Trial to Optimally Show the Pharmacological Action of Z-100

NCT03476018 | Completed Phase 3

• 1 other identifier: Z100-02
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

Cervical Cancer

Outcome Measures

Primary Outcomes (1)

• Change in the number of immunological cells

  2 years

Secondary Outcomes (4)

• Overall survival

  3 years

• Disease-specific survival

  2 years

• Recurrence-free survival

  3 years

• Rate of adverse events/adverse drug reactions

  2 years

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Drug: Placebos

0.2 microgram Z-100

EXPERIMENTAL

Drug: Z-100

2 microgram Z-100

EXPERIMENTAL

Drug: Z-100

20 microgram Z-100

EXPERIMENTAL

Drug: Z-100

Interventions

Z-100 DRUG

Twice a week until 29 days after completion of chemoradiotherapy, then once every 14 days

0.2 microgram Z-100; 2 microgram Z-100; 20 microgram Z-100

Placebos DRUG

Twice a week until 29 days after completion of chemoradiotherapy, then once every 14 days

Placebo

Eligibility Criteria

• Age: 21 Years - 79 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• FIGO stage (2008): IIIB, cervical cancer
• Pathologically confirmed squamous cell carcinoma of the cervix
• Subjects with treatment-naive cervical cancer
• Subjects without enlargement (≥15 mm in the short axis) in the lower abdominal para-aortic lymph node
• Subjects ≥21, ≤79 years of age at informed consent
• Subjects for whom it is considered possible to carry out intracavitary radiation in radiotherapy
• Subjects for whom it is considered possible to carry out concurrent cisplatin treatment with radiotherapy
• Eastern Cooperative Oncology Group Performance Status: 0-2
• 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
• Subjects who are willing to give informed consent

You may not qualify if:

• Subjects who have a double cancer or are being treated for that
• Subjects who have suffered from cancers other than cervical cancer within 5 years prior to obtaining consent
• Subjects with cancer of the cervical stump which is judged by the investigator
• Subjects who have a history of being diagnosed of autoimmune disease
• Subjects who have a history of radiotherapy in the pelvis
• Subjects who have a history of hypersensitivity to cisplatin or other medical agents which contain platinum
• Subjects complicated with a serious drug allergy
• Subjects with a serious complication (poorly controlled hypertension, haemorrhagic tendency, connective tissue disease being treated with steroid)
• Pregnant women, nursing mothers or subjects who desire pregnancy during the trial period
• Subjects who have ongoing infection of human immunodeficiency virus (HIV), active hepatitis B virus (HBV), hepatitis C virus (HCV)
• Subjects with symptomatic tuberculosis at the date of obtaining consent
• Subjects who have received any other investigational medicinal products or medical devices within 28 days prior to obtaining consent
• Other subjects considered inappropriate to participate in the trial by the investigator

Sponsors & Collaborators

• Zeria Pharmaceutical: lead

Study Sites (2)

Zeria Investrigative Sites

Hanoi, Vietnam

Location

Zeria Investigative sites

Ho Chi Minh City, Vietnam

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

specific substance maruyama

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2018
• First Posted: March 23, 2018
• Study Start: April 2, 2018
• Primary Completion: July 20, 2021
• Study Completion: December 10, 2021
• Last Updated: June 16, 2022

Record last verified: 2022-06

Locations

VN (2)