Metastatic Castration Resistant Prostate Cancer Clinical Trial
Official title:
A Phase I Study Evaluating Tolerability, Pharmacokinetics, and Preliminary Efficacy of HC-1119 in 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 phase I study evaluating tolerability, pharmacokinetics, and preliminary efficacy of HC-1119 in patients with metastatic castration-resistant prostate cancer. The study objective is to study the tolerability, safety, and dose-limiting toxicities (DLT) of HC-1119 in patients with mCRPC.
Status | Completed |
Enrollment | 43 |
Est. completion date | August 28, 2019 |
Est. primary completion date | September 26, 2018 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria (those who meet all of the following are eligible): 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. Exclusion Criteria (those who meet any one of the following are ineligible): 1. Ongoing toxicity ( = Grade 2 toxicity) from previous treatments; 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; 14. Uncontrolled hypertension (systolic = 160 mmHg or diastolic = 100 mmHg). Patients with a history of hypertension is eligible if his blood pressure is controlled with antihypertensives; 15. Medications that lower the seizure threshold must be used during the study; 16. Treatment with 5a-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. |
Country | Name | City | State |
---|---|---|---|
China | Hinova Pharmaceuticals Inc. | Chengdu | Sichuan |
Lead Sponsor | Collaborator |
---|---|
Hinova Pharmaceuticals Inc. | West China Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Dose-limiting toxicities(DLT) | Safety measures | From the first dose of the study to the 12th week after dose | |
Primary | Number of patients with adverse events | Safety measures | From the first dose of the study to the 12th week after dose | |
Secondary | Maximum drug concentration(Cmax) | Single-dose and repeated-dose | From the first dose of the study to the 12th week after dose | |
Secondary | Time of maximum drug concentration(Tmax) | Single-dose and repeated-dose | From the first dose of the study to the 12th week after dose | |
Secondary | Area under curve from time 0 to 24h (AUC0-24h) | Single-dose and repeated-dose | From the first dose of the study to the 12th week after dose | |
Secondary | Maximal PSA Response Rate | Percentage of patients with > 50% decrease in PSA levels from baseline during the 12-week treatment period | From the first dose of the study to the 12th week after dose | |
Secondary | Response rate of prostate specific antigen (PSA) | Percentage of patients with > 50% decrease in PSA levels from baseline at weeks 6, 8, 10, and 12. | From the first dose of the study to the 12th week after dose |
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