. In 2010, 196,038 men in the United States were diagnosed with prostate cancer, and 28,560 men in the United States died of prostate cancer. The number of prostate ca...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C12Q1/6886
CPCC12Q1/6886C12Q2600/158A61P35/00A61K31/573A61K31/58G01N33/57434G01N2333/90206G01N2333/948G01N2333/9108G01N2333/5755
Inventor W.李K.卡瓦古施R.奥雅玛J.帕特尔D.斯米尔诺夫D.利兹
Owner JANSSEN PHARMA NV
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