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Prostate Cancer Castration-resistant Prostate CancerPhase 1NCT04108247

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

A Phase 1 study testing Abiraterone+SHR3162 in people with Prostate Cancer Castration-resistant Prostate Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Abiraterone+SHR3162
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
1 siteChina
Study dates
26 Sep 2019to Jun 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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performance of any study-related procedure not part of normal medical care,with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care；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

Who cannot join

  • 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；
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  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Hunan Cancer Hospital

    Changsha, Hunan

Other trials in China

About this study

Official title: 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.

Read the 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).

Being tested
Abiraterone+SHR3162
Keywords
Castration-resistant Prostate Cancer, Abiraterone, SHR3162

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Abiraterone+SHR3162Drug

    Participants will receive Abiraterone combined with SHR3162 orally

Study groups in NCT04108247
Study groupRoleWhat they receive
Abiraterone+SHR3162ExperimentalNot described
Receives: Drug: Abiraterone+SHR3162

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. AE

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

    Measured: Approximately 24 months

  2. Area Under the Curve (AUC)

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

    Measured: Approximately 12 months

  3. Maximum Observed Plasma Concentration (Cmax)

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

    Measured: Approximately 12 months

  4. Minimum Observed Plasma Concentration (Cmin)

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

    Measured: Approximately 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Sep 2019
  2. Study start26 Sep 2019
  3. Primary completionJun 2023 (estimated)
  4. Study completionJun 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04108247
Sponsor's protocol ID
SHR3162-ABI-I-101
Status last verified
Jul 2022
First submitted
26 Sep 2019
Last updated
7 Jul 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Dai T, Xu Z, Wang H, Han W, Zhang D, Tang K, Wang X, Huang J, He C, Zhou X, Zhang D, Yang C. Pharmacokinetics, safety, and efficacy of fuzuloparib in combination with abiraterone acetate and prednisone in patients with metastatic castration-resistant prostate cancer: a phase 1 dose escalation and expansion study. BMC Cancer. 2026 Jun 25. doi: 10.1186/s12885-026-16182-0. Online ahead of print.

    PubMed 42351007

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Abiraterone+SHR3162 in people with Prostate Cancer Castration-resistant Prostate Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AE (time frame: Approximately 24 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04108247, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2022.

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