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Hormone Refractory Prostate CancerPhase 1/2NCT02691975

A Safety and Efficacy Study of SHR3680 in Metastatic Castration-Resistant Prostate Cancer Patients

A Phase 1/2 study testing SHR3680 in people with Hormone Refractory Prostate Cancer and Metastatic Prostate Carcinoma, run by Jiangsu HengRui Medicine Co., Ltd. at 12 sites 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 The sponsor has not verified this record for over two years, so it may be out of date.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

This study evaluates the tolerability, safety, pharmacokinetics and efficacy of SHR3680 in patients with metastatic castration-resistant prostate cancer (mCPRC). All participants will receive SHR3680. Read more about this study

Who is it for?
Ages 18 to 80 years, men only
What is being tested?
SHR3680
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
197 participants
Where
12 sitesChina
Study dates
12 Apr 2016to 1 Jun 2021
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 to 80 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ECOG performance scale 0 - 1.
  • Life expectancy of more than 6 months.
  • Histologically or cytologic confirmed prostate adenocarcinoma without neuroendocrine differentiation or small cell features
  • Ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) analogue or orchiectomy
  • Evidence of prostate cancer progression by radiographic or PSA criteria
  • Radiological evidence of distant metastatic lesions
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  • Serum testosterone level < 1.7 nmol/L (50 ng/dL) at the screening visit
  • Adequate hepatic, renal, heart, and hematologic functions (platelets > 80 × 10e9/L, neutrophil > 1.5 × 10e9/L, Hb >90 g/L,total bilirubin and creatinine within upper limit of normal(ULN), and serum transaminase≤1.5×the ULN).
  • Signed and dated informed consent.Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure.

Who cannot join

  • Treatment with androgen receptor antagonists, 5-alpha reductase inhibitors, estrogens, or chemotherapy within 4 weeks of enrollment or plans to initiate treatment with any of these drugs during the study
  • Prior treatment with enzalutamide, abiraterone, or ketoconazole for prostate cancer
  • History of seizure or any conditions that may predispose to seizure
  • Concurrent or planned treatment with corticosteroids, medications known to have seizure potential, or herbal products known to decrease PSA levels
  • Planned to initiate any other anti-tumor therapies during the study
  • Less than 4 weeks from the last clinical trial
Show all 10Show fewer
  • Evidence of brain metastasis or primary tumors
  • Clinically significant cardiovascular diseases
  • Abuse of alcohol or drugs
  • Severe concurrent disease, infection, or bone metastasis that, in the judgment of the investigator, would make the patient inappropriate for enrollment

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

China12 sites

  • Beijing Hosptial

    Beijing, Beijing Municipality

  • Chinese PLA General Hospital

    Beijing, Beijing Municipality

  • Hunan Cancer Hospital

    Changsha, Hunan

  • Chongqing Cancer Hospital

    Chongqing, Chongqing Municipality

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang

  • Jiangsu Cancer Hospital

    Nanjing, Jiangsu

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

  • Huadong Hospital Affiliated to Fudan University

    Shanghai, Shanghai Municipality

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, Tianjin Municipality

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xi’an, Shanxi

  • Henan Cancer Hospital

    Zhenzhou, Henan

Other trials in China

About this study

Official title: A Phase I/II, Open-Label, Dose-Escalation and -Expansion, Safety, Pharmacokinetics and Efficacy Study of SHR3680 in Patients With Metastatic Castration-Resistant Prostate Cancer

This study evaluates the tolerability, safety, pharmacokinetics and efficacy of SHR3680 in patients with metastatic castration-resistant prostate cancer (mCPRC). All participants will receive SHR3680.

Read the detailed description

Androgenic signaling plays a pivotal role in the development of prostate cancer. Androgen deprivation therapy is the mainstay treatment for this cancer in the metastatic setting, but the disease eventually develops to castration-resistant prostate cancer (CRPC) mainly due to the overexpression of androgen receptors (AR) and continued AR activation.

SHR3680 is a novel strong AR antagonist. By competitively binding to AR, SHR3680 inhibits androgen-mediated translocation of AR to the nucleus, binding of AR to Deoxyribonucleic acid (DNA), and finally the transcription of AR target genes, thus possibly resulting in a specific and strong anti-tumor effect on prostate cancer. Unlike first-generation AR antagonists (e.g. bicalutamide), which undergoes an antagonist-to-agonist switch to stimulate AR in the setting of AR overexpression in CRPC, SHR3680 is a full antagonist of AR and thus it is supposed to be more effective for the treatment of CRPC.

Being tested
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

    SHR3680 is administrated orally, qd, 28 days as one cycle. Patients may continue SHR3680 until disease progression or unacceptable toxicity.

Study groups in NCT02691975
Study groupRoleWhat they receive
SHR3680ExperimentalTablet
Receives: Drug: SHR3680

What is being measured

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

  1. Maximum tolerated dose (MTD)

    For Phase 1 portion of study; maximum-tolerated dose (MTD) will be defined as the maximum dose level at which no more than one out of three subjects experience a dose-limiting toxicity (DLT) within the first 12 weeks of multiple dosing

    Measured: 12 weeks

  2. Radiological progression-free survival

    For Phase 2 portion of study

    Measured: 24 months

Secondary outcomes (8)

  1. Number of participants with treatment-related adverse events

    Adverse events are assessed by CTCAE v4.0

    Measured: 24 months

  2. The percentage of patients reaching at least a 50% reduction in prostate specific antigen (PSA) as compared to baseline at 12 weeks

    Measured: 12 weeks

  3. Time to prostate specific antigen (PSA) progression

    Prostate specific antigen (PSA) progression is defined by the Prostate Cancer Clinical Trials Working Group (PCWG2) criteria.

    Measured: 24 months

  4. Objective response rate

    Measured: 24 months

  5. Quality of life

    Brief Pain Inventory (Short Form), Functional Assessment of Cancer Therapy-Prostate (v4.0)

    Measured: 24 months

  6. Peak plasma concentration (Cmax)

    Measured: 12 weeks

  7. Area under the plasma concentration versus time curve (AUC）

    Measured: 12 weeks

  8. T1/2 (Half-life)

    The time required for the plasma concentration of a drug to be reduced by 50%

    Measured: 12 weeks

Timeline

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

  1. First posted25 Feb 2016 (estimated)
  2. Study start12 Apr 2016
  3. Primary completion1 Dec 2020 (estimated)
  4. Study completion1 Jun 2021 (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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
197 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02691975
Sponsor's protocol ID
SHR3680-001
Status last verified
May 2020
First submitted
17 Feb 2016
Last updated
13 May 2020
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Qin X, Ji D, Gu W, Han W, Luo H, Du C, Zou Q, Sun Z, He C, Zhu S, Chong T, Yao X, Wan B, Yang X, Bai A, Jin C, Zou J, Ye D. Activity and safety of SHR3680, a novel antiandrogen, in patients with metastatic castration-resistant prostate cancer: a phase I/II trial. BMC Med. 2022 Mar 4;20(1):84. doi: 10.1186/s12916-022-02263-x.

    PubMed 35241087

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing SHR3680 in people with Hormone Refractory Prostate Cancer and Metastatic Prostate Carcinoma, run by Jiangsu HengRui Medicine Co., Ltd. at 12 sites 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 9 inclusion and 10 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 13 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites 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?

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?

Maximum tolerated dose (MTD) (time frame: 12 weeks). The study lists 2 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 NCT02691975, 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 13 May 2020.

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