HC-1119 Versus Enzalutamide in Metastatic Castration-Resistant Prostate Cancer (mCRPC)
NCT ID: NCT03850795
Last Updated: 2024-08-19
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
TERMINATED
Clinical Phase
PHASE3
Total Enrollment
104 participants
Study Classification
INTERVENTIONAL
Study Start Date
2021-03-15
Study Completion Date
2024-06-28
Brief Summary
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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.
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.
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Detailed Description
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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.
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.
Conditions
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Prostate Cancer Metastatic
Castration-resistant Prostate Cancer
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Participants
Investigators
Study Groups
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HC-1119
Oral dose of 80 mg/day
Group Type
EXPERIMENTAL
HC-1119
Intervention Type
DRUG
oral once daily 80 mg
enzalutamide
Oral dose of 160 mg/day
Group Type
ACTIVE_COMPARATOR
Enzalutamide
Intervention Type
DRUG
oral once daily 160 mg
Interventions
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HC-1119
oral once daily 80 mg
Intervention Type
DRUG
Enzalutamide
oral once daily 160 mg
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
1. Age 18 or older and willing and able to give informed consent.
2. Histologically or cytologically confirmed adenocarcinoma of the prostate without significant and relevant neuroendocrine differentiation or small cell features, per investigator's judgment.
3. Ongoing ADT with a GnRH analogue, antagonist or bilateral orchiectomy (i.e., surgical or medical castration).
4. For patients who have not had a bilateral orchiectomy, there must be a plan to maintain effective GnRH analogue or antagonist therapy for the duration of the trial.
5. Serum testosterone level \< 1.7 nmol/L (50 ng/dL) at the Screening visit.
6. Patients receiving bisphosphonate or denosumab therapy must have been on stable doses for at least four weeks (from Day 1 visit).
7. Progressive disease at study entry defined as one or more of the following three criteria that occurred while the patient was on ADT as defined in eligibility criterion #3:
1. PSA progression defined by a minimum of two rising PSA levels with an interval of ≥ 1 week between each determination. Patients who received an anti-androgen agent must have progression after withdrawal (≥ 4 weeks since last flutamide or ≥ 6 weeks since last bicalutamide or nilutamide). The PSA value at the Screening visit should be ≥ 2 µg/L (2 ng/mL)
2. Soft tissue disease progression defined by RECIST 1.1
3. Bone disease progression defined by PCWG3 with two or more new lesions on bone scan
8. Metastatic disease documented by measurable soft tissue disease by CT/MRI per RECIST 1.1 criteria. Patients are allowed to have any metastatic disease (i.e. bone metastasis) as long as they also have measurable soft tissue lesions per RECIST 1.1..
9. No prior cytotoxic chemotherapy for prostate cancer.
10. Asymptomatic or mildly symptomatic from prostate cancer.
11. ECOG performance status of 0-1 per the Investigators' clinical assessment
12. Estimated life expectancy of ≥ 6 months
13. Able to swallow the study drug and comply with study requirements
14. All sexually active patients are required to use a condom as well as meet 1 of the following:
1. Patient is non-fertile (orchiectomy) or has a female partner of non-childbearing potential (i.e., post-menopausal, surgically sterilized, hysterectomy)
2. Patient and his female partner must agree to use an adequate contraceptive method from the first day of dosing until 3 months after the last dose to prevent pregnancies. Adequate contraceptive method is defined as:
i. Established use of oral, injected, or implanted hormonal methods of contraception.
ii. Placement of an intra-uterine device or intra-uterine system. iii. Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.
iv. Tubal ligation for at least 6 months prior to screening.
15. Male patient engaged in sexual activity with a pregnant female is required to use a condom from the first day of dosing until 3 months after the last dose of treatment with study drugs.
2. Histologically or cytologically confirmed adenocarcinoma of the prostate without significant and relevant neuroendocrine differentiation or small cell features, per investigator's judgment.
3. Ongoing ADT with a GnRH analogue, antagonist or bilateral orchiectomy (i.e., surgical or medical castration).
4. For patients who have not had a bilateral orchiectomy, there must be a plan to maintain effective GnRH analogue or antagonist therapy for the duration of the trial.
5. Serum testosterone level \< 1.7 nmol/L (50 ng/dL) at the Screening visit.
6. Patients receiving bisphosphonate or denosumab therapy must have been on stable doses for at least four weeks (from Day 1 visit).
7. Progressive disease at study entry defined as one or more of the following three criteria that occurred while the patient was on ADT as defined in eligibility criterion #3:
1. PSA progression defined by a minimum of two rising PSA levels with an interval of ≥ 1 week between each determination. Patients who received an anti-androgen agent must have progression after withdrawal (≥ 4 weeks since last flutamide or ≥ 6 weeks since last bicalutamide or nilutamide). The PSA value at the Screening visit should be ≥ 2 µg/L (2 ng/mL)
2. Soft tissue disease progression defined by RECIST 1.1
3. Bone disease progression defined by PCWG3 with two or more new lesions on bone scan
8. Metastatic disease documented by measurable soft tissue disease by CT/MRI per RECIST 1.1 criteria. Patients are allowed to have any metastatic disease (i.e. bone metastasis) as long as they also have measurable soft tissue lesions per RECIST 1.1..
9. No prior cytotoxic chemotherapy for prostate cancer.
10. Asymptomatic or mildly symptomatic from prostate cancer.
11. ECOG performance status of 0-1 per the Investigators' clinical assessment
12. Estimated life expectancy of ≥ 6 months
13. Able to swallow the study drug and comply with study requirements
14. All sexually active patients are required to use a condom as well as meet 1 of the following:
1. Patient is non-fertile (orchiectomy) or has a female partner of non-childbearing potential (i.e., post-menopausal, surgically sterilized, hysterectomy)
2. Patient and his female partner must agree to use an adequate contraceptive method from the first day of dosing until 3 months after the last dose to prevent pregnancies. Adequate contraceptive method is defined as:
i. Established use of oral, injected, or implanted hormonal methods of contraception.
ii. Placement of an intra-uterine device or intra-uterine system. iii. Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.
iv. Tubal ligation for at least 6 months prior to screening.
15. Male patient engaged in sexual activity with a pregnant female is required to use a condom from the first day of dosing until 3 months after the last dose of treatment with study drugs.
Exclusion Criteria
1. Severe concurrent disease, infection, or co-morbidity that, in the judgment of the investigator, would make the patient inappropriate for enrollment.
2. Known or suspected brain metastasis or active leptomeningeal disease.
3. Regular daily use of opiate analgesics for pain from prostate cancer within four weeks of enrollment (Day 1 visit).
4. WBC count \< 3,000/µL, or absolute neutrophil count \< 1,500/µL, or platelet count \< 100,000/µL, or hemoglobin \< 5.6 mmol/L (9 g/dL) at the Screening visit (NOTE: patients may not have received any growth factors or blood transfusions or any therapeutic invention within 14 days of the hematologic laboratory values obtained at the Screening visit).
5. Total bilirubin, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2.5 times the upper limit of normal at the Screening visit; no therapeutic invention within 14 days before screening.
6. Creatinine clearance \< 30 mL/min as calculated using the Cockcroft-Gault equation at the Screening visit. Creatinine Clearance (mL/min) = \[\[140-Age (years)\] \* Weight (kg)\] / \[72 \* Serum Creatinine (mg/dL)\]
7. Albumin \< 30 g/L (3.0 g/dL) at the Screening visit, no therapeutic invention within 14 days before screening.
8. History of another malignancy within the previous two years other than curatively treated non-melanomatous skin cancer.
9. Treatment with flutamide within four weeks of enrollment (Day 1 visit).
10. Treatment with bicalutamide or nilutamide within six weeks of enrollment (Day 1 visit).
11. Treatment with 5-α reductase inhibitors (finasteride, dutasteride), estrogens within four weeks of enrollment (Day 1 visit).
12. Treatment with systemic biologic therapy for prostate cancer (other than approved bone targeted agents) within four weeks of enrollment (Day 1 visit).
13. Use of herbal products that may have hormonal anti-prostate cancer activity and/or are known to decrease PSA levels (e.g., saw palmetto) or systemic corticosteroids greater than the equivalent of 10 mg of prednisone/prednisolone per day within four weeks of enrollment (Day 1 visit).
14. Prior use, or participation in a clinical trial, of an agent that blocks androgen synthesis (e.g., abiraterone) or blocks the AR (e.g., apalutamide, darolutamide, enzalutamide, proxalutamide).
15. Participation in a previous clinical trial of HC-1119.
16. Use of an investigational agent within four weeks of enrollment (Day 1 visit).
17. Radiation therapy for treatment of the primary tumor within three weeks of enrollment (Day 1 visit).
18. Radionuclide therapy (Radium 223) for treatment of metastasis within four weeks of enrollment (Day 1 visit).
19. Clinically significant cardiovascular disease or condition
20. Treatment with strong CYP2C8 inhibitors and inducers, CYP3A4 inducers, medications which are known to prolong the QT interval (see Appendix C).
21. History of seizure or any condition that may predispose to seizure.
22. Conditions that predispose subjects to increased risk for falls or fractures according to the discretion of the Investigator.
23. Gastrointestinal disorder affecting absorption (e.g., gastrectomy, active peptic ulcer disease within last three months).
24. Major surgery within four weeks prior to enrollment (Day 1 visit).
25. Have active infection with HBV measured by hepatitis B surface antigen (HBsAg) test, HCV measured by RNA test and HIV measured by antibody test.
26. Have known active tuberculosis.
27. Known hypersensitivity to HC-1119, enzalutamide, or any of the excipients.
28. Rare hereditary problems of fructose intolerance due to sorbitol
2. Known or suspected brain metastasis or active leptomeningeal disease.
3. Regular daily use of opiate analgesics for pain from prostate cancer within four weeks of enrollment (Day 1 visit).
4. WBC count \< 3,000/µL, or absolute neutrophil count \< 1,500/µL, or platelet count \< 100,000/µL, or hemoglobin \< 5.6 mmol/L (9 g/dL) at the Screening visit (NOTE: patients may not have received any growth factors or blood transfusions or any therapeutic invention within 14 days of the hematologic laboratory values obtained at the Screening visit).
5. Total bilirubin, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2.5 times the upper limit of normal at the Screening visit; no therapeutic invention within 14 days before screening.
6. Creatinine clearance \< 30 mL/min as calculated using the Cockcroft-Gault equation at the Screening visit. Creatinine Clearance (mL/min) = \[\[140-Age (years)\] \* Weight (kg)\] / \[72 \* Serum Creatinine (mg/dL)\]
7. Albumin \< 30 g/L (3.0 g/dL) at the Screening visit, no therapeutic invention within 14 days before screening.
8. History of another malignancy within the previous two years other than curatively treated non-melanomatous skin cancer.
9. Treatment with flutamide within four weeks of enrollment (Day 1 visit).
10. Treatment with bicalutamide or nilutamide within six weeks of enrollment (Day 1 visit).
11. Treatment with 5-α reductase inhibitors (finasteride, dutasteride), estrogens within four weeks of enrollment (Day 1 visit).
12. Treatment with systemic biologic therapy for prostate cancer (other than approved bone targeted agents) within four weeks of enrollment (Day 1 visit).
13. Use of herbal products that may have hormonal anti-prostate cancer activity and/or are known to decrease PSA levels (e.g., saw palmetto) or systemic corticosteroids greater than the equivalent of 10 mg of prednisone/prednisolone per day within four weeks of enrollment (Day 1 visit).
14. Prior use, or participation in a clinical trial, of an agent that blocks androgen synthesis (e.g., abiraterone) or blocks the AR (e.g., apalutamide, darolutamide, enzalutamide, proxalutamide).
15. Participation in a previous clinical trial of HC-1119.
16. Use of an investigational agent within four weeks of enrollment (Day 1 visit).
17. Radiation therapy for treatment of the primary tumor within three weeks of enrollment (Day 1 visit).
18. Radionuclide therapy (Radium 223) for treatment of metastasis within four weeks of enrollment (Day 1 visit).
19. Clinically significant cardiovascular disease or condition
20. Treatment with strong CYP2C8 inhibitors and inducers, CYP3A4 inducers, medications which are known to prolong the QT interval (see Appendix C).
21. History of seizure or any condition that may predispose to seizure.
22. Conditions that predispose subjects to increased risk for falls or fractures according to the discretion of the Investigator.
23. Gastrointestinal disorder affecting absorption (e.g., gastrectomy, active peptic ulcer disease within last three months).
24. Major surgery within four weeks prior to enrollment (Day 1 visit).
25. Have active infection with HBV measured by hepatitis B surface antigen (HBsAg) test, HCV measured by RNA test and HIV measured by antibody test.
26. Have known active tuberculosis.
27. Known hypersensitivity to HC-1119, enzalutamide, or any of the excipients.
28. Rare hereditary problems of fructose intolerance due to sorbitol
Minimum Eligible Age
18 Years
Eligible Sex
MALE
Accepts Healthy Volunteers
No
Sponsors
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Hinova Pharmaceuticals USA, Inc.
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Locations
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Urology Center of Colorado, 2777 Mile High Stadium Circle
Denver, Colorado, United States
Site Status
Urologic Surgeons of Washington
Washington D.C., District of Columbia, United States
Site Status
First Urology PSC, 101 Hospital Boulevard
Jeffersonville, Indiana, United States
Site Status
Clinical Research Solutions PC
Middleburg Heights, Ohio, United States
Site Status
MidLantic Urology
Bala-Cynwyd, Pennsylvania, United States
Site Status
Keystone Urology Specialists
Lancaster, Pennsylvania, United States
Site Status
Urology San Antonio Stone Oak, 18915 Meisner Drive
San Antonio, Texas, United States
Site Status
Providence Regional Cancer System
Lacey, Washington, United States
Site Status
Icon Cancer Care Gold Coast
Southport, Queensland, Australia
Site Status
Ashford Cancer Centre Research
Kurralta Park, South Australia, Australia
Site Status
Affinity Clinical Research
Nedlands, , Australia
Site Status
Kepler Universitätsklinikum Linz
Linz, , Austria
Site Status
Fe/Male Health Centre
Oakville, Ontario, Canada
Site Status
CIUSSS de l'Estrie-CHUS
Sherbrooke, Quebec, Canada
Site Status
Aalborg Universitetshospital
Aalborg, , Denmark
Site Status
Odense Universitetshospital
Odense C, , Denmark
Site Status
Helsinki University Hospital Comprehensive Cancer Center - PPDS
Helsinki, , Finland
Site Status
Oulun Yliopistollinen Sairaala
Oulu, , Finland
Site Status
Seinäjoen Keskussairaala
Seinäjoki, , Finland
Site Status
Tampereen yliopistollinen sairaala
Tampere, , Finland
Site Status
Hopital Foch
Suresnes, Hauts-de-Seine, France
Site Status
Centre Jean Bernard Clinique Victor Hugo
Le Mans, , France
Site Status
CHRU Lille
Lille, , France
Site Status
Centre Léon Berard
Lyon, , France
Site Status
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
Site Status
Hopital d'Instruction des Armées de Begin
Saint-Mandé, , France
Site Status
Urologische Studienpraxis
Nürtingen, Baden-Wurttemberg, Germany
Site Status
Universitätsklinikum Bonn
Bonn, , Germany
Site Status
Universitätsklinikum Tübingen
Tübingen, , Germany
Site Status
UroGynZentrum Wall
Wuppertal, , Germany
Site Status
Azienda Ospedaliera S Maria Di Terni
Terni, Umbria, Italy
Site Status
Azienda Ospedaliera Universitaria Integrata Di Verona
Verona, , Italy
Site Status
Canisius Wilhelmina Ziekenhuis
Nijmegen, Gelderland, Netherlands
Site Status
Catharina Hospital
Eindhoven, North Brabant, Netherlands
Site Status
Antonius Ziekenhuis
Sneek, Provincie Friesland, Netherlands
Site Status
Hagaziekenhuis
The Hague, South Holland, Netherlands
Site Status
Clinical Research Center Spolka z Ograniczona
Poznan, Greater Poland Voivodeship, Poland
Site Status
NZOZ Centrum Urologiczne Sp zoo
Mysłowice, Silesian Voivodeship, Poland
Site Status
Onko-Centrum Sp. z o.o.
Lublin, , Poland
Site Status
Urologica Praktyka Lekarska Adam Marcheluk
Siedlce, , Poland
Site Status
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy
Warsaw, , Poland
Site Status
Altay Regional Oncology Center
Barnaul, , Russia
Site Status
Ivanovo Regional Oncology Dispensary
Ivanovo, , Russia
Site Status
Federal State Institution Medical Radiology Research Center
Obninsk, , Russia
Site Status
Clinical Oncology Dispensary
Omsk, , Russia
Site Status
First St. Petersburg State Medical University n.a. I.P Pavlov
Saint Petersburg, , Russia
Site Status
GBUZ Saint Petersburg Clinical Research Center of Specialized Types of Care (Oncology)
Saint Petersburg, , Russia
Site Status
Hospital Orkli LLC
Saint Petersburg, , Russia
Site Status
C.H. Regional Reina Sofia - PPDS
Córdoba, , Spain
Site Status
Hospital Lucus Augusti
Lugo, , Spain
Site Status
Hospital Universitario 12 de Octubre
Madrid, , Spain
Site Status
Hospital Regional Universitario de Malaga - Hospital Civil
Málaga, , Spain
Site Status
Hospital Universitario Virgen del Rocio - PPDS
Seville, , Spain
Site Status
Fundacion Instituto Valenciano de Oncologia
Valencia, , Spain
Site Status
Diana Princess of Wales Hospital
Grimsby, South Humberside, United Kingdom
Site Status
Belfast City Hospital
Belfast, , United Kingdom
Site Status
Royal Marsden Hospital - London
London, , United Kingdom
Site Status
Mount Vernon Hospital
Northwood, , United Kingdom
Site Status
Countries
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United States
Australia
Austria
Canada
Denmark
Finland
France
Germany
Italy
Netherlands
Poland
Russia
Spain
United Kingdom
Other Identifiers
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HC1119-CS-03
Identifier Type: -
Identifier Source: org_study_id
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