Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hinova Pharmaceuticals Inc.
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
1. Voluntarily participated in the study, with understanding of and will to comply with relevant study procedures and signed informed consent form;
2. Chinese male, ≥ 18 years old;
3. With histologically or cytologically confirmed prostate cancer, without neuroendocrine carcinoma or ductal adenocarcinoma;
4. With evidence of metastatic lesions (such as bone scan and CT/MRI);
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: 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 progression as defined by PCWG2 with 2 or more new lesions on bone scan);
6. Castrate levels of testosterone (\< 50 ng/dl) at screening; bilateral orchiectomy or ongoing androgen deprivation therapy with effective GnRH analogues;
7. ECOG performance status ≤1;
8. Laboratory tests must meet the following criteria:
1. Routine Blood Test: hemoglobin (Hb) ≥ 90g/L (no blood transfusions within 14 days prior to screening); 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.
9. Estimated life expectancy \> 6 months.
5. 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;
6. Other uncontrolled clinical diseases, including but not limited to: persistent or active infections.
4. Subjects are excluded if any of the following conditions regarding past or concomitant medication are met:
1. Medications that lower the seizure threshold must be used during the trial;
2. Treatment with 5α-reductase inhibitors (finasteride, dutasteride), estrogen, or cyproterone within 4 weeks prior to screening;
3. Treatment with ketoconazole within 4 weeks prior to screening;
4. 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 SHR3680, proxalutamide, and ARN509), except for bicalutamide and flutamide.
5. Known hypersensitivity to any ingredient of the study drugs (enzalutamide and HC-1119) or similar drugs;
6. HIV seropositive;
7. History of medication or drug abuse;
8. Other conditions that subject is determined by the investigator to be unsuitable for this study.
You may not be if
1. Participated in other clinical drug trials within 1 month prior to screening, or the occurrence of toxicity caused by previous treatments that has not been relieved to ≤ Grade 2 toxicity (according to CTCAE 4.03) prior to enrollment;
2. Brain metastases;
3. Subjects are excluded if any of the following conditions are met:
1. Other malignancies within the last 5 years (except for curatively treated non-melanoma skin cancer);
2. History of organ transplants;
3. Past medical history of seizures, serious CNS diseases, or unexplained coma, family history of seizures, or history of traumatic brain injury;
