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

NCT02195089 | Completed Phase 1

• 2 other identifiers: UMT2013-BLS-ILB-E710c12591
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 5

Brief 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).

Conditions

Cervical Intraepithelial Neoplasia

Keywords

Treatment of Cervical Intraepithelial Neoplasia(CIN3)

Outcome Measures

Primary Outcomes (2)

• Phase 1 : Safety

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

  up to 9 weeks

• 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

  screening and 9 weeks(option), 16 weeks.

Secondary Outcomes (3)

• Reid Colposcopic Index

  Phase 1 : up to 9 weeks

• Reid Colposcopic Index

  Phase 2a : up to 16 weeks

• Serum anti-E7 antibody

  1 week, 9 weeks, 16 weeks

Study Arms (3)

BLS_ILB_E710c 500mg

EXPERIMENTAL

* Drug: BLS\_ILB\_E710c 500mg * Dosage and duration: 2 capsules per day for 20 days (week 1,2,4 \& 8)

Drug: BLS_ILS_E710c 500mg

BLS_ILS_E710c 1000mg

EXPERIMENTAL

* Drug: BLS\_ILS\_E710c 1000mg * Dosage and duration: 4 capsules per day for 20 days (week 1,2,4 \& 8)

Drug: BLS_ILB_710c 1000mg

BLS_ILS_E710c 1500mg

EXPERIMENTAL

* Drug: BLS\_ILS\_E710c 1500mg * Dosage and duration: 6 capsules per day for 20 days (week 1,2,4 \& 8)

Drug: BLS_ILS_E710c 1500mg

Interventions

BLS_ILS_E710c 500mg DRUG

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

Also known as: CIN3 Theraputic Vaccine

BLS_ILB_E710c 500mg

BLS_ILB_710c 1000mg DRUG

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

Also known as: CIN3 Theraputic Vaccine

BLS_ILS_E710c 1000mg

BLS_ILS_E710c 1500mg DRUG

\- 6 capsules per day for 8 weeks (week 1,2,4 \& 8)

Also known as: CIN3 Theraputic Vaccine

BLS_ILS_E710c 1500mg

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• BioLeaders Corporation: lead

Study Sites (5)

Korea University Guro Hospital

Seoul, Seoul, 152-703, South Korea

Location

The Dongsan Medical Center of Keimyung University

Daegu, 700-712, South Korea

Location

Kwandong University College of Medicine Cheil Hospital

Seoul, 100-380, South Korea

Location

The Catholic University, Korea Seoul St Mary's Hospital

Seoul, 137-701, South Korea

Location

Asan Medical Center

Seoul, 138-736, South Korea

Location

Related Publications (1)

• 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.

  PMID: 31576684 DERIVED

MeSH Terms

Conditions

Uterine Cervical Dysplasia

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Jae-Kwan Lee, MD, PhD

  Korea University Guro Hospital

  PRINCIPAL INVESTIGATOR

• Tae Jin Kim, MD, PhD

  Kwandong University College of Medicine Cheil Hospital

  PRINCIPAL INVESTIGATOR

• Jong Sup Park, MD, PhD

  The Catholic University, Korea Seoul St Mary's Hospital

  PRINCIPAL INVESTIGATOR

• Chi-Heum Cho, MD, PhD

  The Dongsan Medical Center of Keimyung University

  PRINCIPAL INVESTIGATOR

• Jong Hyeok Kim, MD, PhD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2014
• First Posted: July 21, 2014
• Study Start: March 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: April 1, 2016
• Last Updated: April 19, 2016

Record last verified: 2016-04

Locations

KR (5)