Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2025-12-26 @ 3:10 AM
Study NCT ID:
NCT04784520
Status:
TERMINATED
Last Update Posted:
2023-02-06
First Post:
2021-03-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of HA121-28 Tablets in Advanced Biliary Tract Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001661', 'term': 'Biliary Tract Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'whyStopped': 'The primary endpoint did not meet expectation.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-06-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-12-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-02', 'studyFirstSubmitDate': '2021-03-02', 'studyFirstSubmitQcDate': '2021-03-03', 'lastUpdatePostDateStruct': {'date': '2023-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'adverse events incidence', 'timeFrame': 'Approximately 3.5 years'}, {'measure': 'HA121-28 plasma concentration', 'timeFrame': 'Approximately 3.5 years'}], 'primaryOutcomes': [{'measure': 'progression-free survival', 'timeFrame': 'Approximately 3.5 years'}], 'secondaryOutcomes': [{'measure': 'objective remission rate', 'timeFrame': 'Approximately 3.5 years'}, {'measure': 'overall survival', 'timeFrame': 'Approximately 3.5 years'}, {'measure': 'disease control rate', 'timeFrame': 'Approximately 3.5 years'}, {'measure': 'duration of response', 'timeFrame': 'Approximately 3.5 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Biliary Tract Cancer']}, 'descriptionModule': {'briefSummary': 'This study is a multicenter, open-label, single-arm phase II study to evaluate efficacy, safety, and pharmacokinetics characteristics of HA121-28 tablets in advanced biliary tract cancer (BTC). A total of approximately 30 subjects with advanced BTC will be enrolled. The subjects will undergo a 3 weeks-on and 1week-off treatment scheme with HA121-28 tablets 600 mg orally once daily in the 28-day cycle until disease progression or intolerable toxic reaction, whichever occurs first.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Be willing to participate in the clinical trial and sign the informed consent;\n* Histologically/cytologically confirmed unresectable locally advanced or metastatic BTC (including cholangiocarcinoma or gallbladder cancer) with failure of or intolerance to the prior therapy (including disease progression within 6 months after adjuvant chemotherapy) and with at least one measurable lesion based on RECIST 1.1 criteria;\n* Aged 18 to 75 years (inclusive);\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0\\~1;\n* Routine blood test results must meet the following criteria without blood transfusion within 14 days: 1) Hemoglobin (Hb)≥90 g/L; 2) Absolute neutrophil count (ANC)≥1.5 x 10\\^9/L; 3) Platelet count (PLT)≥75×10\\^9/L;\n* Coagulation test results must meet the following criteria: International Normalized Ratio (INR) \\<1.5 or Activated Partial Thromboplastin Time (APTT) \\<1.5×ULN;\n* Other laboratory test results must meet all the following criteria: 1) Total bilirubin (TBIL)≤1.5×ULN, Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)≤2.5×ULN (TBIL≤3×ULN, ALT and AST≤5×ULN in the subjects with liver metastasis); 2) Serum creatinine≤1.5×ULN；3) Serum albumin≥28g/L;\n* Male and female subjects of childbearing potential must agree to take effective contraception for the duration of treatment and for 6 months after completion of study drug administration; female subjects must have negative results of serum/urine pregnancy test within 7 days prior to enrollment and must not be breastfeeding.\n\nExclusion Criteria:\n\n* Subjects with ampullary carcinoma;\n* Subjects who had participated in other clinical trials and received the treatment within 4 weeks prior to enrolment;\n* The time interval between the end of the last antitumor treatment and the first administration of HA121-28 tablets \\< 4 weeks (for any antitumor treatment, including but not limited to chemotherapy, radiotherapy and targeted therapy), or \\< 2 weeks (for local palliative radiotherapy for pain relief or traditional Chinese medicine with approved indications for cancer);\n* Urine protein≥2+ and urine protein \\> 1.0g/24h;\n* History of other malignancies within the past 5 years prior to enrolment, except for cured cervical carcinoma in situ, non-melanoma skin cancer, superficial bladder tumor, and early esophageal and gastrointestinal cancers that were confined to the mucosal layer and resected under endoscopy;\n* History of any solid-organ or bone-marrow transplantation (except the transplantation without immunosuppression such as corneal and hair transplantation);\n* Unremitted toxic reaction\\>grade 1 due to any previous treatment at the time of enrollment (except for hair loss and pigmentation) which is considered to influence the safety evaluation;\n* ECG meets one of the following criteria: 1) QT/QTc interval≥450ms, congenital long QT syndrome (LQTS) or family history of LQTS; 2) any clinically significant abnormalities of rhythm, conduction or morphology in the resting ECG requiring therapeutic intervention;\n* Left ventricular ejection fraction (LVEF) \\<50% in echocardiogram;\n* Severe concomitant diseases which may have influence on the safety of the subjects or the completion of the study based on the investigator' judgement such as uncontrolled hypertension (systolic pressure ≥150 mmHg or diastolic pressure ≥100 mmHg after treatment);\n* High risk factors of gastrointestinal diseases such as gastrointestinal perforation and abdominal fistula;\n* Subjects with spinal cord, meningeal or brain metastasis (except for asymptomatic or stable brain metastasis within 4 weeks prior to administration);\n* Subjects with hepatopathy meet one of the following criteria: 1) HBsAg positive and HBV DNA \\>2000 IU/mL（or \\>1×10\\^4 copies/mL）; 2) HCV antibody positive and HCV RNA positive; 3) cirrhosis;\n* HIV antibody positive;\n* Subjects have history of surgery within 4 weeks prior to administration or have not been recovered from any previous invasive procedure, except for biliary stenting, biliary drainage, etc.;\n* Not suitable for the study in the investigator's opinion."}, 'identificationModule': {'nctId': 'NCT04784520', 'briefTitle': 'A Study of HA121-28 Tablets in Advanced Biliary Tract Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'CSPC ZhongQi Pharmaceutical Technology Co., Ltd.'}, 'officialTitle': 'A Multicentre, Open-label, Single-arm Phase II Study of HA121-28 Tablets in Advanced Biliary Tract Cancer (BTC)', 'orgStudyIdInfo': {'id': 'HA122-CSP-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HA121-28 tablets', 'description': 'HA121-28 600 mg, po, QD×21 days, every 4 weeks (28 days)', 'interventionNames': ['Drug: HA121-28 tablets']}], 'interventions': [{'name': 'HA121-28 tablets', 'type': 'DRUG', 'description': 'HA121-28 600 mg, po, QD×21 days, every 4 weeks (28 days)', 'armGroupLabels': ['HA121-28 tablets']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'The First Affiliated Hospital，Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Guanzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Sun Yat-sen University Cancer Center', 'geoPoint': {'lat': 23.06828, 'lon': 113.37117}}], 'overallOfficials': [{'name': 'Ruihua Xu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sun Yat-sen University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CSPC ZhongQi Pharmaceutical Technology Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}