A Phase II Single-arm Intervention Trial of Nelfinavir in Patients With Grade 2/3 or 3 Cervical Intraepithelial Neoplasia
Status:
Withdrawn
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
Summary
Preliminary data showed that Nelfinavir has selective apoptotic effects on HPV+ cervical
tumor cell lines. Furthermore, in a Phase I clinical trial, the combination of NFV and
chemoradiotherapy showed acceptable toxicity and promising activity in patients with
pancreatic cancer. Therefore, for the proposed research, the principal investigator will use
a single-arm Phase II intervention trial study design with focus on the efficacy of NFV to
induce complete or partial remission of CIN 2/3 or CIN 3 as well as biomarker evaluation.
Phase:
Phase 2
Details
Lead Sponsor:
Joseph Anthony Lucci III The University of Texas Health Science Center, Houston
Collaborator:
The University of Texas Health Science Center, Houston