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Cervical Intraepithelial NeoplasiaPhase 1/2NCT02195089

Efficacy and Safety Study of BLS_ILB_E710c for the Fertile Women With Cervical Intraepithelial Neoplasia(CIN3)

A Phase 1/2 study testing BLS_ILS_E710c 500mg, BLS_ILB_710c 1000mg and BLS_ILS_E710c 1500mg in people with Cervical Intraepithelial Neoplasia, run by BioLeaders Corporation at 5 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine the efficacy and the safety of BLS-ILB-E710c for the the fertile women with Cervical Intraepithelial Neoplasia (CIN3). Read more about this study

Who is it for?
Ages 20 to 50 years, women only
Conditions the study is for
Cervical Intraepithelial Neoplasia
What is being tested?
BLS_ILS_E710c 500mg, BLS_ILB_710c 1000mg and BLS_ILS_E710c 1500mg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
5 sitesSouth Korea
Study dates
Mar 2014to Apr 2016
Phase
Phase 1/2
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 20 to 50 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Pre-menopausal patients between age of 20 and 50.
  • Patients with cervical intraepithelial neoplasia 3(CIN3).
  • Only infection with HPV type 16.
  • Patients with Capable of observation of all of lesions by Colposcopy biopsy.
  • Be informed of the nature of the study and will give written informed consent.
  • Be agree with contraception during study
Show all 9Show fewer
  • White Blood Cell Count(WBC) over 4thous/ul, Hemoglobin above over 9.0g/dL Platelet over 150thous/uL and ANC(Absolute Neutrophil Count) over 1,500 /mm^3
  • Normal for EKG(Electrocardiography)
  • AST/ALT : 2.5 times less than normal range

Who cannot join

  • Autoimmune Disease or Prohibited drug(Therapy) bring about immunosuppressive.
  • Patient that has medical history of hypersensitivity about Food containing Lactic acid bacteria or Lactic acid bacteria medication.
  • Patient with Acute illness(ex. Acute Appendicitis, Myocardial infarction, Hemorrhage, meningitis etc.)
  • Investigational product within three months before the start of the drug administration to patients treated with other test drug.
  • Patient with Chronic pancreatitis currently or Patients diagnosed with acute pancreatitis.
  • Organopathy Patient with Inflammatory intestine·bowel disease, gastrointestinal tumors, ulcers, bleeding, perforation etc.
Show all 10Show fewer
  • Pregnant or lactating women
  • Patient with HBV or HCV infection (except for Asymptomatic)
  • Patient that Investigator judge
  • Deemed inappropriate for researchers to judge the patient

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

South Korea5 sites

  • The Dongsan Medical Center of Keimyung University

    Daegu, 700-712

  • Korea University Guro Hospital

    Seoul, Seoul, 152-703

  • Kwandong University College of Medicine Cheil Hospital

    Seoul, 100-380

  • The Catholic University, Korea Seoul St Mary's Hospital

    Seoul, 137-701

  • Asan Medical Center

    Seoul, 138-736

Other trials in South Korea

About this study

Official title: A Phase 1/2a Trial to Evaluate the Efficacy and the Safety of BLS_ILB_E710c for the Fertile Women With Cervical Intraepithelial Neoplasia(CIN3)

The purpose of this study is to determine the efficacy and the safety of BLS-ILB-E710c for the the fertile women with Cervical Intraepithelial Neoplasia (CIN3).

Read the detailed description

This study is to see the regression rate of Cervical Intraepithelial Neoplasia (CIN3) and to see the inducement of Cytotoxic T Lymphocyte.

The First treatment group will be administered with BLS-ILB-E710c 500mg for 8 weeks followed by 1 week observation The Second treatment group will be administered with BLS-ILB-E710c 1000mg for 8 weeks followed by 1 week observation The Third treatment group will be administered with BLS-ILB-E710c 1500mg for 8 weeks followed by 1 week observation The fourth treatment group will be administered with BLS-ILB-E710c Optimum dose for 8 weeks followed by 8 weeks observation

Being tested
BLS_ILS_E710c 500mg, BLS_ILB_710c 1000mg, BLS_ILS_E710c 1500mg
Keywords
Treatment of Cervical Intraepithelial Neoplasia(CIN3)
Medical subject headings
Uterine Cervical Dysplasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BLS_ILS_E710c 500mgDrug

    Also called CIN3 Theraputic Vaccine

    • 2 capsules per day for 20 days (week 1,2,4 \& 8)

  • BLS_ILB_710c 1000mgDrug

    Also called CIN3 Theraputic Vaccine

    • 4 capsules per day for 20 days (week 1,2,4 \& 8)

  • BLS_ILS_E710c 1500mgDrug

    Also called CIN3 Theraputic Vaccine

    • 6 capsules per day for 8 weeks (week 1,2,4 \& 8)
Study groups in NCT02195089
Study groupRoleWhat they receive
BLS_ILB_E710c 500mgExperimental* Drug: BLS_ILB_E710c 500mg * Dosage and duration: 2 capsules per day for 20 days (week 1,2,4 \& 8)
Receives: Drug: BLS_ILS_E710c 500mg
BLS_ILS_E710c 1000mgExperimental* Drug: BLS_ILS_E710c 1000mg * Dosage and duration: 4 capsules per day for 20 days (week 1,2,4 \& 8)
Receives: Drug: BLS_ILB_710c 1000mg
BLS_ILS_E710c 1500mgExperimental* Drug: BLS_ILS_E710c 1500mg * Dosage and duration: 6 capsules per day for 20 days (week 1,2,4 \& 8)
Receives: Drug: BLS_ILS_E710c 1500mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase 1 : Safety

    Dose Limiting Toxicity(DLT) is assessed by NCI-CTC version 4.0

    Measured: up to 9 weeks

  2. Phase 2a : Regression rate

    Regression rate will be assessed at the time of screening and 9 weeks(option), 16 weeks. Regression means the change from the stage of CIN1 to normal

    Measured: screening and 9 weeks(option), 16 weeks.

Secondary outcomes (3)

  1. Reid Colposcopic Index

    Reid Colposcopic Index will be assessed at the time of screening,4 weeks 9.

    Measured: Phase 1 : up to 9 weeks

  2. Reid Colposcopic Index

    Reid Colposcopic Index will be assessed at the time of screening,4 weeks, 9 weeks, 12 weeks, 16 weeks

    Measured: Phase 2a : up to 16 weeks

  3. Serum anti-E7 antibody

    Serum anti-E7 antibody will be assessed at the time of 1 week, 9 weeks, 16 weeks.

    Measured: 1 week, 9 weeks, 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2014 (estimated)
  2. Study startMar 2014
  3. Primary completionMar 2016
  4. Study completionApr 2016

Resources

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02195089
Sponsor's protocol ID
UMT2013-BLS-ILB-E710c
Other IDs
12591
Status last verified
Apr 2016
First submitted
15 Jul 2014
Last updated
19 Apr 2016
Results posted
No
Data monitoring committee
No

Publications

  • Park YC, Ouh YT, Sung MH, Park HG, Kim TJ, Cho CH, Park JS, Lee JK. A phase 1/2a, dose-escalation, safety and preliminary efficacy study of oral therapeutic vaccine in subjects with cervical intraepithelial neoplasia 3. J Gynecol Oncol. 2019 Nov;30(6):e88. doi: 10.3802/jgo.2019.30.e88.

    PubMed 31576684

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing BLS_ILS_E710c 500mg, BLS_ILB_710c 1000mg and BLS_ILS_E710c 1500mg in people with Cervical Intraepithelial Neoplasia, run by BioLeaders Corporation at 5 sites in South Korea.

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 9 inclusion and 10 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 19 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in South Korea. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Phase 1 : Safety (time frame: up to 9 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02195089, which also lists 1 linked publication.

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 19 Apr 2016.

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