Ignite Creation Date:
2025-12-25 @ 4:49 AM
Ignite Modification Date:
2025-12-26 @ 3:51 AM
Study NCT ID:
NCT03476018
Status:
COMPLETED
Last Update Posted:
2022-06-16
First Post:
2018-03-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Trial to Optimally Show the Pharmacological Action of Z-100
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C031208', 'term': 'specific substance maruyama'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2021-12-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-14', 'studyFirstSubmitDate': '2018-03-04', 'studyFirstSubmitQcDate': '2018-03-17', 'lastUpdatePostDateStruct': {'date': '2022-06-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the number of immunological cells', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '3 years'}, {'measure': 'Disease-specific survival', 'timeFrame': '2 years'}, {'measure': 'Recurrence-free survival', 'timeFrame': '3 years'}, {'measure': 'Rate of adverse events/adverse drug reactions', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cervical Cancer']}, 'descriptionModule': {'briefSummary': 'The objective of this clinical trial is to evaluate the change of the immunological parameter levels in FIGO stage IIIB cervical cancer subjects by administration of Z-100'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. FIGO stage (2008): IIIB, cervical cancer\n2. Pathologically confirmed squamous cell carcinoma of the cervix\n3. Subjects with treatment-naive cervical cancer\n4. Subjects without enlargement (≥15 mm in the short axis) in the lower abdominal para-aortic lymph node\n5. Subjects ≥21, ≤79 years of age at informed consent\n6. Subjects for whom it is considered possible to carry out intracavitary radiation in radiotherapy\n7. Subjects for whom it is considered possible to carry out concurrent cisplatin treatment with radiotherapy\n8. Eastern Cooperative Oncology Group Performance Status: 0-2\n9. Subjects with the following organ functions; (1) WBC ≥3,000/mm3 (2) Platelet count ≥100,000/mm3 (3) Hemoglobin ≥9.5 g/dL (correction by medication, e.g. blood transfusion, iron compounds, is allowed) (4) Total bilirubin ≤ three (3) times the upper limit of reference value at the clinical testing laboratory (5) AST, ALT ≤ three (3) times the upper limit of reference value at the clinical testing laboratory (6) Creatinine clearance: ≥50 mL/min\n10. Subjects who are willing to give informed consent\n\nExclusion Criteria:\n\n1. Subjects who have a double cancer or are being treated for that\n2. Subjects who have suffered from cancers other than cervical cancer within 5 years prior to obtaining consent\n3. Subjects with cancer of the cervical stump which is judged by the investigator\n4. Subjects who have a history of being diagnosed of autoimmune disease\n5. Subjects who have a history of radiotherapy in the pelvis\n6. Subjects who have a history of hypersensitivity to cisplatin or other medical agents which contain platinum\n7. Subjects complicated with a serious drug allergy\n8. Subjects with a serious complication (poorly controlled hypertension, haemorrhagic tendency, connective tissue disease being treated with steroid)\n9. Pregnant women, nursing mothers or subjects who desire pregnancy during the trial period\n10. Subjects who have ongoing infection of human immunodeficiency virus (HIV), active hepatitis B virus (HBV), hepatitis C virus (HCV)\n11. Subjects with symptomatic tuberculosis at the date of obtaining consent\n12. Subjects who have received any other investigational medicinal products or medical devices within 28 days prior to obtaining consent\n13. Other subjects considered inappropriate to participate in the trial by the investigator'}, 'identificationModule': {'nctId': 'NCT03476018', 'briefTitle': 'Trial to Optimally Show the Pharmacological Action of Z-100', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zeria Pharmaceutical'}, 'officialTitle': 'Z-100 Pharmacological Trial: A Randomised Placebo-controlled Trial of Z-100 Plus Radiation Therapy in Subjects With Locally Advanced Cervical Cancer', 'orgStudyIdInfo': {'id': 'Z100-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebos']}, {'type': 'EXPERIMENTAL', 'label': '0.2 microgram Z-100', 'interventionNames': ['Drug: Z-100']}, {'type': 'EXPERIMENTAL', 'label': '2 microgram Z-100', 'interventionNames': ['Drug: Z-100']}, {'type': 'EXPERIMENTAL', 'label': '20 microgram Z-100', 'interventionNames': ['Drug: Z-100']}], 'interventions': [{'name': 'Z-100', 'type': 'DRUG', 'description': 'Twice a week until 29 days after completion of chemoradiotherapy, then once every 14 days', 'armGroupLabels': ['0.2 microgram Z-100', '2 microgram Z-100', '20 microgram Z-100']}, {'name': 'Placebos', 'type': 'DRUG', 'description': 'Twice a week until 29 days after completion of chemoradiotherapy, then once every 14 days', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hanoi', 'country': 'Vietnam', 'facility': 'Zeria Investrigative Sites', 'geoPoint': {'lat': 21.0245, 'lon': 105.84117}}, {'city': 'Ho Chi Minh City', 'country': 'Vietnam', 'facility': 'Zeria Investigative sites', 'geoPoint': {'lat': 10.82302, 'lon': 106.62965}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zeria Pharmaceutical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}