PMID- 38330377
OWN - NLM
STAT- Publisher
LR  - 20240208
IS  - 2005-0399 (Electronic)
IS  - 2005-0380 (Linking)
DP  - 2024 Jan 24
TI  - A phase 1/2a, dose-escalation, safety, and preliminary efficacy study of the 
      RKP00156 vaginal tablet in healthy women and patients with cervical 
      intraepithelial neoplasia 2.
LID - 10.3802/jgo.2024.35.e52 [doi]
AB  - OBJECTIVE: This study aimed to determine the safety and efficacy of the RKP00156 
      vaginal tablet, a CDK9 inhibitor, in healthy women and patients with cervical 
      intraepithelial neoplasia grade 2 (CIN2). METHODS: We conducted a phase 1/2a 
      clinical trial of RKP00156. In step 1, RKP00156 at a dose of 10, 25, or 50 mg or 
      a placebo tablet was administered transvaginally to 24 healthy women. In step 2, 
      RKP00156 at a dose of 10, 25, or 50 mg or a placebo tablet was administered once 
      daily for 4 weeks in 62 patients with CIN2. The primary endpoints of this trial 
      were the safety of RKP00156 and the change in the human papillomavirus (HPV) 
      viral load. RESULTS: A total of 86 patients were enrolled and randomized. 
      RKP00156 administration did not cause serious drug-associated adverse events 
      (AEs). Although no significant difference in the HPV viral load was found between 
      the experimental and placebo groups, a reduction in the HPV viral load was 
      observed in the 25 mg-dose group (-98.61%; 95% confidence interval=-99.83%, 
      4.52%; p=0.046) after treatment completion in patients with a high HPV viral 
      load, despite a lack of statistical power. No differences in histologic 
      regression and HPV clearance were observed. CONCLUSION: The safety of RKP00156 
      was proved with no serious AEs. Although the study did not show any significance 
      in histologic regression and HPV clearance, our findings indicate that RKP00156 
      may have a possibility of short-term inhibitory effect on HPV replication in 
      patients with higher viral loads. TRIAL REGISTRATION: ClinicalTrials.gov 
      Identifier: NCT02139267.
CI  - (c) 2024. Asian Society of Gynecologic Oncology, Korean Society of Gynecologic 
      Oncology, and Japan Society of Gynecologic Oncology.
FAU - Cho, Hyun-Woong
AU  - Cho HW
AUID- ORCID: 0000-0002-7114-6301
AD  - Department of Obstetrics and Gynecology, Korea University Guro Hospital, Seoul, 
      Korea.
FAU - Jeong, Sohyeon
AU  - Jeong S
AUID- ORCID: 0000-0003-1354-0711
AD  - Department of Obstetrics and Gynecology, Korea University Guro Hospital, Seoul, 
      Korea.
FAU - Song, Seung Hun
AU  - Song SH
AUID- ORCID: 0000-0002-9192-8984
AD  - Comprehensive Gynecologic Cancer Center, CHA Bundang Medical Center, CHA 
      University, Seongnam, Korea.
FAU - Kim, Young Tae
AU  - Kim YT
AUID- ORCID: 0000-0002-7347-1052
AD  - Department of Obstetrics and Gynecology, Institute of Women's Life Medical 
      Science, Yonsei University College of Medicine, Seoul, Korea.
FAU - Kim, Jae-Weon
AU  - Kim JW
AUID- ORCID: 0000-0003-1835-9436
AD  - Department of Obstetrics and Gynecology, Seoul National University College of 
      Medicine, Seoul, Korea.
FAU - Cho, Chi-Heum
AU  - Cho CH
AUID- ORCID: 0000-0002-0437-4099
AD  - Department of Obstetrics and Gynecology, Keimyung University School of Medicine, 
      Daegu, Korea.
FAU - Hur, Soo Young
AU  - Hur SY
AUID- ORCID: 0000-0001-6563-2293
AD  - Department of Obstetrics and Gynecology, Seoul St. Mary's Hospital, College of 
      Medicine, The Catholic University of Korea, Seoul, Korea.
FAU - Chang, Suk-Joon
AU  - Chang SJ
AUID- ORCID: 0000-0002-0558-0038
AD  - Department of Obstetrics and Gynecology, Ajou University School of Medicine, 
      Suwon, Korea.
FAU - Kim, Yong Man
AU  - Kim YM
AUID- ORCID: 0000-0003-3391-4426
AD  - Department of Obstetrics and Gynecology, Asan Medical Center, University of 
      Ulsan, Seoul, Korea.
FAU - Lee, Jae Kwan
AU  - Lee JK
AUID- ORCID: 0000-0002-9727-3587
AD  - Department of Obstetrics and Gynecology, Korea University Guro Hospital, Seoul, 
      Korea. jklee38@korea.ac.kr.
LA  - eng
SI  - ClinicalTrials.gov/NCT02139267
GR  - KinoPharma/Japan
PT  - Journal Article
DEP - 20240124
PL  - Korea (South)
TA  - J Gynecol Oncol
JT  - Journal of gynecologic oncology
JID - 101483150
SB  - IM
OTO - NOTNLM
OT  - Human Papillomavirus Viruses
OT  - Uterine Cervical Dysplasia
OT  - Viral Load
OT  - Viral Replication Compartments
COIS- No potential conflict of interest relevant to this article was reported.
EDAT- 2024/02/08 18:42
MHDA- 2024/02/08 18:42
CRDT- 2024/02/08 16:43
PHST- 2023/07/31 00:00 [received]
PHST- 2023/12/15 00:00 [revised]
PHST- 2023/12/31 00:00 [accepted]
PHST- 2024/02/08 18:42 [medline]
PHST- 2024/02/08 18:42 [pubmed]
PHST- 2024/02/08 16:43 [entrez]
AID - 35.e52 [pii]
AID - 10.3802/jgo.2024.35.e52 [doi]
PST - aheadofprint
SO  - J Gynecol Oncol. 2024 Jan 24. doi: 10.3802/jgo.2024.35.e52.