Plain English Summary
Trial website
Contact information
Type
Scientific
Primary contact
Miss Baljit Kaur
ORCID ID
Contact details
Cancer Research UK Clinical Trials Unit
School of Cancer Sciences
Edgbaston
Birmingham
B15 2TT
United Kingdom
-
b.kaur@bham.ac.uk
Additional identifiers
EudraCT number
2013-003107-19
ClinicalTrials.gov number
Protocol/serial number
15759
Study information
Scientific title
Phase II clinical trial investigating the use of EPIgallocatechin-3-gallate (Veregen) in the treatment of Vulval Intraepithelial Neoplasia
Acronym
EPIVIN
Study hypothesis
The aim of this early phase trial is to determine if Veregen is a tolerable treatment with a level of activity that warrants further investigation in a definitive phase III trial. The trial will include women with histological diagnosis of VIN3 (usual type) and who have not received any prior treatment in the preceding 4 weeks.
The primary objective objective of the trial is to determine whether topical application of epigallocatechin-3-gallate (Veregen) can induce histological resolution of VIN when assessed 32 weeks following the start of treatment.
The secondary objectives of the trial are to supplement the primary outcome with analyses of objective response, patient safety, drug compliance and acceptability, need for further treatment, and quality of life.
More details can be found at: http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=15759
Ethics approval
NRES Committee East Midlands - Derby, 20/12/2013, ref: 13/EM/0398
Study design
Randomised interventional treatment trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Topic: National Cancer Research Network; Subtopic: Gynaecological Cancer; Disease: Vulva
Intervention
1. Experimental arm, Veregen 10%
2. Placebo
Study Entry: Single Randomisation only
Intervention type
Drug
Phase
Phase II
Drug names
Epigallocatechin-3-gallate (Veregen)
Primary outcome measures
Primary Outcome; Timepoint(s): 32 weeks
Secondary outcome measures
Secondary outcome measures; Timepoint(s): 2, 4, 8, 16, 32 and 52 weeks
Overall trial start date
01/01/2014
Overall trial end date
30/11/2018
Reason abandoned
Eligibility
Participant inclusion criteria
1. Female ≥ 18 years of age
2. Histological confirmation of 'usual' type vulval intraepithelial neoplasia (VIN3)*
3. At least one lesion that can be accurately measured (using the RECIST 1.1 criteria) in at least one dimension with longest diameter ≥ 20 mm
4. Using a reliable method of contraception (excluding condoms)
5. Written informed consent to participate in the trial
* All histological material generated by this study will be assessed by Specialist Consultant in Gynaecological Pathology, 10% of biopsies will be independently reviewed by a second pathologist
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
Planned Sample Size: 56; UK Sample Size: 56
Participant exclusion criteria
1. Suspected anogenital carcinoma or those considered by the attending clinician to be at high risk of developing invasive disease
2. Pregnant, breastfeeding or trying to conceive
3. Treated for VIN within the previous four weeks
4. Known allergy to Veregen or any of its components
5. Patients suffering from immunosuppressive disorder or taking immunosuppressives
6. Unable to comply with the protocol
Recruitment start date
01/01/2014
Recruitment end date
10/05/2017
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Cancer Research UK Clinical Trials Unit
Birmingham
B15 2TT
United Kingdom
Funders
Funder type
Government
Funder name
National Institute for Health Research (NIHR) (UK)
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal by around 30/11/2019.
IPD sharing statement: The data sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
30/11/2019
Participant level data
To be made available at a later date
Results - basic reporting
Publication summary