A Study of Abiraterone in Combination With SHR3162 in the Treatment of mCRPC

NCT04108247 | Unknown Phase 1

• 1 other identifier: SHR3162-ABI-I-101
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer Castration-resistant Prostate Cancer

Keywords

Castration-resistant Prostate Cancer; Abiraterone; SHR3162

Outcome Measures

Primary Outcomes (4)

• AE

  The type, frequency, severity, timing, seriousness, and relationship to study therapy

  Approximately 24 months

• Area Under the Curve (AUC)

  The single dose and multiple dose PK will be calculated as data permits including AUC

  Approximately 12 months

• Maximum Observed Plasma Concentration (Cmax)

  The single-dose and multiple dose PK will be calculated as data permits including Cmax

  Approximately 12 months

• Minimum Observed Plasma Concentration (Cmin)

  The single-dose and multiple dose PK will be calculated as data permits including Cmin

  Approximately 12 months

Study Arms (1)

Abiraterone+SHR3162

EXPERIMENTAL

Drug: Abiraterone+SHR3162

Interventions

Abiraterone+SHR3162 DRUG

Participants will receive Abiraterone combined with SHR3162 orally

Abiraterone+SHR3162

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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performance of any study-related procedure not part of normal medical care,with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care；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；

You may not qualify if:

• 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;

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Hunan Cancer Hospital

Changsha, Hunan, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2019
• First Posted: September 30, 2019
• Study Start: September 26, 2019
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: July 7, 2022

Record last verified: 2022-07

Locations

CN (1)