Barrett's Oesohagus Cholangiocarcinoma MedDRA version: 9.1 Level: LLT Classification code 10004137 Term: Barrett's oesophagus MedDRA version: 9.1 Level: LLT Classification code 10008593 Term: Cholangiocarcinoma
Conditions
Interventions
Product Name: CUV1647 (Afamelanotide)
Product Code: CUV1647
Pharmaceutical Form: Implant
INN or Proposed INN: Afamelanotide
CAS Number: 75921-69-6
Current Sponsor code: CUV1647
Other descriptive name:
Sponsors
Clinuvel Pharmaceuticals Limited
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. To evaluate the safety and tolerability of CUV1647 by measuring treatment-emergent adverse events.;Primary end point(s): Primary Efficacy endpoint: The first day on which patients are free from dermal symptoms following evaluation of photo toxicity Primary Safety Endpoint: Type and incidence of treatment emergent adverse events. | — |
Countries
France
Outcome results
None listed