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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.

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.


Condition or disease Intervention/treatment Phase
Prostate Cancer Metastatic Castration-resistant Prostate Cancer Drug: HC-1119 Drug: Enzalutamide Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 430 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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)
Estimated Study Start Date : May 2019
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: HC-1119
Oral dose of 80 mg/day
Drug: Enzalutamide
oral once daily 160 mg

Active Comparator: enzalutamide
Oral dose of 160 mg/day
Drug: HC-1119
oral once daily 80 mg




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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)

  3. Overall Survival (OS) [ Time Frame: Week 24 ]
    To determine the efficacy of HC-1119 as compared to enzalutamide as assessed by overall survival (OS)

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03850795


Contacts
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Contact: Frank Perabo, MD (713) 963-3670 fperabo@hinovapharma.com

Sponsors and Collaborators
Hinova Pharmaceuticals USA, Inc.

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Responsible Party: Hinova Pharmaceuticals USA, Inc.
ClinicalTrials.gov Identifier: NCT03850795     History of Changes
Other Study ID Numbers: HC1119-CS-03
First Posted: February 22, 2019    Key Record Dates
Last Update Posted: February 22, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hinova Pharmaceuticals USA, Inc.:
HC-1119
enzalutamide
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases