Trial to Optimally Show the Pharmacological Action of Z-100

Zeria Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Cervical Cancer

Treatments: Drug: Placebos; Drug: Z-100

Study type: Interventional

Funder types: Industry

Identifiers

NCT03476018

Z100-02

Details and patient eligibility

About

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

Enrollment: 72 patients

Sex: Female

Ages: 21 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. FIGO stage (2008): IIIB, cervical cancer
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

1. Subjects who have a double cancer or are being treated for that
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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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72 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebos

0.2 microgram Z-100

Experimental group

Treatment:

Drug: Z-100

2 microgram Z-100

Experimental group

Treatment:

Drug: Z-100

20 microgram Z-100

Experimental group

Treatment:

Drug: Z-100