Prostate CancerPhase 1/2NCT03741712
A Study of SHR2554 Alone or in Combination With SHR3680 in the Treatment of mCRPC
A Phase 1/2 study testing SHR3680 and SHR2554 in people with Prostate Cancer and Castration-resistant Prostate Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
The aim of this trial is to study the tolerance, pharmacokinetics (PK) and efficacy of SHR2554 alone or in combination with SHR3680 in the treatment of patients with metastatic Castration Resistant Prostate Cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Castration-resistant Prostate Cancer
- What is being tested?
- SHR3680 and SHR2554
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteChina
- Study dates
- 20 Nov 2018to 8 Dec 2020
- Phase
- Phase 1/2
- 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;
- 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performance of any study-related procedure not part of normal medical care,with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
Who cannot join
- Have received any anti-tumor therapy in the past 4 weeks,including radiotherapy, chemotherapy, operation, targeted therapy, immunotherapy, and endocrinotherapy;
- Planned to initiate any other anti-tumor therapies during the study;
- Unable to swallow, chronic diarrhea and intestinal obstruction, or the presence of a variety of other factors that affect drug use and absorption;
- Clinically significant cardiovascular diseases;
- History of seizure or certain conditions that may predispose to seizure;
- Severe concurrent disease and infection that, in the judgment of the investigator, would make the patient inappropriate for enrollment.
Trial locations and contacts
1 site in 1 country.
China1 site
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality
About this study
Official title: A Phase I/II,Open-Label,Does-Escalation and -Expansion, Safety,Pharmacokinetics and Efficacy Study of SHR2554 Alone or in Combination With SHR3680 in the Treatment of Patients With Metastatic Castration Resistant Prostate Cancer
The aim of this trial is to study the tolerance, pharmacokinetics (PK) and efficacy of SHR2554 alone or in combination with SHR3680 in the treatment of patients with metastatic Castration Resistant Prostate Cancer.
Read the detailed description
This is a multicenter, open, non-randomized and dose-escalating and -expansion Phase I/II trial and it studies the tolerance, PK and efficacy of SHR2554 alone or in combination with SHR3680 in the treatment of patients with metastatic Castration Resistant Prostate Cancer. The Phase I part is a dose-escalating study including Ia (dose-escalation monotherapy) and Ib (dose-escalation combination therapy). Approximately 18-30 patients in Phase Ia will only receive one of five dose levels of orally SHR2554. Approximately 30~48 patients in Phase Ib trial will receive SHR2554 combined with SHR3680, in which 2~3 different dose levels of SHR2554 will be selected based on the result of the Phase Ia. Phase II part is a dose-expansion study. Primary endpoints of the study are dose-limiting tolerance (DLT), maximum-tolerated dose (MTD) and prostate specific antigen (PSA) response rate.
- Being tested
- SHR3680, SHR2554
- Keywords
- Castration-resistant Prostate Cancer, SHR2554, SHR3680
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR3680Drug
Tablet. Specifications of 80mg
SHR2554Drug
Tablet. Specifications of 50mg and 200mg
| Study group | Role | What they receive |
|---|---|---|
| SHR2554 | Experimental | Participants will receive SHR2554 orally Receives: Drug: SHR2554 |
| SHR2554+SHR3680 | Experimental | Participants will receive SHR2554 combined with SHR3680 orally Receives: Drug: SHR3680; Drug: SHR2554 |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLT
A DLT is any of the predefined set of unacceptable adverse events observed and at least possibly related to investigational agents
Measured: Approximately 12 months
MTD
The first cycle DLTs will be utilized to determine the MTD and future dose escalations or de-escalations The first cycle DLTs will be utilized to determine the MTD and future dose escalations or de-escalations
Measured: Approximately 12 months
PSA response rate
After the continuous therapy from randomisation to the end of the 12 weeks, the ratio of patients whose levels of PSA decreased more than 50%
Measured: Approximately 12 weeks
Secondary outcomes (5)
Time to PSA progression
Time from randomisation to the first time of PSA progression according to the criteria of the Prostate Cancer Clinical Trials Working Group 3 （PCWG3)
Measured: Approximately 70 months
Objective response rate (ORR)
The percentage of subjects with measureable disease at baseline who achieved a complete or partial response in their soft tissue disease using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria
Measured: Approximately 70 months
Under the Curve (AUC)
The single dose and multiple dose PK will be calculated as data permits including Area AUC
Measured: Approximately 12 months
Maximum Observed Plasma Concentration (Cmax)
The single-dose and multiple dose PK will be calculated as data permits including Cmax
Measured: Approximately 12 months
Adverse events (AE)
The type, frequency, severity, timing, seriousness, and relationship to study therapy
Measured: Approximately 70 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2018
- Study start20 Nov 2018
- Primary completion30 Sep 2019
- Study completion8 Dec 2020
Why it stopped: According to the available data from the trial，the sponsor determined to terminate this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dingwei Ye, M.D., Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03741712
- Sponsor's protocol ID
- SHR2554-SHR3680-I/II-102
- Status last verified
- Jul 2018
- First submitted
- 17 Oct 2018
- Last updated
- 5 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II,Open-Label,Does-Escalation and -Expansion, Safety,Pharmacokinetics and Efficacy Study of SHR2554 Alone or in Combination With SHR3680 in the Treatment of Patients With Metastatic Castration Resistant Prostate Cancer
- ClinicalTrials.gov ID
- NCT03741712
- Acronym / sponsor ID
- SHR2554-SHR3680-I/II-102
- Keywords
- Castration-resistant Prostate Cancer, SHR2554, SHR3680
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: According to the available data from the trial，the sponsor determined to terminate this study.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Nov 2018 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 8 Dec 2020 (actual)
- First posted
- 15 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this trial is to study the tolerance, pharmacokinetics (PK) and efficacy of SHR2554 alone or in combination with SHR3680 in the treatment of patients with metastatic Castration Resistant Prostate Cancer.
Detailed description
This is a multicenter, open, non-randomized and dose-escalating and -expansion Phase I/II trial and it studies the tolerance, PK and efficacy of SHR2554 alone or in combination with SHR3680 in the treatment of patients with metastatic Castration Resistant Prostate Cancer. The Phase I part is a dose-escalating study including Ia (dose-escalation monotherapy) and Ib (dose-escalation combination therapy). Approximately 18-30 patients in Phase Ia will only receive one of five dose levels of orally SHR2554. Approximately 30~48 patients in Phase Ib trial will receive SHR2554 combined with SHR3680, in which 2~3 different dose levels of SHR2554 will be selected based on the result of the Phase Ia. Phase II part is a dose-expansion study. Primary endpoints of the study are dose-limiting tolerance (DLT), maximum-tolerated dose (MTD) and prostate specific antigen (PSA) response rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SHR2554 | Experimental | Drug: SHR2554Participants will receive SHR2554 orally |
| SHR2554+SHR3680 | Experimental | Drug: SHR3680, Drug: SHR2554Participants will receive SHR2554 combined with SHR3680 orally |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically or cytologically confirmed prostate cancer;
- 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;
Key exclusion criteria (6 listed)
- Have received any anti-tumor therapy in the past 4 weeks,including radiotherapy, chemotherapy, operation, targeted therapy, immunotherapy, and endocrinotherapy;
- Planned to initiate any other anti-tumor therapies during the study;
- Unable to swallow, chronic diarrhea and intestinal obstruction, or the presence of a variety of other factors that affect drug use and absorption;
- Clinically significant cardiovascular diseases;
- History of seizure or certain conditions that may predispose to seizure;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHR3680Tablet. Specifications of 80mg | Drug | SHR2554+SHR3680 |
| SHR2554Tablet. Specifications of 50mg and 200mg | Drug | SHR2554, SHR2554+SHR3680 |
Primary outcome
DLT
Time frame: Approximately 12 months
A DLT is any of the predefined set of unacceptable adverse events observed and at least possibly related to investigational agents
MTD
Time frame: Approximately 12 months
The first cycle DLTs will be utilized to determine the MTD and future dose escalations or de-escalations The first cycle DLTs will be utilized to determine the MTD and future dose escalations or de-escalations
PSA response rate
Time frame: Approximately 12 weeks
After the continuous therapy from randomisation to the end of the 12 weeks, the ratio of patients whose levels of PSA decreased more than 50%
5 secondary outcomes
Time to PSA progression
Time frame: Approximately 70 months
Objective response rate (ORR)
Time frame: Approximately 70 months
Under the Curve (AUC)
Time frame: Approximately 12 months
Maximum Observed Plasma Concentration (Cmax)
Time frame: Approximately 12 months
Adverse events (AE)
Time frame: Approximately 70 months
Results and safety
The study was stopped early (reason given: According to the available data from the trial，the sponsor determined to terminate this study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dingwei Ye, M.D. principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SHR3680 and SHR2554 in people with Prostate Cancer and 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 7 inclusion and 6 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: stopped early, as of the sponsor's last update on 5 Feb 2021. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: According to the available data from the trial，the sponsor determined to terminate 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?
DLT (time frame: Approximately 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Feb 2021.