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

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ClinicalTrials.gov Identifier: NCT03850795
Recruitment Status : Not yet recruiting
First Posted : February 22, 2019
Last Update Posted : February 22, 2019
Sponsor:
Information provided by (Responsible Party):
Hinova Pharmaceuticals USA, Inc.

Tracking Information
First Submitted Date  ICMJE February 20, 2019
First Posted Date  ICMJE February 22, 2019
Last Update Posted Date February 22, 2019
Estimated Study Start Date  ICMJE May 2019
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 21, 2019)
Overall Response Rate (ORR) [ Time Frame: Week 24 ]
To determine the efficacy of HC-1119 as compared to enzalutamide as assessed by overall response rate (ORR) by RECIST 1.1.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 21, 2019)
  • PSA decline of ≥50% from baseline [ Time Frame: Week 24 ]
    To determine the efficacy of HC-1119 as compared to enzalutamide as assessed by decline of ≥50% from baseline
  • Radiographic Progression-free Survival (rPFS) [ Time Frame: Week 24 ]
    To determine the efficacy of HC-1119 as compared to enzalutamide as assessed by radiographic progression-free survival (rPFS)
  • Overall Survival (OS) [ Time Frame: Week 24 ]
    To determine the efficacy of HC-1119 as compared to enzalutamide as assessed by overall survival (OS)
  • Safety and Tolerability (based on Common Terminology Criteria for Adverse Events (CTCAE), version 5.0) [ Time Frame: Week 24 ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE HC-1119 Versus Enzalutamide in Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Official Title  ICMJE 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)
Brief Summary

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Prostate Cancer Metastatic
  • Castration-resistant Prostate Cancer
Intervention  ICMJE
  • Drug: HC-1119
    oral once daily 80 mg
  • Drug: Enzalutamide
    oral once daily 160 mg
Study Arms  ICMJE
  • Experimental: HC-1119
    Oral dose of 80 mg/day
    Intervention: Drug: Enzalutamide
  • Active Comparator: enzalutamide
    Oral dose of 160 mg/day
    Intervention: Drug: HC-1119
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: February 21, 2019)
430
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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;
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Frank Perabo, MD (713) 963-3670 fperabo@hinovapharma.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03850795
Other Study ID Numbers  ICMJE HC1119-CS-03
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Hinova Pharmaceuticals USA, Inc.
Study Sponsor  ICMJE Hinova Pharmaceuticals USA, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Hinova Pharmaceuticals USA, Inc.
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP