Know Cancer

or
forgot password

A Multicentre, Randomised, Double-Blind, Placebo Controlled, Phase II Study to Evaluate the Safety and Efficacy of Subcutaneous Bioresorbable Implants of Afamelanotide (CUV1647) for the Prophylactic Treatment of Pre-Cancerous Skin Lesions of the Head, Forearms and Hands in Immune Compromised, Organ Transplant Patients.


Phase 2
18 Years
75 Years
Open (Enrolling)
Both
Actinic Keratoses, Carcinoma, Squamous Cell, Organ Transplant Recipients

Thank you

Trial Information

A Multicentre, Randomised, Double-Blind, Placebo Controlled, Phase II Study to Evaluate the Safety and Efficacy of Subcutaneous Bioresorbable Implants of Afamelanotide (CUV1647) for the Prophylactic Treatment of Pre-Cancerous Skin Lesions of the Head, Forearms and Hands in Immune Compromised, Organ Transplant Patients.


Inclusion Criteria:



- Organ transplant recipients with stable transplant function and who received their
transplant at least 2 years prior to study entry

- Organ transplant patients who have had at least one biopsy-positive SCC

- Aged 18 - 75 years

- Written informed consent to the performance of all study-specific procedures

Exclusion Criteria:

- Allergy to afamelanotide (CUV1647) or the polymer contained in the implant

- History of melanoma

- Current pigmentary disorders such as melasma

- Diagnosed with HIV/AIDS, or hepatitis B or C

- Current history of drug or alcohol abuse (in the last 12 months)

- Clinically significant organ dysfunction, history of medical disorders or other
factors, which in the opinion of the investigator will interfere with the
interpretation of study outcome measures

- Major medical or psychiatric illness

- Pregnancy as confirmed by positive serum beta-HCG pregnancy test prior to baseline or
lactating mothers

- Females of child bearing potential not using adequate contraceptive measures

- Participation in a clinical trial for an investigational agent within 30 days prior
to the screening visit

- Use of regular medications or any other factors that may affect skin pigmentation

Discontinuation Criteria:

- Initiation of treatment with systemic retinoids

- Change of class of systemic immunosuppressant treatment

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Outcome Measure:

To determine the effect of afamelanotide (CUV1647) administered from slow release subcutaneous implants on the number of actinic keratoses (AKs) on the head, forearms and back of hands

Outcome Time Frame:

24 months

Principal Investigator

Günther Hofbauer, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Universitätsspital, Zürich

Authority:

Australia: Department of Health and Ageing Therapeutic Goods Administration

Study ID:

CUV011

NCT ID:

NCT00829192

Start Date:

November 2007

Completion Date:

August 2012

Related Keywords:

  • Actinic Keratoses
  • Carcinoma, Squamous Cell
  • Organ Transplant Recipients
  • Actinic keratoses (AK)
  • Squamous cell carcinomas (SCC)
  • CUV1647
  • Afamelanotide
  • Clinuvel
  • Photoprotection
  • Organ transplant
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Keratosis
  • Keratosis, Actinic

Name

Location