Ignite Creation Date:
2025-12-24 @ 11:17 PM
Ignite Modification Date:
2026-01-19 @ 4:27 PM
Study NCT ID:
NCT03774056
Status:
COMPLETED
Last Update Posted:
2020-11-03
First Post:
2018-12-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study Evaluating Tolerability, Pharmacokinetics, and Preliminary Efficacy of HC-1119 in Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C540278', 'term': 'enzalutamide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-30', 'studyFirstSubmitDate': '2018-12-11', 'studyFirstSubmitQcDate': '2018-12-11', 'lastUpdatePostDateStruct': {'date': '2020-11-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose-limiting toxicities(DLT)', 'timeFrame': 'From the first dose of the study to the 12th week after dose', 'description': 'Safety measures'}, {'measure': 'Number of patients with adverse events', 'timeFrame': 'From the first dose of the study to the 12th week after dose', 'description': 'Safety measures'}], 'secondaryOutcomes': [{'measure': 'Maximum drug concentration(Cmax)', 'timeFrame': 'From the first dose of the study to the 12th week after dose', 'description': 'Single-dose and repeated-dose'}, {'measure': 'Time of maximum drug concentration(Tmax)', 'timeFrame': 'From the first dose of the study to the 12th week after dose', 'description': 'Single-dose and repeated-dose'}, {'measure': 'Area under curve from time 0 to 24h (AUC0-24h)', 'timeFrame': 'From the first dose of the study to the 12th week after dose', 'description': 'Single-dose and repeated-dose'}, {'measure': 'Maximal PSA Response Rate', 'timeFrame': 'From the first dose of the study to the 12th week after dose', 'description': 'Percentage of patients with \\> 50% decrease in PSA levels from baseline during the 12-week treatment period'}, {'measure': 'Response rate of prostate specific antigen (PSA)', 'timeFrame': 'From the first dose of the study to the 12th week after dose', 'description': 'Percentage of patients with \\> 50% decrease in PSA levels from baseline at weeks 6, 8, 10, and 12.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Metastatic Castration Resistant Prostate Cancer']}, 'referencesModule': {'references': [{'pmid': '34109624', 'type': 'DERIVED', 'citation': 'Li X, Cheng K, Li X, Zhou Y, Liu J, Zeng H, Chen Y, Liu X, Zhang Y, Wang Y, Bi F, Zheng L. Phase I clinical trial of HC-1119: A deuterated form of enzalutamide. Int J Cancer. 2021 Oct 1;149(7):1473-1482. doi: 10.1002/ijc.33706. Epub 2021 Jul 7.'}]}, 'descriptionModule': {'briefSummary': 'This is a phase I study evaluating tolerability, pharmacokinetics, and preliminary efficacy of HC-1119 in patients with metastatic castration-resistant prostate cancer. The study objective is to study the tolerability, safety, and dose-limiting toxicities (DLT) of HC-1119 in patients with mCRPC.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria (those who meet all of the following are eligible):\n\n1. Voluntarily participated in the study, with understanding of relevant study procedures and signed informed consent form;\n2. Male , ≥18 years old;\n3. With histologically or cytologically confirmed prostate cancer, without neuroendocrine carcinoma or ductal adenocarcinoma;\n4. With evidence of metastatic disease (such as bone scan and CT/MRI results);\n5. 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: Serum 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 disease progression defined by PCWG2 with 2 or more new metastatic lesions on bone scan);\n6. Castrate levels of testosterone (\\< 50 ng/dl) at screening;\n7. Bilateral orchiectomy or ongoing androgen deprivation therapy with effective GnRH analogues;\n8. Estimated life expectancy \\> 6 months;\n9. ECOG performance status ≤ 1;\n10. Laboratory tests must meet the following criteria:\n\n 1. Routine Blood Test: hemoglobin (Hb) ≥ 90 g/L (no blood transfusion within the last 14 days); absolute neutrophil count (ANC) ≥ 1.5 x 109/L; platelet count (PLT) ≥ 80 x 109/L;\n 2. 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);\n 3. Coagulation: INR \\< 1.5.\n\nExclusion Criteria (those who meet any one of the following are ineligible):\n\n1. Ongoing toxicity ( ≥ Grade 2 toxicity) from previous treatments;\n2. Clinically 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;\n3. History of allergies, or known hypersensitivity to components of the investigational drug;\n4. Brain metastases;\n5. Other malignancies within the last 5 years (except for curatively treated non-melanoma skin cancer);\n6. History of organ transplants\n7. HIV seropositive;\n8. Past medical history of seizures or serious CNS diseases;\n9. History of unexplained coma;\n10. Family history of seizures;\n11. History of traumatic brain injury;\n12. History of medication or drug abuse;\n13. Patients with severe cardiovascular diseases, including those with myocardial infarction, arterial thrombosis, unstable angina, or clinical symptomatic heart failure within the past 6 months;\n14. Uncontrolled hypertension (systolic ≥ 160 mmHg or diastolic ≥ 100 mmHg). Patients with a history of hypertension is eligible if his blood pressure is controlled with antihypertensives;\n15. Medications that lower the seizure threshold must be used during the study;\n16. Treatment with 5α-reductase inhibitors (finasteride, dutasteride), estrogen, or cyproterone within the past 4 weeks;\n17. Treatment with ketoconazole within the past 4 weeks;\n18. Previously treated with investigational or approved medications that inhibit testosterone synthesis (such as abiraterone acetate, TAK-683, and TAK-448) or target testosterone receptors (such as enzalutamide, SHR3680, proxalutamide, and ARN509);\n19. Participated in other clinical trials within 1 month prior to enrollment;\n20. Subjects is determined by the investigator to be unsuitable for this study.'}, 'identificationModule': {'nctId': 'NCT03774056', 'briefTitle': 'A Study Evaluating Tolerability, Pharmacokinetics, and Preliminary Efficacy of HC-1119 in Patients.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hinova Pharmaceuticals Inc.'}, 'officialTitle': 'A Phase I Study Evaluating Tolerability, Pharmacokinetics, and Preliminary Efficacy of HC-1119 in Patients With Metastatic Castration-Resistant Prostate Cancer.', 'orgStudyIdInfo': {'id': 'HC-1119-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'dose group', 'description': 'Drug name L:HC-1119 Dosage: 40 mg, 80 mg, 160 mg, and 200 mg', 'interventionNames': ['Drug: HC-1119']}], 'interventions': [{'name': 'HC-1119', 'type': 'DRUG', 'description': 'oral', 'armGroupLabels': ['dose group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '610041', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': 'Hinova Pharmaceuticals Inc.', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}], 'overallOfficials': [{'name': 'Feng Bi, professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'West China Hospital'}, {'name': 'Li Zheng, professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'West China Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hinova Pharmaceuticals Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'West China Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}