A Phase II, Multicentre, Double-blind, Placebo Controlled, Pilot Study to Evaluate the Safety and Efficacy of CUV1647 Administered as A Subcutaneous Bioresorbable 16mg Implant in Patients Undergoing Photodynamic Therapy (PDT) utilising Porfimer Sodium - Phase II PDT Pilot Study

Phase 1

• Conditions: Barrett's OesohagusCholangiocarcinoma; MedDRA version: 9.1Level: LLTClassification code 10004137Term: Barrett's oesophagus; MedDRA version: 9.1Level: LLTClassification code 10008593Term: Cholangiocarcinoma

• Registration Number: EUCTR2008-002446-39-FR
• Lead Sponsor: Clinuvel Pharmaceuticals Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-08-25
• Study Completion: 2009-05-28
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Male or female Caucasian subjects undergoing PDT with porfimer sodium.
• Aged greater than 18 years
• Fitzpatrick Skin Type I- IV

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Known allergy or hypersensitivity to CUV1647 or the polymer contained in the implant

Non-Caucasian patients

Personal history of melanoma or dysplastic nevus syndrome

Current Bowen’s disease, basal cell carcinoma, squamous cell carcinoma, or other malignant or premalignant skin lesions

Female who is pregnant (confirmed by positive serum ß-HCG pregnancy test prior to baseline) or lactating

Females of child-bearing potential (pre-menopausal, not surgically sterile) not using adequate contraceptive measures (i.e. oral contraceptives, diaphragm plus spermicide, intrauterine device)

Participation in a simultaneous clinical trial for another investigational agent or within 30 days prior to the screening visit

Patients unable to give informed consent

Patient needs for concomitant medication with potential photosensitizing effects e.g. antibiotics like tetracyclines.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine whether CUV1647 implants can reduce the period of phototoxicity experienced by patients who have undergone photodynamic therapy with porfimer sodium.;Secondary Objective: To evaluate the effect of CUV1647 treatment on the quality of life.<br>To evaluate the safety and tolerability of CUV1647 by measuring treatment-emergent adverse events.;Primary end point(s): Primary Efficacy endpoint:<br>The first day on which patients are free from dermal symptoms following evaluation of photo toxicity<br><br>Primary Safety Endpoint:<br>Type and incidence of treatment emergent adverse events.<br>