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Trial to Optimally Show the Pharmacological Action of Z-100

Primary Purpose

Cervical Cancer

Status
Completed
Phase
Phase 3
Locations
Vietnam
Study Type
Interventional
Intervention
Z-100
Placebos
Sponsored by
Zeria Pharmaceutical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Cervical Cancer

Eligibility Criteria

21 Years - 79 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Zeria Investrigative Sites
  • Zeria Investigative sites

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Placebo

0.2 microgram Z-100

2 microgram Z-100

20 microgram Z-100

Arm Description

Outcomes

Primary Outcome Measures

Change in the number of immunological cells

Secondary Outcome Measures

Overall survival
Disease-specific survival
Recurrence-free survival
Rate of adverse events/adverse drug reactions

Full Information

First Posted
March 4, 2018
Last Updated
June 14, 2022
Sponsor
Zeria Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT03476018
Brief Title
Trial to Optimally Show the Pharmacological Action of Z-100
Official Title
Z-100 Pharmacological Trial: A Randomised Placebo-controlled Trial of Z-100 Plus Radiation Therapy in Subjects With Locally Advanced Cervical Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
April 2, 2018 (Actual)
Primary Completion Date
July 20, 2021 (Actual)
Study Completion Date
December 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zeria Pharmaceutical

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
0.2 microgram Z-100
Arm Type
Experimental
Arm Title
2 microgram Z-100
Arm Type
Experimental
Arm Title
20 microgram Z-100
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Z-100
Intervention Description
Twice a week until 29 days after completion of chemoradiotherapy, then once every 14 days
Intervention Type
Drug
Intervention Name(s)
Placebos
Intervention Description
Twice a week until 29 days after completion of chemoradiotherapy, then once every 14 days
Primary Outcome Measure Information:
Title
Change in the number of immunological cells
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
3 years
Title
Disease-specific survival
Time Frame
2 years
Title
Recurrence-free survival
Time Frame
3 years
Title
Rate of adverse events/adverse drug reactions
Time Frame
2 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Facility Information:
Facility Name
Zeria Investrigative Sites
City
Hanoi
Country
Vietnam
Facility Name
Zeria Investigative sites
City
Ho Chi Minh City
Country
Vietnam

12. IPD Sharing Statement

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Trial to Optimally Show the Pharmacological Action of Z-100

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