Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hinova Pharmaceuticals Inc.
With
West China Hospital
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
1. Voluntarily participated in the study, with understanding of relevant study procedures and signed informed consent form;
2. Male , ≥18 years old;
3. With histologically or cytologically confirmed prostate cancer, without neuroendocrine carcinoma or ductal adenocarcinoma;
4. With evidence of metastatic disease (such as bone scan and CT/MRI results);
5. Patients with relapsed, refractory, or progressive disease despite castration (surgery or chemical) or combined androgen deprivation therapy (Progressive disease is defined as 1 or more of the following 3 criteria: Serum PSA progression: A minimum of 3 rising PSA values with an interval of at least 1 week between determinations, resulting in a final value higher than 50% of the minimum, with a starting PSA value \> 2 ng/ml; Soft tissue disease progression as defined by RECIST 1.1; Bone disease progression defined by PCWG2 with 2 or more new metastatic lesions on bone scan);
6. Castrate levels of testosterone (\< 50 ng/dl) at screening;
7. Bilateral orchiectomy or ongoing androgen deprivation therapy with effective GnRH analogues;
8. Estimated life expectancy \> 6 months;
9. ECOG performance status ≤ 1;
10. Laboratory tests must meet the following criteria:
1. Routine Blood Test: hemoglobin (Hb) ≥ 90 g/L (no blood transfusion within the last 14 days); absolute neutrophil count (ANC) ≥ 1.5 x 109/L; platelet count (PLT) ≥ 80 x 109/L;
2. Blood Biochemistry: creatinine (Cr) ≤ 2 x upper limit of normal (ULN), or Cr \> 2 x ULN but the calculated CrCl ≥ 60 mL/min; bilirubin (BIL) ≤ 2 x ULN; alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤ 2.5 x ULN (or ≤ 5.0 x ULN for patients with liver metastases);
3. Coagulation: INR \< 1.5.
15. Medications that lower the seizure threshold must be used during the study;
16. Treatment with 5α-reductase inhibitors (finasteride, dutasteride), estrogen, or cyproterone within the past 4 weeks;
17. Treatment with ketoconazole within the past 4 weeks;
18. Previously treated with investigational or approved medications that inhibit testosterone synthesis (such as abiraterone acetate, TAK-683, and TAK-448) or target testosterone receptors (such as enzalutamide, SHR3680, proxalutamide, and ARN509);
19. Participated in other clinical trials within 1 month prior to enrollment;
20. Subjects is determined by the investigator to be unsuitable for this study.
2. Clinically significant GI dysfunction which may affect the intake, transport, or absorption of drug (such as inability to swallow, chronic diarrhea, and bowel obstruction, etc.), or patients with complete gastrectomy;
3. History of allergies, or known hypersensitivity to components of the investigational drug;
4. Brain metastases;
5. Other malignancies within the last 5 years (except for curatively treated non-melanoma skin cancer);
6. History of organ transplants
7. HIV seropositive;
8. Past medical history of seizures or serious CNS diseases;
9. History of unexplained coma;
10. Family history of seizures;
11. History of traumatic brain injury;
12. History of medication or drug abuse;
13. Patients with severe cardiovascular diseases, including those with myocardial infarction, arterial thrombosis, unstable angina, or clinical symptomatic heart failure within the past 6 months;
