EUCTR2013-003107-19-GB
Active, not recruiting
Phase 1
Phase II clinical trial investigating the use of epigallocatechin-3-gallate (Veregen) in the treatment of vulval intraepithelial neoplasia - EPIVIN trial (v 1.0)
ConditionsVulval intraepithelial neoplasia (VIN)MedDRA version: 16.1Level: LLTClassification code 10057313Term: Vulval intraepithelial neoplasia grade IIISystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
DrugsVeregen
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Vulval intraepithelial neoplasia (VIN)
- Sponsor
- niversity of Birmingham
- Enrollment
- 26
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\= 18 years of age, histological confirmation of usual\-type vulval intraepithelial neoplasia (VIN3\)\*, 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, using a reliable method of contraception (excluding condoms), 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
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 28
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 28
Exclusion Criteria
- •Suspected anogenital carcinoma or those considered by the attending clinician to be at high risk of developing invasive disease; pregnant, breast feeding or trying to conceive; treated for VIN within the previous four weeks; known allergy to Veregen or any of its components; patients suffering from immunosuppressive disorder or taking immunosuppressives; unable to comply with the protocol.
Outcomes
Primary Outcomes
Not specified
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