Trial to Optimally Show the Pharmacological Action of Z-100
NCT ID: NCT03476018
Last Updated: 2022-06-16
Study Results
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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COMPLETED
PHASE3
72 participants
INTERVENTIONAL
2018-04-02
2021-12-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
QUADRUPLE
Study Groups
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Placebo
Placebos
Twice a week until 29 days after completion of chemoradiotherapy, then once every 14 days
0.2 microgram Z-100
Z-100
Twice a week until 29 days after completion of chemoradiotherapy, then once every 14 days
2 microgram Z-100
Z-100
Twice a week until 29 days after completion of chemoradiotherapy, then once every 14 days
20 microgram Z-100
Z-100
Twice a week until 29 days after completion of chemoradiotherapy, then once every 14 days
Interventions
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Z-100
Twice a week until 29 days after completion of chemoradiotherapy, then once every 14 days
Placebos
Twice a week until 29 days after completion of chemoradiotherapy, then once every 14 days
Eligibility Criteria
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Inclusion Criteria
2. Pathologically confirmed squamous cell carcinoma of the cervix
3. Subjects with treatment-naive cervical cancer
4. Subjects without enlargement (≥15 mm in the short axis) in the lower abdominal para-aortic lymph node
5. Subjects ≥21, ≤79 years of age at informed consent
6. Subjects for whom it is considered possible to carry out intracavitary radiation in radiotherapy
7. Subjects for whom it is considered possible to carry out concurrent cisplatin treatment with radiotherapy
8. Eastern Cooperative Oncology Group Performance Status: 0-2
9. 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
10. Subjects who are willing to give informed consent
Exclusion Criteria
2. Subjects who have suffered from cancers other than cervical cancer within 5 years prior to obtaining consent
3. Subjects with cancer of the cervical stump which is judged by the investigator
4. Subjects who have a history of being diagnosed of autoimmune disease
5. Subjects who have a history of radiotherapy in the pelvis
6. Subjects who have a history of hypersensitivity to cisplatin or other medical agents which contain platinum
7. Subjects complicated with a serious drug allergy
8. Subjects with a serious complication (poorly controlled hypertension, haemorrhagic tendency, connective tissue disease being treated with steroid)
9. Pregnant women, nursing mothers or subjects who desire pregnancy during the trial period
10. Subjects who have ongoing infection of human immunodeficiency virus (HIV), active hepatitis B virus (HBV), hepatitis C virus (HCV)
11. Subjects with symptomatic tuberculosis at the date of obtaining consent
12. Subjects who have received any other investigational medicinal products or medical devices within 28 days prior to obtaining consent
13. Other subjects considered inappropriate to participate in the trial by the investigator
21 Years
79 Years
FEMALE
No
Sponsors
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Zeria Pharmaceutical
INDUSTRY
Responsible Party
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Locations
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Zeria Investrigative Sites
Hanoi, , Vietnam
Zeria Investigative sites
Ho Chi Minh City, , Vietnam
Countries
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Other Identifiers
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Z100-02
Identifier Type: -
Identifier Source: org_study_id
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