Condition category
Cancer
Date applied
17/12/2013
Date assigned
17/12/2013
Last edited
17/01/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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 measure

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 (if study stopped)

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

Sponsor information

Organisation

University of Birmingham (UK)

Sponsor details

Edgbaston
Birmingham
B15 2TT
United Kingdom

Sponsor type

University/education

Website

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

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

17/01/2018: The following changes were made: 1. The recruitment end date was changed from 01/01/2017 to 10/05/2017. 2. The overall trial end date was changed from 01/01/2017 to 30/11/2018. 3. Publication plan, intention to publish date and participant level data were added.