Status:
COMPLETED
A Study Evaluating Tolerability, Pharmacokinetics, and Preliminary Efficacy of HC-1119 in Patients.
Lead Sponsor:
Hinova Pharmaceuticals Inc.
Collaborating Sponsors:
West China Hospital
Conditions:
Metastatic Castration Resistant Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE1
Brief Summary
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...
Eligibility Criteria
Inclusion
- Inclusion Criteria (those who meet all of the following are eligible):
- Voluntarily participated in the study, with understanding of relevant study procedures and signed informed consent form;
- Male , ≥18 years old;
- With histologically or cytologically confirmed prostate cancer, without neuroendocrine carcinoma or ductal adenocarcinoma;
- With evidence of metastatic disease (such as bone scan and CT/MRI results);
- 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);
- Castrate levels of testosterone (\< 50 ng/dl) at screening;
- Bilateral orchiectomy or ongoing androgen deprivation therapy with effective GnRH analogues;
- Estimated life expectancy \> 6 months;
- ECOG performance status ≤ 1;
- Laboratory tests must meet the following criteria:
- 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;
- 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);
- Coagulation: INR \< 1.5.
- Exclusion Criteria (those who meet any one of the following are ineligible):
- Ongoing toxicity ( ≥ Grade 2 toxicity) from previous treatments;
- 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;
- History of allergies, or known hypersensitivity to components of the investigational drug;
- Brain metastases;
- Other malignancies within the last 5 years (except for curatively treated non-melanoma skin cancer);
- History of organ transplants
- HIV seropositive;
- Past medical history of seizures or serious CNS diseases;
- History of unexplained coma;
- Family history of seizures;
- History of traumatic brain injury;
- History of medication or drug abuse;
- Patients with severe cardiovascular diseases, including those with myocardial infarction, arterial thrombosis, unstable angina, or clinical symptomatic heart failure within the past 6 months;
- 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;
- Medications that lower the seizure threshold must be used during the study;
- Treatment with 5α-reductase inhibitors (finasteride, dutasteride), estrogen, or cyproterone within the past 4 weeks;
- Treatment with ketoconazole within the past 4 weeks;
- 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);
- Participated in other clinical trials within 1 month prior to enrollment;
- Subjects is determined by the investigator to be unsuitable for this study.
Exclusion
Key Trial Info
Start Date :
February 10 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 28 2019
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT03774056
Start Date
February 10 2017
End Date
August 28 2019
Last Update
November 3 2020
Active Locations (1)
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1
Hinova Pharmaceuticals Inc.
Chengdu, Sichuan, China, 610041