- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04108247
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
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Hunan
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Changsha, Hunan, China
- Hunan Cancer Hospital
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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:
- 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
- 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
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 |
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EXPERIMENTAL: Abiraterone+SHR3162
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Participants will receive Abiraterone combined with SHR3162 orally
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Area Under the Curve (AUC)
Time Frame: Approximately 12 months
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The single dose and multiple dose PK will be calculated as data permits including AUC
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Approximately 12 months
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Maximum Observed Plasma Concentration (Cmax)
Time Frame: Approximately 12 months
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The single-dose and multiple dose PK will be calculated as data permits including Cmax
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Approximately 12 months
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Minimum Observed Plasma Concentration (Cmin)
Time Frame: Approximately 12 months
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The single-dose and multiple dose PK will be calculated as data permits including Cmin
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Approximately 12 months
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AE
Time Frame: Approximately 24 months
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The type, frequency, severity, timing, seriousness, and relationship to study therapy
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Approximately 24 months
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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
Additional Relevant MeSH Terms
Other Study ID Numbers
- SHR3162-ABI-I-101
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.
Clinical Trials on Prostate Cancer Castration-resistant Prostate Cancer
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Nuvation Bio Inc.WithdrawnProstate Cancer | Prostate Neoplasm | Cancer of the Prostate | Prostatic Cancer | Castrate Resistant Prostate Cancer | Cancer of Prostate | Castration Resistant Prostatic Cancer | Castration Resistant Prostatic NeoplasmsUnited States
-
Myovant Sciences GmbHRecruitingMetastatic Castration-Resistant Prostate Cancer | Metastatic Castration-Sensitive Prostate Cancer | Non-Metastatic Castration-Resistant Prostate CancerUnited States
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Sidney Kimmel Comprehensive Cancer Center at Johns...Clarus TherapeuticsRecruitingProstate Cancer | Castration-resistant Prostate Cancer | Metastatic Castration-resistant Prostate CancerUnited States
-
Massachusetts General HospitalBayerCompletedProstate Cancer | Castration-resistant Prostate Cancer | Castration-resistant Prostate Cancer Metastatic to BoneUnited States
-
Universität des SaarlandesRecruitingProstate Cancer Metastatic | Advanced Prostate Carcinoma | Castration Resistant Prostatic CancerGermany
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Vadim S KoshkinEli Lilly and Company; Prostate Cancer FoundationActive, not recruitingCastration-Resistant Prostate Carcinoma | Stage IV Prostate Cancer AJCC v8 | Stage IVA Prostate Cancer AJCC v8 | Stage IVB Prostate Cancer AJCC v8 | Metastatic Castration-resistant Prostate Cancer | Metastatic Prostate Adenocarcinoma | Metastatic Castration-resistant Prostate CarcinomaUnited States
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Janux TherapeuticsRecruitingProstate Cancer | Metastatic Castration-resistant Prostate Cancer | Castration Resistant Prostatic CancerUnited States, Australia
-
Rohan GarjeJanssen Scientific Affairs, LLCNot yet recruitingCastration-resistant Prostate Cancer | Metastatic Prostate Cancer | Metastatic Castration-resistant Prostate CancerUnited States
-
Astellas Pharma IncPfizerCompletedCastration-resistant Prostate CancerJapan
-
Herlev and Gentofte HospitalBristol-Myers SquibbRecruitingProstate Cancer Metastatic | Metastatic Castration-resistant Prostate Cancer | Castrate Resistant Prostate Cancer | Prostate Cancer Stage IVDenmark
Clinical Trials on Abiraterone+SHR3162
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Jiangsu HengRui Medicine Co., Ltd.UnknownHealthy Adult Male and Female Volunteers
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Atridia Pty Ltd.Completed
-
Atridia Pty Ltd.CompletedProstate Cancer | NeoplasmAustralia
-
Atridia Pty Ltd.Completed
-
Jiangsu HengRui Medicine Co., Ltd.UnknownProstate Cancer | Castration-resistant Prostate CancerChina
-
Jiangsu HengRui Medicine Co., Ltd.UnknownAdvanced Pancreatic CancerChina
-
Jiangsu HengRui Medicine Co., Ltd.Recruiting
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Jiangsu HengRui Medicine Co., Ltd.RecruitingMetastatic Castration-Resistant Prostate Cancer (mCRPC)Korea, Republic of, United States, Spain, France, Belgium, China, Taiwan, United Kingdom, Australia, Czechia, Hungary, Poland, Russian Federation
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Jiangnan UniversityAffiliated Hospital of Jiangnan UniversityRecruitingCastration-resistant Prostate CancerChina
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Janssen Research & Development, LLCCompleted