Clinical Trial: Efficacy and Safety Study of BLS_ILB_E710c for the Fertile Women With Cervical Intraepithelial Neoplasia(CIN3)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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)
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).
Detailed Summary:
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
Sponsor: BioLeaders Corporation
Current Primary Outcome:
- Phase 1 : Safety [ Time Frame: up to 9 weeks ]Dose Limiting Toxicity(DLT) is assessed by NCI-CTC version 4.0
- Phase 2a : Regression rate [ Time Frame: screening and 9 weeks(option), 16 weeks. ]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
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Reid Colposcopic Index [ Time Frame: Phase 1 : up to 9 weeks ]Reid Colposcopic Index will be assessed at the time of screening,4 weeks 9.
- Reid Colposcopic Index [ Time Frame: Phase 2a : up to 16 weeks ]Reid Colposcopic Index will be assessed at the time of screening,4 weeks, 9 weeks, 12 weeks, 16 weeks
- Serum anti-E7 antibody [ Time Frame: 1 week, 9 weeks, 16 weeks ]Serum anti-E7 antibody will be assessed at the time of 1 week, 9 weeks, 16 weeks.
Original Secondary Outcome: Same as current
Information By: BioLeaders Corporation
Dates:
Date Received: July 15, 2014
Date Started: March 2014
Date Completion:
Last Updated: April 18, 2016
Last Verified: April 2016