A Clinical Study for Evaluating Enzalutamide Pharmacokinetics and Pharmacodynamics, and Related Changes After Drug Switch in Chinese Patients With Metastatic Castration-Resistant Prostate Cancer

Hinova Pharmaceuticals Inc.1 site in 1 country10 target enrollmentFebruary 7, 2018

ConditionsMetastatic Castration Resistant Prostate Cancer

InterventionsEnzalutamide HC1119

DrugsEnzalutamide HC1119

Overview

Phase: Phase 1
Intervention: Enzalutamide
Conditions: Metastatic Castration Resistant Prostate Cancer
Sponsor: Hinova Pharmaceuticals Inc.
Enrollment: 10
Locations: 1
Primary Endpoint: Maximum drug concentration(Cmax)
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

February 7, 2018

End Date

August 28, 2019

Last Updated

5 years ago

Study Type

Interventional

Study Design

Sequential

Sex

Male

Investigators

Sponsor

Hinova Pharmaceuticals Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Voluntarily participated in the study, with understanding of and will to comply with relevant study procedures and signed informed consent form;
•Chinese male, ≥ 18 years old;
•With histologically or cytologically confirmed prostate cancer, without neuroendocrine carcinoma or ductal adenocarcinoma;
•With evidence of metastatic lesions (such as bone scan and CT/MRI);
•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);
•Castrate levels of testosterone (\< 50 ng/dl) at screening; bilateral orchiectomy or ongoing androgen deprivation therapy with effective GnRH analogues;
•ECOG performance status ≤1;
•Laboratory tests must meet the following criteria:
•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;
•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);

Exclusion Criteria

•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;
•Brain metastases;
•Subjects are excluded if any of the following conditions are met:
•Other malignancies within the last 5 years (except for curatively treated non-melanoma skin cancer);
•History of organ transplants;
•Past medical history of seizures, serious CNS diseases, or unexplained coma, family history of seizures, or history of traumatic brain injury;
•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);
•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;
•Other uncontrolled clinical diseases, including but not limited to: persistent or active infections.
•Subjects are excluded if any of the following conditions regarding past or concomitant medication are met:

Arms & Interventions

enzalutamide

160mg

Intervention: Enzalutamide

HC-1119

To be determined

Intervention: HC1119

Outcomes

Primary Outcomes

Maximum drug concentration(Cmax)

Time Frame: From the first dose of the study drug to 12 weeks after dose

Area under curve from time 0 to 24h (AUC0-24h)

Time Frame: From the first dose of the study drug to 12 weeks after dose

Time of maximum drug concentration(Tmax)

Time Frame: From the first dose of the study drug to 12 weeks after dose

Secondary Outcomes

Maximum drug concentration(Cmax)(From 13 weeks to 24 weeks after dose)
Time of maximum drug concentration(Tmax)(From 13 weeks to 24 weeks after dose)
Number of patients with adverse events(From the first dose of the study drug to 24 weeks after dose)
Area under curve from time 0 to 24h (AUC0-24h)(From 13 weeks to 24 weeks after dose)
Percentage of patients with > 50% decrease in prostate specific antigen (PSA)(From the first dose of the study drug to 12 weeks after dose)