Clinical Trials /

HC-1119 Versus Enzalutamide in Metastatic Castration-Resistant Prostate Cancer (mCRPC)

NCT03850795

Description:

This study is a multinational Phase 3, randomized, double-blind, non-inferiority, efficacy and safety study of oral HC-1119 (80 mg/day) versus enzalutamide (160 mg/day) in asymptomatic or mildly symptomatic patients with progressive metastatic castration-resistant prostate cancer (mCRPC). The following assessment of prostate cancer status will be collected during the course of the trial: soft tissue disease on computed tomography (CT) scan or on magnetic resonance imaging (MRI), bone disease on radionuclide bone scans, FACT-P and EQ-5D, Brief Fatigue Inventory, and PSA. Throughout the study, safety and tolerability will be assessed by the recording of adverse events, monitoring of vital signs and physical examinations, safety laboratory evaluations, and 12-lead electrocardiograms (ECGs). Blood samples for population pharmacokinetics for HC-1119 and enzalutamide and related metabolites will be collected.

Related Conditions:
  • Prostate Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: HC-1119 Versus Enzalutamide in Metastatic Castration-Resistant Prostate Cancer (mCRPC)
  • Official Title: PROCADE: A Multinational Phase 3, Randomized, Double-Blind, Non-inferiority, Efficacy and Safety Study of Oral HC-1119 Versus Enzalutamide in Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Clinical Trial IDs

  • ORG STUDY ID: HC1119-CS-03
  • NCT ID: NCT03850795

Conditions

  • Prostate Cancer Metastatic
  • Castration-resistant Prostate Cancer

Interventions

DrugSynonymsArms
HC-1119enzalutamide
EnzalutamideHC-1119

Purpose

This study is a multinational Phase 3, randomized, double-blind, non-inferiority, efficacy and safety study of oral HC-1119 (80 mg/day) versus enzalutamide (160 mg/day) in asymptomatic or mildly symptomatic patients with progressive metastatic castration-resistant prostate cancer (mCRPC). The following assessment of prostate cancer status will be collected during the course of the trial: soft tissue disease on computed tomography (CT) scan or on magnetic resonance imaging (MRI), bone disease on radionuclide bone scans, FACT-P and EQ-5D, Brief Fatigue Inventory, and PSA. Throughout the study, safety and tolerability will be assessed by the recording of adverse events, monitoring of vital signs and physical examinations, safety laboratory evaluations, and 12-lead electrocardiograms (ECGs). Blood samples for population pharmacokinetics for HC-1119 and enzalutamide and related metabolites will be collected.

Detailed Description

      This study is a multinational Phase 3, randomized, double-blind, non-inferiority, efficacy
      and safety study of oral HC-1119 (80 mg/day) versus enzalutamide (160 mg/day) in asymptomatic
      or mildly symptomatic patients with progressive metastatic castration-resistant prostate
      cancer (mCRPC). Patients must not have been previously treated with next generation
      AR-Inhibitors or Androgen-biosynthesis Inhibitors, or prior progression on ketoconazole.

      The following assessments of prostate cancer status will be collected during the course of
      the trial: soft tissue disease on computed tomography (CT) scan or on magnetic resonance
      imaging (MRI), bone disease on radionuclide bone scans, FACT-P and EQ-5D, Brief Fatigue
      Inventory, and PSA. Radiographic disease progression is defined by the Response Evaluation
      Criteria in Solid Tumors, version 1.1 (RECIST 1.1) for soft tissue disease, or the appearance
      of two or more new bone lesions on bone scan.

      Throughout the study, safety and tolerability will be assessed by the recording of adverse
      events, monitoring of vital signs and physical examinations, safety laboratory evaluations,
      and 12-lead electrocardiograms (ECGs). Blood samples for population pharmacokinetics for
      HC-1119 and enzalutamide and related metabolites will be collected pre-dose on Day 1 and
      prior to dosing on Days 8 (Week 2), 15 (Week 3) and 22 (Week 4), 29 (Week 5), 57 (Week 9), 85
      (Week 13) and Day 169 (Week 25). Blood samples for calculating a 24 hour pharmacokinetic
      profile of HC-1119 and enzalutamide and related metabolites will be collected in a subset of
      24 Caucasian (non-Chinese) patients on Day 1 and at steady state in week 9.

      Patients will have a safety follow-up visit 30 days after their last dose of study drug or
      prior to initiation of any new therapy, or an investigational agent, whichever occurs first.
    

Trial Arms

NameTypeDescriptionInterventions
HC-1119ExperimentalOral dose of 80 mg/day
  • Enzalutamide
enzalutamideActive ComparatorOral dose of 160 mg/day
  • HC-1119

Eligibility Criteria

        Inclusion Criteria:

        Subjects must meet the following inclusion criteria:

          -  Ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH)
             analogue, antagonist, or bilateral orchiectomy (i.e., surgical or medical castration);

          -  Serum testosterone level < 1.7 nmol/L (50 ng/dL) at the Screening visit;

          -  Progressive disease at study entry defined as one or more of the following three
             criteria that occurred while the patient was on androgen deprivation;

          -  No prior cytotoxic chemotherapy

          -  Asymptomatic or mildly symptomatic from prostate cancer;

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 as judged by the
             Investigators' clinical assessment;

          -  Estimated life expectancy of ≥ 6 months;

        Exclusion Criteria:

        Subjects must NOT meet any of the following exclusion criteria:

          -  Severe concurrent disease, infection, or co-morbidity that, in the judgment of the
             investigator, would make the patient inappropriate for enrollment;

          -  Known or suspected brain metastasis or active leptomeningeal disease;

          -  Regular daily use of opiate analgesics for pain from prostate cancer within four weeks
             of enrollment (Day 1 visit);

          -  Absolute neutrophil count < 1,500/µL, platelet count < 100,000/µL, and hemoglobin <
             5.6 mmol/L (9 g/dL) at the Screening visit;

          -  Total bilirubin, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >
             2.5 times the upper limit of normal at the Screening visit;

          -  Creatinine > 177 µmol/L (2 mg/dL) at the Screening visit;

          -  Albumin < 30 g/L (3.0 g/dL) at the Screening visit;

          -  Prior use, or participation in a clinical trial, of an investigational agent that
             blocks androgen synthesis (e.g., abiraterone, galeterone, seviteronel) or blocks the
             androgen receptor (e.g., apalutamide, duralutamide, enzalutamide, proxalutamide);

          -  Participation in a previous clinical trial of HC-1119;

          -  Radiation therapy for treatment of the primary tumor within three weeks of enrollment

          -  Radionuclide therapy for treatment of metastasis;
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Male
Healthy Volunteers:No

Primary Outcome Measures

Measure:Overall Response Rate (ORR)
Time Frame:Week 24
Safety Issue:
Description:To determine the efficacy of HC-1119 as compared to enzalutamide as assessed by overall response rate (ORR) by RECIST 1.1.

Secondary Outcome Measures

Measure:PSA decline of ≥50% from baseline
Time Frame:Week 24
Safety Issue:
Description:To determine the efficacy of HC-1119 as compared to enzalutamide as assessed by decline of ≥50% from baseline
Measure:Radiographic Progression-free Survival (rPFS)
Time Frame:Week 24
Safety Issue:
Description:To determine the efficacy of HC-1119 as compared to enzalutamide as assessed by radiographic progression-free survival (rPFS)
Measure:Overall Survival (OS)
Time Frame:Week 24
Safety Issue:
Description:To determine the efficacy of HC-1119 as compared to enzalutamide as assessed by overall survival (OS)
Measure:Safety and Tolerability (based on Common Terminology Criteria for Adverse Events (CTCAE), version 5.0)
Time Frame:Week 24
Safety Issue:
Description:To determine the safety and tolerability of orally administrated HC-1119 as compared to enzalutamide based on Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Hinova Pharmaceuticals USA, Inc.

Trial Keywords

  • HC-1119
  • enzalutamide

Last Updated

November 20, 2020