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

July 6, 2022 updated by: Jiangsu HengRui Medicine Co., Ltd.

A Phase I Clinical Study of Abiraterone Combined With SHR3162 in the Treatment of Metastatic Castration-resistant Prostate Cancer

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.

Study Overview

Status

Active, not recruiting

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Hunan
      • Changsha, Hunan, China
        • Hunan Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. Histologically or cytologically confirmed prostate cancer; does not suggest neuroendocrine or small cell characteristics
  2. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1;
  3. Radiographic evidence of metastasis;
  4. 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;
  5. Evidence of prostate cancer progression under the sustained therapy of LHRHA or bilateral orchiectomy;
  6. Adequate hepatic, renal, heart, and hematological functions;
  7. 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;
  8. Expected to survive for at least 3 months;

Exclusion Criteria:

  1. Have received any anti-tumor therapy in the past 4 weeks,including radiotherapy, chemotherapy, operation, targeted therapy, immuntherapy, and endocrinotherapy;
  2. 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.
  3. The first study used phytopharmaceuticals that may reduce PSA levels within 4 weeks prior to dosing
  4. Plan to receive any other anti-tumor treatment during this trial;
  5. Subjects have contraindications to prednisone, such as active infections or other conditions
  6. Subjects present any chronic condition requiring treatment with corticosteroids at doses greater than prednisone 5 mg, BID;
  7. 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.
  8. 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.
  9. 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;
  10. Imaging diagnosis of brain tumor lesions
  11. history of pituitary or adrenal dysfunction
  12. 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)
  13. 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
  14. History of immunodeficiency (including HIV positive, other acquired, congenital immunodeficiency disease) or organ transplant history
  15. 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;
  16. Habitual constipation or diarrhea, irritable bowel syndrome, inflammatory bowel disease; abdominal fistula, gastrointestinal perforation or abdominal abscess within 6 months before the first dose
  17. Drinking alcohol during the first 6 months of alcohol or screening, ie drinking more than 14 units of alcohol per week
  18. Habitual drinking of grapefruit juice or excessive tea, coffee and / or caffeinated beverages, and can not be withdrawn during the trial
  19. 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
  20. Patients who are unwilling to take effective contraceptive measures during the entire study period and within 3 months after the last dose

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Abiraterone+SHR3162
Participants will receive Abiraterone combined with SHR3162 orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Approximately 12 months
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
Approximately 12 months
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
Approximately 12 months
AE
Time Frame: Approximately 24 months
The type, frequency, severity, timing, seriousness, and relationship to study therapy
Approximately 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 26, 2019

Primary Completion (ANTICIPATED)

June 1, 2023

Study Completion (ANTICIPATED)

June 1, 2023

Study Registration Dates

First Submitted

September 26, 2019

First Submitted That Met QC Criteria

September 27, 2019

First Posted (ACTUAL)

September 30, 2019

Study Record Updates

Last Update Posted (ACTUAL)

July 7, 2022

Last Update Submitted That Met QC Criteria

July 6, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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