A Phase II Clinical Study of SHR3680 Combined With Docetaxel in the Treatment of Metastatic Castration-resistant Prostate Cancer Previously Treated With Abiraterone


Condition: Prostate Cancer Metastatic

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04603833

Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  1. Histologically or cytologically confirmed prostate cancer; Unconfirmed neuroendocrine carcinoma or small cell carcinoma;
  2. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1;
  3. Radiographic evidence of metastasis(CT/MRI/ECT);
  4. 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;
  5. Evidence of prostate cancer progression under the sustained therapy of LHRHA or bilateral orchiectomy;
  6. Adequate hepatic, renal, heart, and hematological functions;
  7. 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performance of any study-related procedure not part of normal medical care,with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care;
  8. Expected to survive for at least 3 months;
  9. Patient has been treated with Abiraterone and treatment failed;Treatment failure is defined as the progression of disease during treatment;

Exclusion Criteria:

  1. Have received any anti-tumor therapy in the past 4 weeks,including radiotherapy, chemotherapy, operation, targeted therapy, immuntherapy, and endocrinotherapy;
  2. 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;
  3. Plan to receive any other anti-tumor treatment during this trial;
  4. Subjects have contraindications to prednisone, such as active infections or other conditions;
  5. Subjects present any chronic condition requiring treatment with corticosteroids at doses greater than prednisone 5 mg, BID;
  6. 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;
  7. 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;
  8. 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;
  9. Imaging diagnosis of brain tumor lesions;
  10. history of pituitary or adrenal dysfunction;
  11. 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);
  12. 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;
  13. History of immunodeficiency (including HIV positive, other acquired, congenital immunodeficiency disease) or organ transplant history;
  14. Habitual constipation or diarrhea, irritable bowel syndrome, inflammatory bowel disease; abdominal fistula, gastrointestinal perforation or abdominal abscess within 6 months before the first dose;
  15. Patients who are unwilling to take effective contraceptive measures during the entire study period and within 3 months after the last dose

View trial on ClinicalTrials.gov


email news signup