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

NCT02691975 | Unknown Phase 1

• 1 other identifier: SHR3680-001
• Study Type: interventional
• Target: 197
• Locations: 1 country
• Sites: 12

Brief 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.

Conditions

Hormone Refractory Prostate Cancer; Metastatic Prostate Carcinoma

Outcome Measures

Primary Outcomes (2)

• 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

  12 weeks

• Radiological progression-free survival

  For Phase 2 portion of study

  24 months

Secondary Outcomes (8)

• Number of participants with treatment-related adverse events

  24 months

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

  12 weeks

• Time to prostate specific antigen (PSA) progression

  24 months

• Objective response rate

  24 months

• Quality of life

  24 months

Study Arms (1)

SHR3680

EXPERIMENTAL

Tablet

Drug: SHR3680

Interventions

SHR3680 DRUG

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

SHR3680

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (12)

Beijing Hosptial

Beijing, Beijing Municipality, China

Location

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Location

Chongqing Cancer Hospital

Chongqing, Chongqing Municipality, China

Location

Henan Cancer Hospital

Zhenzhou, Henan, China

Location

Hunan Cancer Hospital

Changsha, Hunan, China

Location

Jiangsu Cancer Hospital

Nanjing, Jiangsu, China

Location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

Huadong Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, China

Location

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, China

Location

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, China

Location

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Location

Related Publications (1)

• 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.

  PMID: 35241087 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Dingwei Ye, M.D.

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2016
• First Posted: February 25, 2016
• Study Start: April 12, 2016
• Primary Completion: December 1, 2020
• Study Completion: June 1, 2021
• Last Updated: May 13, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (12)