Trial to Optimally Show the Pharmacological Action of Z-100

Cervical Cancer Clinical Trial

Official title:

Z-100 Pharmacological Trial: A Randomised Placebo-controlled Trial of Z-100 Plus Radiation Therapy in Subjects With Locally Advanced Cervical Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03476018
• Other study ID #: Z100-02
• Status: Completed
• Phase: Phase 3
• Start date: April 2, 2018
• Est. completion date: December 10, 2021

Study information

• Verified date: June 2022
• Source: Zeria Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: December 10, 2021
• Est. primary completion date: July 20, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Vietnam	Zeria Investrigative Sites	Hanoi
Vietnam	Zeria Investigative sites	Ho Chi Minh City

Sponsors (1)

Lead Sponsor	Collaborator
Zeria Pharmaceutical

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the number of immunological cells		2 years
Secondary	Overall survival		3 years
Secondary	Disease-specific survival		2 years
Secondary	Recurrence-free survival		3 years
Secondary	Rate of adverse events/adverse drug reactions		2 years