A Study of SHR3680 in Combination With Docetaxel in the Treatment of mCRPC

NCT04603833 | Unknown Phase 2 DMC

• 1 other identifier: SHR3680-II-203
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this trial is to evaluate SHR3680 combined with Docetaxel to improve Metastatic Castration Resistant Prostate Cancer Patients whether the patient's Time to prostate specific antigen (PSA) progression is superior to SHR3680 or Docetaxel single drug.

Conditions

Prostate Cancer Metastatic

Outcome Measures

Primary Outcomes (2)

• Time to prostate specific antigen (PSA) progression

  Time from randomisation to the first time of PSA progression according to the criterion of PCGW3

  [Time Frame: Approximately 24 months]

• Adverse Event(AE)

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

  [Time Frame: Approximately 24 months]

Secondary Outcomes (7)

• Radiographic Progression Free Survival(rPFS)

  [Time Frame: Approximately 24 months]

• Objective response rate (ORR)

  [Time Frame: Approximately 24 months]

• PSA response rate

  [Time Frame: Approximately 3 months]

• Overall Survival(OS)

  [Time Frame: Approximately 24 months]

• Area Under the Curve (AUC)

  [Time Frame: Approximately 2 months]

Study Arms (3)

SHR3680+Docetaxel

EXPERIMENTAL

Drug: SHR3680+Docetaxel

SHR3680

ACTIVE COMPARATOR

Drug: SHR3680

Docetaxel

ACTIVE COMPARATOR

Drug: Docetaxel

Interventions

SHR3680+Docetaxel DRUG

Participants will receive SHR3680 combined with Docetaxel

SHR3680+Docetaxel

SHR3680 DRUG

Participants will receive SHR3680

SHR3680

Docetaxel DRUG

Participants will receive Docetaxel

Docetaxel

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically confirmed prostate cancer; Unconfirmed neuroendocrine carcinoma or small cell carcinoma;
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1;
• Radiographic evidence of metastasis（CT/MRI/ECT);
• 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；
• Patient has been treated with Abiraterone and treatment failed；Treatment failure is defined as the progression of disease during treatment；

You may not qualify if:

• 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;
• 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;
• Habitual constipation or diarrhea, irritable bowel syndrome, inflammatory bowel disease; abdominal fistula, gastrointestinal perforation or abdominal abscess within 6 months before the first dose;
• Patients who are unwilling to take effective contraceptive measures during the entire study period and within 3 months after the last dose

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, China

RECRUITING

MeSH Terms

Interventions

Docetaxel

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Central Study Contacts

Chunlei Jin, Ph.D.

CONTACT

86-021-23511999; jinchunlei@hrglobe.cn

Qiang Wei, Ph.D.

CONTACT

028-85423237

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2020
• First Posted: October 27, 2020
• Study Start: December 2, 2020
• Primary Completion: October 1, 2022
• Study Completion: December 31, 2022
• Last Updated: February 21, 2021

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)