Phase II AK Study in Organ Transplant Patients

Carcinoma, Squamous Cell Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00829192
• Other study ID #: CUV011
• Status: Active, not recruiting
• Phase: Phase 2
• First received: January 23, 2009
• Last updated: December 3, 2010
• Start date: November 2007
• Est. completion date: August 2012

Study information

• Verified date: December 2010
• Source: Clinuvel Pharmaceuticals Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether afamelanotide (CUV1647) is effective in reducing the number of actinic keratoses and squamous cell carcinomas developing in immune compromised organ transplant recipients, who are at particularly high risk, over a 24 month test period.

The number of lesions formed on the head, hands and forarms will be monitored over this 24 month test period.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: August 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Actinic Keratoses
• Carcinoma, Squamous Cell
• Keratosis
• Keratosis, Actinic
• Organ Transplant Recipients

Intervention

Drug:
• Afamelanotide (CUV1647)
16 mg subcutaneous implant administered every 60 days
• Placebo
Placebo subcutaneous implant administered every 60 days

Locations

Country	Name	City	State
Australia	The Queen Elizabeth Hospital	Adelaide	South Australia
Australia	The Princess Alexandra Hospital	Brisbane	Queensland
Australia	The Royal Melbourne Hospital	Melbourne	Victoria
Belgium	Hospital Erasme	Brussels
Belgium	Gent University Hospital	Gent
France	University Hospital	Besancon
Germany	Charité Univeritätsklinikum	Berlin
Germany	Kiel University Hospital	Kiel
Italy	Ospedali Riuniti di Bergamo	Bergamo
Italy	University of Padua	Padua
Sweden	Karolinska University Hospital	Stockholm
Switzerland	Universitätsspital Zürich	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Clinuvel Pharmaceuticals Limited

Countries where clinical trial is conducted

Australia,  Belgium,  France,  Germany,  Italy,  Sweden,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		24 months
Secondary	To determine and compare the proportion of patients in each group that develops one or more squamous cell carcinoma (SCC)		24 months
Secondary	To examine the effect of ongoing sun exposure on lesion formation and progression in the patient group		24 months
Secondary	To evaluate the safety and tolerability of multiple slow release subcutaneous implants of afamelanotide (CUV1647)		24 months