Status:
UNKNOWN
A Study of Abiraterone in Combination With SHR3162 in the Treatment of mCRPC
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Prostate Cancer Castration-resistant Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE1
Brief Summary
The aim of this trial is to evaluate the Drug-Drug interaction with Abiraterone combined with SHR3162 in the Metastatic Castration Resistant Prostate Cancer Patients.
Detailed Description
This is a multicenter, open-label Phase I trial and the aim of this trial is to evaluate the drug-drug interaction and safety with SHR3162 combined with Abiraterone in Metastatic Castration Resistant ...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed prostate cancer; does not suggest neuroendocrine or small cell characteristics
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1;
- Radiographic evidence of metastasis;
- Sustained therapy of luteinizing hormone-releasing hormone analogue(LHRHA)or received bilateral orchiectomy; patients who did not receive bilateral orchiectomy are willing to receive sustained therapy of LHRHA;
- Evidence of prostate cancer progression under the sustained therapy of LHRHA or bilateral orchiectomy;
- Adequate hepatic, renal, heart, and hematological functions;
- Patients have given voluntary written informed consent before performance of any study-related procedure not part of normal medical care,with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care；
- Expected to survive for at least 3 months；
Exclusion
- Have received any anti-tumor therapy in the past 4 weeks,including radiotherapy, chemotherapy, operation, targeted therapy, immuntherapy, and endocrinotherapy;
- As a subject to participate in other drug clinical trials, the last test drug was administered within 4 weeks from the first dose of the study drug.
- The first study used phytopharmaceuticals that may reduce PSA levels within 4 weeks prior to dosing
- Plan to receive any other anti-tumor treatment during this trial;
- Subjects have contraindications to prednisone, such as active infections or other conditions
- Subjects present any chronic condition requiring treatment with corticosteroids at doses greater than prednisone 5 mg, BID；
- The investigators judged severe bone damage caused by tumor bone metastasis, including severely controlled bone pain, pathological fractures and spinal cord compressions that occurred in the last 6 months or are expected to occur in the near future.
- Uncontrolled high blood pressure (systolic blood pressure 160 mmHg or diastolic blood pressure 95 mmHg). If blood pressure can be effectively controlled by antihypertensive therapy, subjects with a history of hypertension are allowed to participate in the study.
- Study of active heart disease within 6 months prior to the first dose, including: severe/unstable angina, myocardial infarction, symptomatic congestive heart failure, left ventricular ejection fraction \<50%, and room for medication Arrhythmia；
- Imaging diagnosis of brain tumor lesions
- history of pituitary or adrenal dysfunction
- Study of other malignant tumors within 5 years prior to the first dose (in situ cancer with complete remission and excluding malignant tumors with slow progress)
- Patients with active HBV or HCV infection (HBV virus copy number ≧104 copies/mL, HCV virus copy number ≧103 copies/mL), or active syphilis infection
- History of immunodeficiency (including HIV positive, other acquired, congenital immunodeficiency disease) or organ transplant history
- It is possible to use any potent drug that inhibits or induces the liver drug metabolism enzyme (CYP3A4) during the 14 days prior to the first dose or during treatment;
- Habitual constipation or diarrhea, irritable bowel syndrome, inflammatory bowel disease; abdominal fistula, gastrointestinal perforation or abdominal abscess within 6 months before the first dose
- Drinking alcohol during the first 6 months of alcohol or screening, ie drinking more than 14 units of alcohol per week
- Habitual drinking of grapefruit juice or excessive tea, coffee and / or caffeinated beverages, and can not be withdrawn during the trial
- Daily smoking in the first 3 months of the screening period is greater than 10 or habitual use of nicotine-containing products, and can not be withdrawn during the trial period
- Patients who are unwilling to take effective contraceptive measures during the entire study period and within 3 months after the last dose
Key Trial Info
Start Date :
September 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2023
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT04108247
Start Date
September 26 2019
End Date
June 1 2023
Last Update
July 7 2022
Active Locations (1)
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1
Hunan Cancer Hospital
Changsha, Hunan, China