A Phase I Clinical Study of Abiraterone Combined With SHR3162 in the Treatment of Metastatic Castration-resistant Prostate Cancer
Overview
- Phase
- Phase 1
- Intervention
- Abiraterone+SHR3162
- Conditions
- Prostate Cancer Castration-resistant Prostate Cancer
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Enrollment
- 39
- Locations
- 1
- Primary Endpoint
- AE
- Last Updated
- 3 years ago
Overview
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 Prostate Cancer Patients. The trial is a dose-escalation and -expansion study. Approximately 35\~38 patients in will receive fixed- dose of orally Abiraterone and only one of two dose levels of orally SHR3162. The Primary endpoints are incidence of adverse events(AE) and PK characteristics. The secondary endpoints are efficacy and recommended phase 2 dose(RP2D).
Investigators
Eligibility Criteria
Inclusion Criteria
- •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performance of any study-related procedure not part of normal medical care,with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care；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 Criteria
- •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
Arms & Interventions
Abiraterone+SHR3162
Intervention: Abiraterone+SHR3162
Outcomes
Primary Outcomes
AE
Time Frame: Approximately 24 months
The type, frequency, severity, timing, seriousness, and relationship to study therapy
Area Under the Curve (AUC)
Time Frame: Approximately 12 months
The single dose and multiple dose PK will be calculated as data permits including AUC
Maximum Observed Plasma Concentration (Cmax)
Time Frame: Approximately 12 months
The single-dose and multiple dose PK will be calculated as data permits including Cmax
Minimum Observed Plasma Concentration (Cmin)
Time Frame: Approximately 12 months
The single-dose and multiple dose PK will be calculated as data permits including Cmin