Cervical CancerPhase 3NCT03476018
Trial to Optimally Show the Pharmacological Action of Z-100
A Phase 3 study testing Z-100 in people with Cervical Cancer, run by Zeria Pharmaceutical at 2 sites in Vietnam.
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 Read more about this study
- Who is it for?
- Ages 21 to 79 years, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Z-100
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 2 sitesVietnam
- Study dates
- 2 Apr 2018to 10 Dec 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 79 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
Vietnam2 sites
Zeria Investrigative Sites
Hanoi
Zeria Investigative sites
Ho Chi Minh City
About this study
Official title: Z-100 Pharmacological Trial: A Randomised Placebo-controlled Trial of Z-100 Plus Radiation Therapy in Subjects With Locally Advanced Cervical Cancer
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
- Being tested
- Z-100, Placebos
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Z-100Drug
Twice a week until 29 days after completion of chemoradiotherapy, then once every 14 days
PlacebosDrug
Twice a week until 29 days after completion of chemoradiotherapy, then once every 14 days
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebos |
| 0.2 microgram Z-100 | Experimental | Not described Receives: Drug: Z-100 |
| 2 microgram Z-100 | Experimental | Not described Receives: Drug: Z-100 |
| 20 microgram Z-100 | Experimental | Not described Receives: Drug: Z-100 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the number of immunological cells
Measured: 2 years
Secondary outcomes (4)
Overall survival
Measured: 3 years
Disease-specific survival
Measured: 2 years
Recurrence-free survival
Measured: 3 years
Rate of adverse events/adverse drug reactions
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2018
- Study start2 Apr 2018
- Primary completion20 Jul 2021
- Study completion10 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zeria Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03476018
- Sponsor's protocol ID
- Z100-02
- Status last verified
- Jun 2022
- First submitted
- 4 Mar 2018
- Last updated
- 16 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Z-100 Pharmacological Trial: A Randomised Placebo-controlled Trial of Z-100 Plus Radiation Therapy in Subjects With Locally Advanced Cervical Cancer
- ClinicalTrials.gov ID
- NCT03476018
- Acronym / sponsor ID
- Z100-02
- Conditions
- Cervical Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Zeria PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 2 Apr 2018 (actual)
- Primary completion
- 20 Jul 2021 (actual)
- Study completion
- 10 Dec 2021 (actual)
- First posted
- 23 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 21 to 79 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Z-100Twice a week until 29 days after completion of chemoradiotherapy, then once every 14 days | Drug | 0.2 microgram Z-100, 2 microgram Z-100, 20 microgram Z-100 |
| PlacebosTwice a week until 29 days after completion of chemoradiotherapy, then once every 14 days | Drug | Placebo |
Primary outcome
Change in the number of immunological cells
Time frame: 2 years
4 secondary outcomes
Overall survival
Time frame: 3 years
Disease-specific survival
Time frame: 2 years
Recurrence-free survival
Time frame: 3 years
Rate of adverse events/adverse drug reactions
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Z-100 in people with Cervical Cancer, run by Zeria Pharmaceutical at 2 sites in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the number of immunological cells (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2022.