A Phase II Single-arm Intervention Trial of Nelfinavir in Patients With Grade 2/3 or 3 Cervical Intraepithelial Neoplasia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01925378|
Recruitment Status : Recruiting
First Posted : August 19, 2013
Last Update Posted : February 23, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cervical Dysplasia||Drug: Nelfinavir||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A PHASE II SINGLE-ARM INTERVENTION TRIAL OF NELFINAVIR IN PATIENTS WITH GRADE 2/3 or 3 CERVICAL INTRAEPITHELIAL NEOPLASIA|
|Study Start Date :||July 2012|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2022|
This is a single arm intervention trial of nelfinavir in women with grade 2/3 or grade 3 cervical intraepithelial neoplasia
All medications which a patient is taking will be reviewed at each visit, including the screening, day 1, weeks 4,12, 24.
All patients enrolled in the study will receive 1,250 mg twice PO daily for a 24 week duration.
Other Name: Viracept
- 1.1 Efficacy of Nelfinavir (NFV) to induce complete remission (or partial regression to CIN 1) of CIN 2/3 or CIN 3 as evaluated in the post-treatment excisional biopsy. [ Time Frame: 24 weeks ]
Parameters of response:
Histologic evaluation of the post-treatment LLETZ/cone specimen.
(1) Persistent with worst disease being CIN 3; (2) Persistent with worst disease being CIN 2/3; (3) Persistent with worst disease being CIN 2; (4) Persistent with worst disease being CIN 1; (5) Normal tissue; no evidence of CIN present; (6) Squamous cell carcinoma, in situ.
Histologic Complete Response will be judged as complete absence of any histologic evidence of CIN in the biopsy or LLETZ .
Histologic Partial Response will be judged as regression of CIN 2/3 or CIN 3 to persistent disease with worst grade being CIN 1 in the LLETZ cone biopsy.
Histologic Persistent Disease will be defined as evidence of CIN 2, CIN 2/3 or CIN 3 in the LLETZ/cone biopsy.
Histologic Progression: Evidence of disease progression such as invasive carcinoma.
- targeted mechanism of NFV in histological response [ Time Frame: 24 weeks ]Pathway inhibition will be demonstrated when there is a decrease of PI3K and/or Akt on IHC between the enrollment biopsy and the final biopsy or the LLETZ/cone specimen
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01925378
|Contact: Joseph A Lucci, MD||7135005691||Joseph.A.Lucci@uth.tmc.edu|
|Contact: Sonia C Robazetti, MD, CCRCemail@example.com|
|United States, Texas|
|The University of Texas Health Science Center at Houston||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Joseph A. Lucci, MD 713-500-5691 Joseph.A.Lucci@uth.tmc.edu|
|Contact: Sonia C Robazetti, MD,CCRC 7135006382 firstname.lastname@example.org|
|Principal Investigator:||Joseph A Lucci, MD||The University of Texas Health Science Center, Houston|