Metastatic Castration Resistant Prostate Cancer Clinical Trial
Official title:
A Clinical Study for Evaluating Enzalutamide Pharmacokinetics and Pharmacodynamics, and Related Changes After Drug Switch in Chinese Patients With Metastatic Castration-Resistant Prostate Cancer
Verified date | October 2020 |
Source | Hinova Pharmaceuticals Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a study for evaluating enzalutamide pharmacokinetics and pharmacodynamics, and related changes after drug switch in Chinese patients with metastatic castration-resistant prostate cancer. The study primary objective is to evaluate the pharmacokinetic characteristics of enzalutamide in Chinese patients with mCRPC.
Status | Completed |
Enrollment | 10 |
Est. completion date | August 28, 2019 |
Est. primary completion date | October 24, 2018 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 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. Exclusion Criteria: 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; 4. Uncontrolled hypertension (systolic = 160 mmHg or diastolic = 100 mmHg) or other serious cardiovascular diseases. (Patients with a history of hypertension is eligible if his blood pressure is controlled with antihypertensives); 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 5a-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. |
Country | Name | City | State |
---|---|---|---|
China | Medical Ethics Committee of Hunan Cancer Hospital | Changsha |
Lead Sponsor | Collaborator |
---|---|
Hinova Pharmaceuticals Inc. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximum drug concentration(Cmax) | From the first dose of the study drug to 12 weeks after dose | ||
Primary | Time of maximum drug concentration(Tmax) | From the first dose of the study drug to 12 weeks after dose | ||
Primary | Area under curve from time 0 to 24h (AUC0-24h) | From the first dose of the study drug to 12 weeks after dose | ||
Secondary | Maximum drug concentration(Cmax) | From 13 weeks to 24 weeks after dose | ||
Secondary | Time of maximum drug concentration(Tmax) | From 13 weeks to 24 weeks after dose | ||
Secondary | Area under curve from time 0 to 24h (AUC0-24h) | From 13 weeks to 24 weeks after dose | ||
Secondary | Number of patients with adverse events | Safety measures | From the first dose of the study drug to 24 weeks after dose | |
Secondary | Percentage of patients with > 50% decrease in prostate specific antigen (PSA) | Percentage of patients with > 50% decrease in PSA levels from baseline at weeks1,3,5 6, 8, 10, and 12. | From the first dose of the study drug to 12 weeks after dose |
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